Aurobindo Pharma Limited
NDC Database

Aurobindo Pharma Limited

NDC Database

National Drug Code (NDC) records including drug products, NDC numbers, nonproprietary names, dosage forms, strengths, labelers and marketing information.

Drug for Further Processing Bulk Ingredient
  • Total Records 869
  • Latest Marketing Date 2026-06-17
  • Data Source FDA
  • First Marketing Date 2004-10-22
All
869
View
Bulk Ingredient
337
View
Drug for Further Processing
532
View
Company Overview

Company

Aurobindo Pharma Limited

Country

India

Social Profiles

Company Snapshot

Aurobindo Pharma Limited

Plot no. 2, Maitrivihar, Ameerpet, Hyderabad - 500038 Andhra Pradesh

India

www.aurobindo.com/ info@aurobindo.com View on Map
NDC Records ( 869 records )
2015
19 Aug
Drug for Further Processing NDC: 59651-001

Nonproprietary Name

Omeprazole

Dosage Form

CAPSULE, DELAYED RELEASE

Strength

10 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-001

Substance

OMEPRAZOLE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2015-08-19

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2015
19 Aug
Drug for Further Processing NDC: 59651-002

Nonproprietary Name

Omeprazole

Dosage Form

CAPSULE, DELAYED RELEASE

Strength

20 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-002

Substance

OMEPRAZOLE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2015-08-19

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2015
19 Aug
Drug for Further Processing NDC: 59651-003

Nonproprietary Name

Omeprazole

Dosage Form

CAPSULE, DELAYED RELEASE

Strength

40 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-003

Substance

OMEPRAZOLE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2015-08-19

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2015
18 Sep
Bulk Ingredient NDC: 59651-004

Nonproprietary Name

Octreotide Acetate

Dosage Form

POWDER

Strength

1 kg/kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-004

Substance

OCTREOTIDE ACETATE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2015-09-18

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
25 Dec
Bulk Ingredient NDC: 59651-006

Nonproprietary Name

Olanzapine (Form-II)

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-006

Substance

OLANZAPINE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-12-25

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2022
23 Dec
Drug for Further Processing NDC: 59651-009

Nonproprietary Name

Ranolazine

Dosage Form

TABLET, FILM COATED, EXTENDED RELEASE

Strength

500 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-009

Substance

RANOLAZINE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2022-12-23

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2022
23 Dec
Drug for Further Processing NDC: 59651-010

Nonproprietary Name

Ranolazine

Dosage Form

TABLET, FILM COATED, EXTENDED RELEASE

Strength

1000 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-010

Substance

RANOLAZINE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2022-12-23

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2015
17 Nov
Bulk Ingredient NDC: 59651-011

Nonproprietary Name

Linaclotide

Dosage Form

POWDER

Strength

1 kg/kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-011

Substance

LINACLOTIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2015-11-17

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
12 Jan
Bulk Ingredient NDC: 59651-015

Nonproprietary Name

Mirabegron

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-015

Substance

MIRABEGRON

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-12

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
11 Jan
Bulk Ingredient NDC: 59651-017

Nonproprietary Name

Lorcaserin Hydrochloride Hemihydrate

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-017

Substance

LORCASERIN HYDROCHLORIDE HEMIHYDRATE

Product Type

BULK INGREDIENT

DEA Schedule

CIV

Start Marketing Date

2024-01-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2015
15 Dec
Drug for Further Processing NDC: 59651-022

Nonproprietary Name

Loperamide Hydrochloride

Dosage Form

TABLET

Strength

2 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-022

Substance

LOPERAMIDE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2015-12-15

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2018
20 Jul
Drug for Further Processing NDC: 59651-027

Nonproprietary Name

Cetirizine Hydrochloride

Dosage Form

CAPSULE

Strength

10 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-027

Substance

CETIRIZINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2018-07-20

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2018
20 Jul
Drug for Further Processing NDC: 59651-028

Nonproprietary Name

Cetirizine Hydrochloride

Dosage Form

CAPSULE

Strength

10 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-028

Substance

CETIRIZINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2018-07-20

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2025
02 Jan
Bulk Ingredient NDC: 59651-031

Nonproprietary Name

Desmopressin Acetate

Dosage Form

POWDER

Strength

1 kg/kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-031

Substance

DESMOPRESSIN ACETATE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2025-01-02

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2017
30 Oct
Drug for Further Processing NDC: 59651-033

Nonproprietary Name

Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride

Dosage Form

TABLET, FILM COATED, EXTENDED RELEASE

Strength

60; 120 mg/1; mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-033

Substance

FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2017-10-30

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2016
09 Nov
Drug for Further Processing NDC: 59651-034

Nonproprietary Name

Acetaminophen

Dosage Form

TABLET, EXTENDED RELEASE

Strength

650 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-034

Substance

ACETAMINOPHEN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2016-11-09

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2018
16 Apr
Drug for Further Processing NDC: 59651-035

Nonproprietary Name

Loratadine

Dosage Form

TABLET

Strength

10 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-035

Substance

LORATADINE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2018-04-16

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
12 Jan
Bulk Ingredient NDC: 59651-036

Nonproprietary Name

Teriflunomide

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-036

Substance

TERIFLUNOMIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-12

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
08 Dec
Bulk Ingredient NDC: 59651-038

Nonproprietary Name

Dofetilide

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-038

Substance

DOFETILIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-12-08

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2018
01 Mar
Drug for Further Processing NDC: 59651-044

Nonproprietary Name

Esomeprazole Magnesium

Dosage Form

CAPSULE, DELAYED RELEASE

Strength

20 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-044

Substance

ESOMEPRAZOLE MAGNESIUM DIHYDRATE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2018-03-01

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2018
06 Jun
Drug for Further Processing NDC: 59651-050

Nonproprietary Name

Omeprazole

Dosage Form

TABLET, DELAYED RELEASE

Strength

20 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-050

Substance

OMEPRAZOLE MAGNESIUM

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2018-06-06

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
14 Dec
Bulk Ingredient NDC: 59651-051

Nonproprietary Name

Apixaban

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-051

Substance

APIXABAN

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-12-14

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2016
26 Apr
Drug for Further Processing NDC: 59651-053

Nonproprietary Name

Famotidine

Dosage Form

TABLET, FILM COATED

Strength

20 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-053

Substance

FAMOTIDINE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2016-04-26

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
12 Jan
Bulk Ingredient NDC: 59651-056

Nonproprietary Name

Ezetimibe

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-056

Substance

EZETIMIBE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-12

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
12 Jan
Bulk Ingredient NDC: 59651-061

Nonproprietary Name

Dimethyl Fumarate

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-061

Substance

DIMETHYL FUMARATE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-12

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
11 Jan
Bulk Ingredient NDC: 59651-065

Nonproprietary Name

Canagliflozin

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-065

Substance

CANAGLIFLOZIN

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2017
17 Mar
Drug for Further Processing NDC: 59651-068

Nonproprietary Name

Guaifenesin and Dextromethorphan HBr

Dosage Form

TABLET, EXTENDED RELEASE

Strength

30; 600 mg/1; mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-068

Substance

DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2017-03-17

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2017
17 Mar
Drug for Further Processing NDC: 59651-069

Nonproprietary Name

Guaifenesin and Dextromethorphan HBr

Dosage Form

TABLET, EXTENDED RELEASE

Strength

60; 1200 mg/1; mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-069

Substance

DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2017-03-17

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2018
29 Jun
Drug for Further Processing NDC: 59651-072

Nonproprietary Name

Ibuprofen

Dosage Form

CAPSULE

Strength

200 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-072

Substance

IBUPROFEN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2018-06-29

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2018
11 Apr
Drug for Further Processing NDC: 59651-074

Nonproprietary Name

Loratadine

Dosage Form

TABLET, ORALLY DISINTEGRATING

Strength

10 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-074

Substance

LORATADINE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2018-04-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2017
08 Nov
Drug for Further Processing NDC: 59651-075

Nonproprietary Name

Ibuprofen

Dosage Form

TABLET

Strength

200 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-075

Substance

IBUPROFEN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2017-11-08

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2017
08 Nov
Drug for Further Processing NDC: 59651-078

Nonproprietary Name

Ibuprofen

Dosage Form

TABLET

Strength

200 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-078

Substance

IBUPROFEN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2017-11-08

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
17 Jan
Bulk Ingredient NDC: 59651-079

Nonproprietary Name

Sevelamer Hydrochloride

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-079

Substance

SEVELAMER HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-17

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
16 Jan
Bulk Ingredient NDC: 59651-080

Nonproprietary Name

Colesevelam Hydrochloride

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-080

Substance

COLESEVELAM HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-16

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2016
25 Nov
Bulk Ingredient NDC: 59651-089

Nonproprietary Name

Leuprolide Acetate

Dosage Form

POWDER

Strength

1 kg/kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-089

Substance

LEUPROLIDE ACETATE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2016-11-25

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
10 Jan
Bulk Ingredient NDC: 59651-090

Nonproprietary Name

Atovaquone

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-090

Substance

ATOVAQUONE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-10

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
11 Jan
Bulk Ingredient NDC: 59651-094

Nonproprietary Name

Dronedarone Hydrochloride

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-094

Substance

DRONEDARONE HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2017
28 Feb
Drug for Further Processing NDC: 59651-097

Nonproprietary Name

Cetirizine Hydrochloride

Dosage Form

TABLET

Strength

10 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-097

Substance

CETIRIZINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2017-02-28

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2017
28 Feb
Drug for Further Processing NDC: 59651-098

Nonproprietary Name

Cetirizine Hydrochloride

Dosage Form

TABLET

Strength

10 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-098

Substance

CETIRIZINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2017-02-28

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
12 Jan
Bulk Ingredient NDC: 59651-099

Nonproprietary Name

Amoxicillin

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-099

Substance

AMOXICILLIN

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-12

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
09 Jan
Bulk Ingredient NDC: 59651-100

Nonproprietary Name

Silodosin

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-100

Substance

SILODOSIN

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-09

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
18 Dec
Bulk Ingredient NDC: 59651-101

Nonproprietary Name

Eletriptan Hydrobromide

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-101

Substance

ELETRIPTAN HYDROBROMIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-12-18

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
12 Jan
Bulk Ingredient NDC: 59651-102

Nonproprietary Name

Darunavir Propylene Glycolate

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-102

Substance

DARUNAVIR

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-12

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
12 Dec
Bulk Ingredient NDC: 59651-103

Nonproprietary Name

Febuxostat

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-103

Substance

FEBUXOSTAT

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-12-12

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2019
21 Oct
Drug for Further Processing NDC: 59651-106

Nonproprietary Name

Guaifenesin

Dosage Form

TABLET, EXTENDED RELEASE

Strength

600 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-106

Substance

GUAIFENESIN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2019-10-21

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2019
21 Oct
Drug for Further Processing NDC: 59651-107

Nonproprietary Name

Guaifenesin

Dosage Form

TABLET, EXTENDED RELEASE

Strength

1200 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-107

Substance

GUAIFENESIN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2019-10-21

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
11 Jan
Bulk Ingredient NDC: 59651-108

Nonproprietary Name

Ganciclovir

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-108

Substance

GANCICLOVIR

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
11 Jan
Bulk Ingredient NDC: 59651-111

Nonproprietary Name

Fosaprepitant Dimeglumine

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-111

Substance

FOSAPREPITANT DIMEGLUMINE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2016
26 Apr
Drug for Further Processing NDC: 59651-112

Nonproprietary Name

Famotidine

Dosage Form

TABLET, FILM COATED

Strength

10 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-112

Substance

FAMOTIDINE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2016-04-26

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2019
14 Feb
Drug for Further Processing NDC: 59651-117

Nonproprietary Name

Diphenhydramine HCl and Ibuprofen

Dosage Form

CAPSULE, LIQUID FILLED

Strength

25; 200 mg/1; mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-117

Substance

DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2019-02-14

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
05 Jan
Bulk Ingredient NDC: 59651-122

Nonproprietary Name

Macitentan

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-122

Substance

MACITENTAN

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-05

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
05 Dec
Bulk Ingredient NDC: 59651-123

Nonproprietary Name

Flecainide Acetate

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-123

Substance

FLECAINIDE ACETATE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-12-05

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
14 Nov
Bulk Ingredient NDC: 59651-135

Nonproprietary Name

Dapagliflozin

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-135

Substance

DAPAGLIFLOZIN

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-11-14

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
08 Dec
Bulk Ingredient NDC: 59651-141

Nonproprietary Name

Isoproterenol Hydrochloride

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-141

Substance

ISOPROTERENOL HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-12-08

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
12 Jan
Bulk Ingredient NDC: 59651-148

Nonproprietary Name

Hydralazine Hydrochloride

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-148

Substance

HYDRALAZINE HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-12

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2020
14 Dec
Drug for Further Processing NDC: 59651-149

Nonproprietary Name

Loperamide Hydrochloride and Simethicone

Dosage Form

TABLET

Strength

125; 2 mg/1; mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-149

Substance

DIMETHICONE; LOPERAMIDE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2020-12-14

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
08 Jan
Bulk Ingredient NDC: 59651-150

Nonproprietary Name

Apremilast

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-150

Substance

APREMILAST

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-08

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
16 Jan
Bulk Ingredient NDC: 59651-151

Nonproprietary Name

Sumatriptan Succinate

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-151

Substance

SUMATRIPTAN SUCCINATE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-16

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2022
02 Feb
Drug for Further Processing NDC: 59651-158

Nonproprietary Name

acetaminophen, aspirin and caffeine

Dosage Form

TABLET, FILM COATED

Strength

250; 250; 65 mg/1; mg/1; mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-158

Substance

ACETAMINOPHEN; ASPIRIN; CAFFEINE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2022-02-02

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
10 Jan
Bulk Ingredient NDC: 59651-168

Nonproprietary Name

Carmustine

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-168

Substance

CARMUSTINE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-10

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
25 Dec
Bulk Ingredient NDC: 59651-172

Nonproprietary Name

Sodium Nitroprusside

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-172

Substance

SODIUM NITROPRUSSIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-12-25

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
14 Nov
Bulk Ingredient NDC: 59651-179

Nonproprietary Name

Empagliflozin

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-179

Substance

EMPAGLIFLOZIN

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-11-14

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
24 Mar
Drug for Further Processing NDC: 59651-185

Nonproprietary Name

Loratadine

Dosage Form

CAPSULE

Strength

10 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-185

Substance

LORATADINE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2023-03-24

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
06 Dec
Bulk Ingredient NDC: 59651-190

Nonproprietary Name

Ertapenem Sodium

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-190

Substance

ERTAPENEM SODIUM

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-12-06

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2017
11 Dec
Drug for Further Processing NDC: 59651-191

Nonproprietary Name

Naproxen Sodium

Dosage Form

TABLET, FILM COATED

Strength

220 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-191

Substance

NAPROXEN SODIUM

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2017-12-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
15 Nov
Bulk Ingredient NDC: 59651-199

Nonproprietary Name

Pirfenidone

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-199

Substance

PIRFENIDONE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-11-15

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
07 Dec
Bulk Ingredient NDC: 59651-222

Nonproprietary Name

Roflumilast

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-222

Substance

ROFLUMILAST

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-12-07

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
11 Jan
Bulk Ingredient NDC: 59651-223

Nonproprietary Name

Dichlorphenamide

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-223

Substance

DICHLORPHENAMIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
10 Jan
Bulk Ingredient NDC: 59651-230

Nonproprietary Name

Cephalexin

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-230

Substance

CEPHALEXIN

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-10

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
12 Jan
Bulk Ingredient NDC: 59651-231

Nonproprietary Name

Sitagliptin Phosphate

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-231

Substance

SITAGLIPTIN PHOSPHATE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-12

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
30 Dec
Bulk Ingredient NDC: 59651-237

Nonproprietary Name

Teriparatide

Dosage Form

POWDER

Strength

1 kg/kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-237

Substance

TERIPARATIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-12-30

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2018
23 Aug
Bulk Ingredient NDC: 59651-242

Nonproprietary Name

Vasopressin

Dosage Form

POWDER

Strength

1 kg/kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-242

Substance

VASOPRESSIN

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2018-08-23

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
11 Dec
Bulk Ingredient NDC: 59651-243

Nonproprietary Name

Neostigmine Methylsulfate

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-243

Substance

NEOSTIGMINE METHYLSULFATE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-12-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2025
04 Dec
Bulk Ingredient NDC: 59651-245

Nonproprietary Name

Penicillamine

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-245

Substance

PENICILLAMINE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2025-12-04

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2017
12 May
Drug for Further Processing NDC: 59651-268

Nonproprietary Name

Glipizide

Dosage Form

TABLET, EXTENDED RELEASE

Strength

2.5 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-268

Substance

GLIPIZIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2017-05-12

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2017
12 May
Drug for Further Processing NDC: 59651-269

Nonproprietary Name

Glipizide

Dosage Form

TABLET, EXTENDED RELEASE

Strength

5 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-269

Substance

GLIPIZIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2017-05-12

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2017
12 May
Drug for Further Processing NDC: 59651-270

Nonproprietary Name

Glipizide

Dosage Form

TABLET, EXTENDED RELEASE

Strength

10 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-270

Substance

GLIPIZIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2017-05-12

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
18 Jan
Bulk Ingredient NDC: 59651-274

Nonproprietary Name

Naloxegol Oxalate Premix

Dosage Form

POWDER

Strength

25 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING

59651-274

Substance

NALOXEGOL OXALATE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-18

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2019
30 Dec
Drug for Further Processing NDC: 59651-279

Nonproprietary Name

Duloxetine Hydrochloride

Dosage Form

CAPSULE, DELAYED RELEASE

Strength

20 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-279

Substance

DULOXETINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2019-12-30

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2019
30 Dec
Drug for Further Processing NDC: 59651-280

Nonproprietary Name

Duloxetine Hydrochloride

Dosage Form

CAPSULE, DELAYED RELEASE

Strength

30 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-280

Substance

DULOXETINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2019-12-30

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2019
30 Dec
Drug for Further Processing NDC: 59651-282

Nonproprietary Name

Duloxetine Hydrochloride

Dosage Form

CAPSULE, DELAYED RELEASE

Strength

60 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-282

Substance

DULOXETINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2019-12-30

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2020
25 Mar
Drug for Further Processing NDC: 59651-287

Nonproprietary Name

Guaifenesin and Pseudoephedrine HCl

Dosage Form

TABLET, EXTENDED RELEASE

Strength

600; 60 mg/1; mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-287

Substance

GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2020-03-25

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2020
25 Mar
Drug for Further Processing NDC: 59651-288

Nonproprietary Name

Guaifenesin and Pseudoephedrine HCl

Dosage Form

TABLET, EXTENDED RELEASE

Strength

1200; 120 mg/1; mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-288

Substance

GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2020-03-25

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
27 Nov
Drug for Further Processing NDC: 59651-291

Nonproprietary Name

ZAFIRLUKAST

Dosage Form

TABLET, FILM COATED

Strength

10 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-291

Substance

ZAFIRLUKAST

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2023-11-27

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
27 Nov
Drug for Further Processing NDC: 59651-292

Nonproprietary Name

ZAFIRLUKAST

Dosage Form

TABLET, FILM COATED

Strength

20 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-292

Substance

ZAFIRLUKAST

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2023-11-27

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
10 Jan
Bulk Ingredient NDC: 59651-298

Nonproprietary Name

Phenoxybenzamine Hydrochloride

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-298

Substance

PHENOXYBENZAMINE HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-10

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
17 Aug
Drug for Further Processing NDC: 59651-305

Nonproprietary Name

CHLORZOXAZONE

Dosage Form

TABLET

Strength

375 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-305

Substance

CHLORZOXAZONE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2023-08-17

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2020
03 Aug
Drug for Further Processing NDC: 59651-306

Nonproprietary Name

CHLORZOXAZONE

Dosage Form

TABLET

Strength

500 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-306

Substance

CHLORZOXAZONE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2020-08-03

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
17 Aug
Drug for Further Processing NDC: 59651-307

Nonproprietary Name

CHLORZOXAZONE

Dosage Form

TABLET

Strength

750 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-307

Substance

CHLORZOXAZONE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2023-08-17

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2020
08 Apr
Drug for Further Processing NDC: 59651-308

Nonproprietary Name

Fluoxetine

Dosage Form

TABLET, FILM COATED

Strength

10 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-308

Substance

FLUOXETINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2020-04-08

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2020
08 Apr
Drug for Further Processing NDC: 59651-309

Nonproprietary Name

Fluoxetine

Dosage Form

TABLET, FILM COATED

Strength

20 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-309

Substance

FLUOXETINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2020-04-08

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
28 Apr
Drug for Further Processing NDC: 59651-310

Nonproprietary Name

Omeprazole

Dosage Form

CAPSULE, DELAYED RELEASE

Strength

20 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-310

Substance

OMEPRAZOLE MAGNESIUM

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2023-04-28

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2020
24 Mar
Drug for Further Processing NDC: 59651-314

Nonproprietary Name

Tizanidine Hydrochloride

Dosage Form

CAPSULE

Strength

2 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-314

Substance

TIZANIDINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2020-03-24

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2020
24 Mar
Drug for Further Processing NDC: 59651-315

Nonproprietary Name

Tizanidine Hydrochloride

Dosage Form

CAPSULE

Strength

4 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-315

Substance

TIZANIDINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2020-03-24

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2020
24 Mar
Drug for Further Processing NDC: 59651-316

Nonproprietary Name

Tizanidine Hydrochloride

Dosage Form

CAPSULE

Strength

6 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-316

Substance

TIZANIDINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2020-03-24

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2020
10 Jun
Drug for Further Processing NDC: 59651-324

Nonproprietary Name

Fluoxetine

Dosage Form

TABLET, FILM COATED

Strength

60 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-324

Substance

FLUOXETINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2020-06-10

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
08 May
Drug for Further Processing NDC: 59651-327

Nonproprietary Name

PHENOXYBENZAMINE HYDROCHLORIDE

Dosage Form

CAPSULE

Strength

10 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-327

Substance

PHENOXYBENZAMINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2023-05-08

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
14 Dec
Bulk Ingredient NDC: 59651-328

Nonproprietary Name

Brexpiprazole

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-328

Substance

BREXPIPRAZOLE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-12-14

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
14 Nov
Bulk Ingredient NDC: 59651-330

Nonproprietary Name

Eluxadoline

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-330

Substance

ELUXADOLINE

Product Type

BULK INGREDIENT

DEA Schedule

CIV

Start Marketing Date

2023-11-14

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2020
01 May
Drug for Further Processing NDC: 59651-331

Nonproprietary Name

FLUCYTOSINE

Dosage Form

CAPSULE

Strength

250 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-331

Substance

FLUCYTOSINE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2020-05-01

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2020
01 May
Drug for Further Processing NDC: 59651-332

Nonproprietary Name

FLUCYTOSINE

Dosage Form

CAPSULE

Strength

500 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-332

Substance

FLUCYTOSINE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2020-05-01

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2025
29 Jul
Bulk Ingredient NDC: 59651-335

Nonproprietary Name

Sacubitril-Valsartan Premix

Dosage Form

POWDER

Strength

43 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING

59651-335

Substance

SACUBITRIL VALSARTAN SODIUM HYDRATE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2025-07-29

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
17 Jan
Bulk Ingredient NDC: 59651-336

Nonproprietary Name

Duloxetine Hydrochloride (Process II)

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-336

Substance

DULOXETINE HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-17

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2020
01 May
Drug for Further Processing NDC: 59651-337

Nonproprietary Name

Minocycline Hydrochloride

Dosage Form

TABLET, FILM COATED

Strength

50 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-337

Substance

MINOCYCLINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2020-05-01

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2020
01 May
Drug for Further Processing NDC: 59651-338

Nonproprietary Name

Minocycline Hydrochloride

Dosage Form

TABLET, FILM COATED

Strength

75 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-338

Substance

MINOCYCLINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2020-05-01

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2020
01 May
Drug for Further Processing NDC: 59651-339

Nonproprietary Name

Minocycline Hydrochloride

Dosage Form

TABLET, FILM COATED

Strength

100 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-339

Substance

MINOCYCLINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2020-05-01

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2022
14 Mar
Drug for Further Processing NDC: 59651-353

Nonproprietary Name

DICLOFENAC POTASSIUM

Dosage Form

CAPSULE, LIQUID FILLED

Strength

25 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-353

Substance

DICLOFENAC POTASSIUM

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2022-03-14

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2020
08 May
Drug for Further Processing NDC: 59651-360

Nonproprietary Name

Ibuprofen

Dosage Form

TABLET

Strength

400 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-360

Substance

IBUPROFEN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2020-05-08

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2020
08 May
Drug for Further Processing NDC: 59651-361

Nonproprietary Name

Ibuprofen

Dosage Form

TABLET

Strength

600 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-361

Substance

IBUPROFEN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2020-05-08

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2020
08 May
Drug for Further Processing NDC: 59651-362

Nonproprietary Name

Ibuprofen

Dosage Form

TABLET

Strength

800 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-362

Substance

IBUPROFEN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2020-05-08

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2020
10 Dec
Bulk Ingredient NDC: 59651-363

Nonproprietary Name

Icatibant Acetate

Dosage Form

POWDER

Strength

1 kg/kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-363

Substance

ICATIBANT ACETATE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2020-12-10

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
05 Dec
Bulk Ingredient NDC: 59651-364

Nonproprietary Name

Vigabatrin

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-364

Substance

VIGABATRIN

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-12-05

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
11 Jan
Bulk Ingredient NDC: 59651-365

Nonproprietary Name

Tipiracil Hydrochloride

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-365

Substance

TIPIRACIL HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
04 Dec
Bulk Ingredient NDC: 59651-374

Nonproprietary Name

Aripiprazole (Process II)

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-374

Substance

ARIPIPRAZOLE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-12-04

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2020
17 Aug
Drug for Further Processing NDC: 59651-378

Nonproprietary Name

ZONISAMIDE

Dosage Form

CAPSULE

Strength

25 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-378

Substance

ZONISAMIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2020-08-17

End Marketing Date

-

Listing Record Certified Through

2027-12-31

2020
17 Aug
Drug for Further Processing NDC: 59651-379

Nonproprietary Name

ZONISAMIDE

Dosage Form

CAPSULE

Strength

50 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-379

Substance

ZONISAMIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2020-08-17

End Marketing Date

-

Listing Record Certified Through

2027-12-31

2020
17 Aug
Drug for Further Processing NDC: 59651-380

Nonproprietary Name

ZONISAMIDE

Dosage Form

CAPSULE

Strength

100 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-380

Substance

ZONISAMIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2020-08-17

End Marketing Date

-

Listing Record Certified Through

2027-12-31

2023
20 Mar
Drug for Further Processing NDC: 59651-381

Nonproprietary Name

CLOMIPRAMINE HYDROCHLORIDE

Dosage Form

CAPSULE

Strength

25 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-381

Substance

CLOMIPRAMINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2023-03-20

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
20 Mar
Drug for Further Processing NDC: 59651-382

Nonproprietary Name

CLOMIPRAMINE HYDROCHLORIDE

Dosage Form

CAPSULE

Strength

50 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-382

Substance

CLOMIPRAMINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2023-03-20

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
20 Mar
Drug for Further Processing NDC: 59651-383

Nonproprietary Name

CLOMIPRAMINE HYDROCHLORIDE

Dosage Form

CAPSULE

Strength

75 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-383

Substance

CLOMIPRAMINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2023-03-20

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
11 Jan
Bulk Ingredient NDC: 59651-388

Nonproprietary Name

Trifluridine

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-388

Substance

TRIFLURIDINE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2021
13 Jul
Drug for Further Processing NDC: 59651-394

Nonproprietary Name

BACLOFEN

Dosage Form

TABLET

Strength

10 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-394

Substance

BACLOFEN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2021-07-13

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2021
13 Jul
Drug for Further Processing NDC: 59651-395

Nonproprietary Name

BACLOFEN

Dosage Form

TABLET

Strength

20 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-395

Substance

BACLOFEN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2021-07-13

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
11 Jan
Bulk Ingredient NDC: 59651-396

Nonproprietary Name

Mesalamine

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-396

Substance

MESALAMINE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
11 Jan
Bulk Ingredient NDC: 59651-398

Nonproprietary Name

Clopidogrel Bisulfate (Form II)

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-398

Substance

CLOPIDOGREL BISULFATE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
12 Jan
Bulk Ingredient NDC: 59651-399

Nonproprietary Name

Fluoxetine Hydrochloride Process II

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-399

Substance

FLUOXETINE HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-12

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
18 Jan
Bulk Ingredient NDC: 59651-400

Nonproprietary Name

Cariprazine Hydrochloride Premix

Dosage Form

POWDER

Strength

25 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING

59651-400

Substance

CARIPRAZINE HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-18

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
10 Jan
Bulk Ingredient NDC: 59651-403

Nonproprietary Name

Erythromycin Lactobionate

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-403

Substance

ERYTHROMYCIN LACTOBIONATE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-10

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
25 Dec
Bulk Ingredient NDC: 59651-409

Nonproprietary Name

Sugammadex Sodium

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-409

Substance

SUGAMMADEX SODIUM

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-12-25

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
14 Dec
Bulk Ingredient NDC: 59651-419

Nonproprietary Name

Deferasirox

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-419

Substance

DEFERASIROX

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-12-14

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2022
28 Nov
Drug for Further Processing NDC: 59651-421

Nonproprietary Name

Ursodiol

Dosage Form

CAPSULE

Strength

300 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-421

Substance

URSODIOL

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2022-11-28

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
18 Apr
Drug for Further Processing NDC: 59651-422

Nonproprietary Name

Cevimeline Hydrochloride

Dosage Form

CAPSULE

Strength

30 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-422

Substance

CEVIMELINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2023-04-18

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
12 Jul
Drug for Further Processing NDC: 59651-440

Nonproprietary Name

Esomeprazole Magnesium

Dosage Form

TABLET, DELAYED RELEASE

Strength

20 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-440

Substance

ESOMEPRAZOLE MAGNESIUM DIHYDRATE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2023-07-12

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2020
23 Sep
Drug for Further Processing NDC: 59651-441

Nonproprietary Name

Tramadol Hydrochloride

Dosage Form

TABLET, FILM COATED

Strength

50 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-441

Substance

TRAMADOL HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

CIV

Start Marketing Date

2020-09-23

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
11 Jan
Bulk Ingredient NDC: 59651-445

Nonproprietary Name

Lifitegrast

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-445

Substance

LIFITEGRAST

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
29 Apr
Drug for Further Processing NDC: 59651-446

Nonproprietary Name

COLCHICINE

Dosage Form

CAPSULE

Strength

0.6 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-446

Substance

COLCHICINE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2024-04-29

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2025
17 Apr
Drug for Further Processing NDC: 59651-454

Nonproprietary Name

Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride

Dosage Form

TABLET, FILM COATED, EXTENDED RELEASE

Strength

180; 240 mg/1; mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-454

Substance

FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2025-04-17

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2022
22 Mar
Drug for Further Processing NDC: 59651-455

Nonproprietary Name

Colchicine

Dosage Form

TABLET

Strength

0.6 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-455

Substance

COLCHICINE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2022-03-22

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
11 Jan
Bulk Ingredient NDC: 59651-468

Nonproprietary Name

Dasatinib

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-468

Substance

DASATINIB

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
11 Jan
Bulk Ingredient NDC: 59651-469

Nonproprietary Name

Ramelteon

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-469

Substance

RAMELTEON

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
10 Jan
Bulk Ingredient NDC: 59651-470

Nonproprietary Name

Ceftiofur Sodium

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-470

Substance

CEFTIOFUR SODIUM

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-10

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
11 Dec
Bulk Ingredient NDC: 59651-475

Nonproprietary Name

Paliperidone

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-475

Substance

PALIPERIDONE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-12-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
06 Dec
Bulk Ingredient NDC: 59651-476

Nonproprietary Name

Foscarnet Sodium

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-476

Substance

FOSCARNET SODIUM

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-12-06

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2020
03 Aug
Bulk Ingredient NDC: 59651-477

Nonproprietary Name

Degarelix

Dosage Form

POWDER

Strength

1 kg/kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-477

Substance

DEGARELIX

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2020-08-03

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
06 Dec
Bulk Ingredient NDC: 59651-482

Nonproprietary Name

Eslicarbazepine Acetate

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-482

Substance

ESLICARBAZEPINE ACETATE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-12-06

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
12 Jan
Bulk Ingredient NDC: 59651-483

Nonproprietary Name

Tenofovir Alafenamide Fumarate

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-483

Substance

TENOFOVIR ALAFENAMIDE FUMARATE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-12

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
16 Jan
Bulk Ingredient NDC: 59651-490

Nonproprietary Name

Docosanol

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-490

Substance

DOCOSANOL

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-16

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
10 Jan
Bulk Ingredient NDC: 59651-492

Nonproprietary Name

Safinamide Mesylate

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-492

Substance

SAFINAMIDE MESYLATE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-10

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
08 Dec
Bulk Ingredient NDC: 59651-496

Nonproprietary Name

Deutetrabenazine

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-496

Substance

DEUTETRABENAZINE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-12-08

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
23 Jan
Bulk Ingredient NDC: 59651-498

Nonproprietary Name

Azilsartan Kamedoxomil

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-498

Substance

AZILSARTAN KAMEDOXOMIL

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-23

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2021
07 Oct
Drug for Further Processing NDC: 59651-499

Nonproprietary Name

Hydroxyzine Hydrochloride

Dosage Form

TABLET, FILM COATED

Strength

10 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-499

Substance

HYDROXYZINE DIHYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2021-10-07

End Marketing Date

-

Listing Record Certified Through

2027-12-31

2021
07 Oct
Drug for Further Processing NDC: 59651-500

Nonproprietary Name

Hydroxyzine Hydrochloride

Dosage Form

TABLET, FILM COATED

Strength

25 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-500

Substance

HYDROXYZINE DIHYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2021-10-07

End Marketing Date

-

Listing Record Certified Through

2027-12-31

2021
07 Oct
Drug for Further Processing NDC: 59651-501

Nonproprietary Name

Hydroxyzine Hydrochloride

Dosage Form

TABLET, FILM COATED

Strength

50 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-501

Substance

HYDROXYZINE DIHYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2021-10-07

End Marketing Date

-

Listing Record Certified Through

2027-12-31

2020
11 Nov
Bulk Ingredient NDC: 59651-513

Nonproprietary Name

Etelcalcetide Hydrochloride

Dosage Form

POWDER

Strength

1 kg/kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-513

Substance

ETELCALCETIDE HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2020-11-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2020
19 Dec
Bulk Ingredient NDC: 59651-517

Nonproprietary Name

Glatiramer Acetate

Dosage Form

POWDER

Strength

1 kg/kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-517

Substance

GLATIRAMER ACETATE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2020-12-19

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
15 Apr
Drug for Further Processing NDC: 59651-548

Nonproprietary Name

Metformin Hydrochloride

Dosage Form

TABLET, EXTENDED RELEASE

Strength

500 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-548

Substance

METFORMIN HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2024-04-15

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
15 Apr
Drug for Further Processing NDC: 59651-549

Nonproprietary Name

Metformin Hydrochloride

Dosage Form

TABLET, EXTENDED RELEASE

Strength

750 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-549

Substance

METFORMIN HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2024-04-15

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2021
25 Mar
Bulk Ingredient NDC: 59651-552

Nonproprietary Name

Calcitonin Salmon

Dosage Form

POWDER

Strength

1 kg/kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-552

Substance

CALCITONIN SALMON

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2021-03-25

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
20 Nov
Drug for Further Processing NDC: 59651-553

Nonproprietary Name

Esomeprazole Magnesium

Dosage Form

CAPSULE, DELAYED RELEASE

Strength

20 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-553

Substance

ESOMEPRAZOLE MAGNESIUM

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2023-11-20

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
20 Nov
Drug for Further Processing NDC: 59651-561

Nonproprietary Name

ESOMEPRAZOLE MAGNESIUM

Dosage Form

CAPSULE, DELAYED RELEASE

Strength

20 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-561

Substance

ESOMEPRAZOLE MAGNESIUM TRIHYDRATE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2023-11-20

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
20 Nov
Drug for Further Processing NDC: 59651-562

Nonproprietary Name

ESOMEPRAZOLE MAGNESIUM

Dosage Form

CAPSULE, DELAYED RELEASE

Strength

40 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-562

Substance

ESOMEPRAZOLE MAGNESIUM TRIHYDRATE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2023-11-20

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
11 Jan
Bulk Ingredient NDC: 59651-564

Nonproprietary Name

Pyrimethamine

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-564

Substance

PYRIMETHAMINE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
11 Jan
Bulk Ingredient NDC: 59651-588

Nonproprietary Name

ivacaftor

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-588

Substance

IVACAFTOR

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2021
09 Jul
Bulk Ingredient NDC: 59651-592

Nonproprietary Name

Ganirelix Acetate

Dosage Form

POWDER

Strength

1 kg/kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-592

Substance

GANIRELIX ACETATE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2021-07-09

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
12 Dec
Bulk Ingredient NDC: 59651-598

Nonproprietary Name

Ertugliflozin L-Pyroglutamic Acid

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-598

Substance

ERTUGLIFLOZIN L-PYROGLUTAMIC ACID

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-12-12

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
20 Jan
Bulk Ingredient NDC: 59651-603

Nonproprietary Name

Ivacaftor Premix

Dosage Form

POWDER

Strength

38 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING

59651-603

Substance

IVACAFTOR

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-20

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
12 Jan
Bulk Ingredient NDC: 59651-605

Nonproprietary Name

Paclitaxel

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-605

Substance

PACLITAXEL

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-12

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
13 Feb
Drug for Further Processing NDC: 59651-606

Nonproprietary Name

ATORVASTATIN CALCIUM

Dosage Form

TABLET, FILM COATED

Strength

10 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-606

Substance

ATORVASTATIN CALCIUM TRIHYDRATE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2024-02-13

End Marketing Date

-

Listing Record Certified Through

2027-12-31

2024
13 Feb
Drug for Further Processing NDC: 59651-607

Nonproprietary Name

ATORVASTATIN CALCIUM

Dosage Form

TABLET, FILM COATED

Strength

20 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-607

Substance

ATORVASTATIN CALCIUM TRIHYDRATE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2024-02-13

End Marketing Date

-

Listing Record Certified Through

2027-12-31

2024
13 Feb
Drug for Further Processing NDC: 59651-608

Nonproprietary Name

ATORVASTATIN CALCIUM

Dosage Form

TABLET, FILM COATED

Strength

40 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-608

Substance

ATORVASTATIN CALCIUM TRIHYDRATE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2024-02-13

End Marketing Date

-

Listing Record Certified Through

2027-12-31

2024
13 Feb
Drug for Further Processing NDC: 59651-609

Nonproprietary Name

ATORVASTATIN CALCIUM

Dosage Form

TABLET, FILM COATED

Strength

80 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-609

Substance

ATORVASTATIN CALCIUM TRIHYDRATE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2024-02-13

End Marketing Date

-

Listing Record Certified Through

2027-12-31

2024
05 Jan
Bulk Ingredient NDC: 59651-610

Nonproprietary Name

Imatinib Mesylate

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-610

Substance

IMATINIB MESYLATE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-05

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
19 Jan
Bulk Ingredient NDC: 59651-614

Nonproprietary Name

Apalutamide Premix

Dosage Form

POWDER

Strength

12.5 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING

59651-614

Substance

APALUTAMIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-19

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
19 Jan
Bulk Ingredient NDC: 59651-618

Nonproprietary Name

Tezacaftor Premix

Dosage Form

POWDER

Strength

40 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING

59651-618

Substance

TEZACAFTOR

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-19

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2021
20 Sep
Bulk Ingredient NDC: 59651-619

Nonproprietary Name

Plecanatide

Dosage Form

POWDER

Strength

1 kg/kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-619

Substance

PLECANATIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2021-09-20

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
20 Jan
Bulk Ingredient NDC: 59651-620

Nonproprietary Name

Eltrombopag Olamine

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-620

Substance

ELTROMBOPAG OLAMINE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-20

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2019
02 Apr
Drug for Further Processing NDC: 59651-627

Nonproprietary Name

Ibuprofen

Dosage Form

CAPSULE

Strength

200 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-627

Substance

IBUPROFEN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2019-04-02

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2021
20 Aug
Drug for Further Processing NDC: 59651-628

Nonproprietary Name

Cetirizine Hydrochloride

Dosage Form

CAPSULE

Strength

10 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-628

Substance

CETIRIZINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2021-08-20

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
18 Dec
Bulk Ingredient NDC: 59651-639

Nonproprietary Name

Baricitinib

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-639

Substance

BARICITINIB

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-12-18

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2021
27 Apr
Drug for Further Processing NDC: 59651-640

Nonproprietary Name

IBUPROFEN AND PSEUDOEPHEDRINE HCL

Dosage Form

CAPSULE, LIQUID FILLED

Strength

200; 30 mg/1; mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-640

Substance

IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2021-04-27

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
18 Dec
Bulk Ingredient NDC: 59651-641

Nonproprietary Name

Encorafenib

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-641

Substance

ENCORAFENIB

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-12-18

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
17 Jan
Bulk Ingredient NDC: 59651-649

Nonproprietary Name

Sorafenib Tosylate

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-649

Substance

SORAFENIB TOSYLATE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-17

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
17 Jan
Bulk Ingredient NDC: 59651-656

Nonproprietary Name

Oxybutynin Chloride

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-656

Substance

OXYBUTYNIN CHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-17

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2022
15 Jul
Drug for Further Processing NDC: 59651-660

Nonproprietary Name

Famotidine

Dosage Form

TABLET, FILM COATED

Strength

20 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-660

Substance

FAMOTIDINE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2022-07-15

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2025
10 Dec
Bulk Ingredient NDC: 59651-661

Nonproprietary Name

Acetaminophen

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-661

Substance

ACETAMINOPHEN

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2025-12-10

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
11 Jan
Bulk Ingredient NDC: 59651-662

Nonproprietary Name

Migalastat Hydrochloride

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-662

Substance

MIGALASTAT HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2022
22 Mar
Drug for Further Processing NDC: 59651-676

Nonproprietary Name

Ibuprofen

Dosage Form

TABLET

Strength

200 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-676

Substance

IBUPROFEN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2022-03-22

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2022
22 Mar
Drug for Further Processing NDC: 59651-677

Nonproprietary Name

Ibuprofen

Dosage Form

TABLET

Strength

200 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-677

Substance

IBUPROFEN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2022-03-22

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
18 Dec
Bulk Ingredient NDC: 59651-683

Nonproprietary Name

Revefenacin

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-683

Substance

REVEFENACIN

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-12-18

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
06 Dec
Bulk Ingredient NDC: 59651-684

Nonproprietary Name

Melphalan Hydrochloride

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-684

Substance

MELPHALAN HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-12-06

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
18 Aug
Drug for Further Processing NDC: 59651-686

Nonproprietary Name

FLUPHENAZINE HYDROCHLORIDE

Dosage Form

TABLET

Strength

1 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-686

Substance

FLUPHENAZINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2023-08-18

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
18 Aug
Drug for Further Processing NDC: 59651-687

Nonproprietary Name

FLUPHENAZINE HYDROCHLORIDE

Dosage Form

TABLET

Strength

2.5 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-687

Substance

FLUPHENAZINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2023-08-18

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
18 Aug
Drug for Further Processing NDC: 59651-688

Nonproprietary Name

FLUPHENAZINE HYDROCHLORIDE

Dosage Form

TABLET

Strength

5 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-688

Substance

FLUPHENAZINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2023-08-18

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
18 Aug
Drug for Further Processing NDC: 59651-689

Nonproprietary Name

FLUPHENAZINE HYDROCHLORIDE

Dosage Form

TABLET

Strength

10 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-689

Substance

FLUPHENAZINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2023-08-18

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2022
31 May
Drug for Further Processing NDC: 59651-692

Nonproprietary Name

Ibuprofen and Diphenhydramine Citrate

Dosage Form

TABLET, COATED

Strength

38; 200 mg/1; mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-692

Substance

DIPHENHYDRAMINE CITRATE; IBUPROFEN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2022-05-31

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
11 Jan
Bulk Ingredient NDC: 59651-698

Nonproprietary Name

Ezetimibe

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-698

Substance

EZETIMIBE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2022
10 Aug
Drug for Further Processing NDC: 59651-700

Nonproprietary Name

Diphenhydramine HCl and Ibuprofen

Dosage Form

CAPSULE, LIQUID FILLED

Strength

25; 200 mg/1; mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-700

Substance

DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2022-08-10

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
22 Feb
Drug for Further Processing NDC: 59651-704

Nonproprietary Name

TRAZODONE HYDROCHLORIDE

Dosage Form

TABLET

Strength

50 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-704

Substance

TRAZODONE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2023-02-22

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
22 Feb
Drug for Further Processing NDC: 59651-705

Nonproprietary Name

TRAZODONE HYDROCHLORIDE

Dosage Form

TABLET

Strength

100 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-705

Substance

TRAZODONE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2023-02-22

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
22 Feb
Drug for Further Processing NDC: 59651-706

Nonproprietary Name

TRAZODONE HYDROCHLORIDE

Dosage Form

TABLET

Strength

150 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-706

Substance

TRAZODONE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2023-02-22

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
22 Feb
Drug for Further Processing NDC: 59651-707

Nonproprietary Name

TRAZODONE HYDROCHLORIDE

Dosage Form

TABLET

Strength

300 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-707

Substance

TRAZODONE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2023-02-22

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
10 Jan
Bulk Ingredient NDC: 59651-708

Nonproprietary Name

Abiraterone Acetate

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-708

Substance

ABIRATERONE ACETATE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-10

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
06 Dec
Bulk Ingredient NDC: 59651-709

Nonproprietary Name

Tafamidis Meglumine

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-709

Substance

TAFAMIDIS MEGLUMINE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-12-06

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
11 Jan
Bulk Ingredient NDC: 59651-710

Nonproprietary Name

Trametinib Acetic Acid

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-710

Substance

TRAMETINIB

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
23 Sep
Drug for Further Processing NDC: 59651-715

Nonproprietary Name

CLORAZEPATE DIPOTASSIUM

Dosage Form

TABLET

Strength

3.75 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-715

Substance

CLORAZEPATE DIPOTASSIUM

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

CIV

Start Marketing Date

2023-09-23

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
23 Sep
Drug for Further Processing NDC: 59651-716

Nonproprietary Name

CLORAZEPATE DIPOTASSIUM

Dosage Form

TABLET

Strength

7.5 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-716

Substance

CLORAZEPATE DIPOTASSIUM

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

CIV

Start Marketing Date

2023-09-23

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
23 Sep
Drug for Further Processing NDC: 59651-717

Nonproprietary Name

CLORAZEPATE DIPOTASSIUM

Dosage Form

TABLET

Strength

15 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-717

Substance

CLORAZEPATE DIPOTASSIUM

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

CIV

Start Marketing Date

2023-09-23

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
17 Jan
Drug for Further Processing NDC: 59651-722

Nonproprietary Name

CLONAZEPAM

Dosage Form

TABLET

Strength

0.5 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-722

Substance

CLONAZEPAM

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

CIV

Start Marketing Date

2023-01-17

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
17 Jan
Drug for Further Processing NDC: 59651-723

Nonproprietary Name

CLONAZEPAM

Dosage Form

TABLET

Strength

1 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-723

Substance

CLONAZEPAM

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

CIV

Start Marketing Date

2023-01-17

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
17 Jan
Drug for Further Processing NDC: 59651-724

Nonproprietary Name

CLONAZEPAM

Dosage Form

TABLET

Strength

2 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-724

Substance

CLONAZEPAM

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

CIV

Start Marketing Date

2023-01-17

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
06 Dec
Drug for Further Processing NDC: 59651-728

Nonproprietary Name

Cephalexin

Dosage Form

CAPSULE

Strength

750 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-728

Substance

CEPHALEXIN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2023-12-06

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
26 Mar
Drug for Further Processing NDC: 59651-731

Nonproprietary Name

Acetaminophen and Ibuprofen

Dosage Form

TABLET, FILM COATED

Strength

250; 125 mg/1; mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-731

Substance

ACETAMINOPHEN; IBUPROFEN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2024-03-26

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
18 Dec
Bulk Ingredient NDC: 59651-733

Nonproprietary Name

Lenalidomide

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-733

Substance

LENALIDOMIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-12-18

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
11 Jan
Bulk Ingredient NDC: 59651-734

Nonproprietary Name

Siponimod Fumaric Acid

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-734

Substance

SIPONIMOD HEMIFUMARIC ACID

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
18 Dec
Bulk Ingredient NDC: 59651-735

Nonproprietary Name

Dexrazoxane

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-735

Substance

DEXRAZOXANE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-12-18

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
28 Feb
Drug for Further Processing NDC: 59651-737

Nonproprietary Name

GLYCOPYRROLATE

Dosage Form

TABLET

Strength

1 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-737

Substance

GLYCOPYRROLATE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2023-02-28

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
28 Feb
Drug for Further Processing NDC: 59651-738

Nonproprietary Name

GLYCOPYRROLATE

Dosage Form

TABLET

Strength

2 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-738

Substance

GLYCOPYRROLATE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2023-02-28

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
17 Jan
Bulk Ingredient NDC: 59651-743

Nonproprietary Name

Tafamidis

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-743

Substance

TAFAMIDIS

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-17

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
26 Mar
Drug for Further Processing NDC: 59651-754

Nonproprietary Name

Acetaminophen and Ibuprofen

Dosage Form

TABLET, FILM COATED

Strength

250; 125 mg/1; mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-754

Substance

ACETAMINOPHEN; IBUPROFEN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2024-03-26

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
12 Jan
Bulk Ingredient NDC: 59651-755

Nonproprietary Name

Quetiapine Fumarate Process-II

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-755

Substance

QUETIAPINE FUMARATE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-12

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
07 Nov
Bulk Ingredient NDC: 59651-756

Nonproprietary Name

Solriamfetol Hydrochloride

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-756

Substance

SOLRIAMFETOL HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

CIV

Start Marketing Date

2023-11-07

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
18 Jan
Bulk Ingredient NDC: 59651-769

Nonproprietary Name

Dextromethorphan Polistirex

Dosage Form

POWDER

Strength

20 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING

59651-769

Substance

DEXTROMETHORPHAN HYDROBROMIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-18

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
16 Jan
Bulk Ingredient NDC: 59651-771

Nonproprietary Name

Ampicillin Trihydrate

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-771

Substance

AMPICILLIN TRIHYDRATE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-16

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
28 Dec
Bulk Ingredient NDC: 59651-772

Nonproprietary Name

Liraglutide

Dosage Form

POWDER

Strength

1 kg/kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-772

Substance

LIRAGLUTIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-12-28

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
03 Mar
Drug for Further Processing NDC: 59651-780

Nonproprietary Name

Glipizide

Dosage Form

TABLET, EXTENDED RELEASE

Strength

2.5 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-780

Substance

GLIPIZIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2023-03-03

End Marketing Date

-

Listing Record Certified Through

2027-12-31

2023
03 Mar
Drug for Further Processing NDC: 59651-781

Nonproprietary Name

Glipizide

Dosage Form

TABLET, EXTENDED RELEASE

Strength

5 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-781

Substance

GLIPIZIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2023-03-03

End Marketing Date

-

Listing Record Certified Through

2027-12-31

2023
03 Mar
Drug for Further Processing NDC: 59651-782

Nonproprietary Name

Glipizide

Dosage Form

TABLET, EXTENDED RELEASE

Strength

10 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-782

Substance

GLIPIZIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2023-03-03

End Marketing Date

-

Listing Record Certified Through

2027-12-31

2023
25 Dec
Bulk Ingredient NDC: 59651-788

Nonproprietary Name

Upadacitinib

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-788

Substance

UPADACITINIB

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-12-25

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2025
17 Jul
Drug for Further Processing NDC: 59651-796

Nonproprietary Name

FUROSEMIDE

Dosage Form

TABLET

Strength

20 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-796

Substance

FUROSEMIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2025-07-17

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2025
17 Jul
Drug for Further Processing NDC: 59651-797

Nonproprietary Name

FUROSEMIDE

Dosage Form

TABLET

Strength

40 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-797

Substance

FUROSEMIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2025-07-17

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2025
17 Jul
Drug for Further Processing NDC: 59651-798

Nonproprietary Name

FUROSEMIDE

Dosage Form

TABLET

Strength

80 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-798

Substance

FUROSEMIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2025-07-17

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
12 Nov
Drug for Further Processing NDC: 59651-823

Nonproprietary Name

CIMETIDINE

Dosage Form

TABLET, FILM COATED

Strength

200 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-823

Substance

CIMETIDINE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2024-11-12

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
12 Nov
Drug for Further Processing NDC: 59651-824

Nonproprietary Name

CIMETIDINE

Dosage Form

TABLET, FILM COATED

Strength

300 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-824

Substance

CIMETIDINE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2024-11-12

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
12 Nov
Drug for Further Processing NDC: 59651-825

Nonproprietary Name

CIMETIDINE

Dosage Form

TABLET, FILM COATED

Strength

400 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-825

Substance

CIMETIDINE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2024-11-12

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
12 Nov
Drug for Further Processing NDC: 59651-826

Nonproprietary Name

CIMETIDINE

Dosage Form

TABLET, FILM COATED

Strength

800 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-826

Substance

CIMETIDINE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2024-11-12

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
29 Mar
Drug for Further Processing NDC: 59651-854

Nonproprietary Name

Metformin Hydrochloride

Dosage Form

TABLET, FILM COATED

Strength

500 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-854

Substance

METFORMIN HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2024-03-29

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
29 Mar
Drug for Further Processing NDC: 59651-855

Nonproprietary Name

Metformin Hydrochloride

Dosage Form

TABLET, FILM COATED

Strength

850 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-855

Substance

METFORMIN HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2024-03-29

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
29 Mar
Drug for Further Processing NDC: 59651-856

Nonproprietary Name

Metformin Hydrochloride

Dosage Form

TABLET, FILM COATED

Strength

1000 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-856

Substance

METFORMIN HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2024-03-29

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
07 Nov
Bulk Ingredient NDC: 59651-858

Nonproprietary Name

Famotidine

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-858

Substance

FAMOTIDINE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-11-07

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
12 Jan
Bulk Ingredient NDC: 59651-859

Nonproprietary Name

Aztreoanm

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-859

Substance

AZTREONAM

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-12

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
10 Jan
Bulk Ingredient NDC: 59651-860

Nonproprietary Name

Ubrogepant

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-860

Substance

UBROGEPANT

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-10

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
11 Jan
Bulk Ingredient NDC: 59651-872

Nonproprietary Name

Azacitidine

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-872

Substance

AZACITIDINE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
23 Apr
Drug for Further Processing NDC: 59651-876

Nonproprietary Name

POLYETHYLENE GLYCOL 3350

Dosage Form

POWDER, FOR SOLUTION

Strength

17 g/17g

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-876

Substance

POLYETHYLENE GLYCOL 3350

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2024-04-23

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
11 Jan
Bulk Ingredient NDC: 59651-877

Nonproprietary Name

Ziprasidone Mesylate Trihydrate

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-877

Substance

ZIPRASIDONE MESYLATE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
11 Dec
Bulk Ingredient NDC: 59651-878

Nonproprietary Name

Paliperidone Palmitate

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-878

Substance

PALIPERIDONE PALMITATE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-12-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
08 Jan
Bulk Ingredient NDC: 59651-880

Nonproprietary Name

Bempedoic Acid

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-880

Substance

BEMPEDOIC ACID

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-08

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
02 Nov
Bulk Ingredient NDC: 59651-881

Nonproprietary Name

Cenobamate

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-881

Substance

CENOBAMATE

Product Type

BULK INGREDIENT

DEA Schedule

CV

Start Marketing Date

2023-11-02

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
29 Nov
Bulk Ingredient NDC: 59651-882

Nonproprietary Name

Gabapentin Enacarbil

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-882

Substance

GABAPENTIN ENACARBIL

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-11-29

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
29 Nov
Bulk Ingredient NDC: 59651-883

Nonproprietary Name

Amoxicillin Sodium

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-883

Substance

AMOXICILLIN SODIUM

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-11-29

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
08 Jan
Bulk Ingredient NDC: 59651-884

Nonproprietary Name

Rimegepant Sulfate

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-884

Substance

RIMEGEPANT SULFATE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-08

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
14 Sep
Drug for Further Processing NDC: 59651-890

Nonproprietary Name

IBUPROFEN

Dosage Form

CAPSULE, LIQUID FILLED

Strength

200 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-890

Substance

IBUPROFEN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2023-09-14

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2025
11 Jul
Drug for Further Processing NDC: 59651-898

Nonproprietary Name

Fluoxetine

Dosage Form

CAPSULE

Strength

10 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-898

Substance

FLUOXETINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2025-07-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2025
11 Jul
Drug for Further Processing NDC: 59651-899

Nonproprietary Name

Fluoxetine

Dosage Form

CAPSULE

Strength

20 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-899

Substance

FLUOXETINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2025-07-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2025
11 Jul
Drug for Further Processing NDC: 59651-900

Nonproprietary Name

Fluoxetine

Dosage Form

CAPSULE

Strength

40 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-900

Substance

FLUOXETINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2025-07-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
29 Dec
Bulk Ingredient NDC: 59651-924

Nonproprietary Name

Raltegravir Potassium

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-924

Substance

RALTEGRAVIR POTASSIUM

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-12-29

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
29 Jan
Bulk Ingredient NDC: 59651-930

Nonproprietary Name

Cephapirin Benzathine Process-II

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-930

Substance

CEPHAPIRIN BENZATHINE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-29

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
23 Jan
Bulk Ingredient NDC: 59651-938

Nonproprietary Name

Triheptanoin

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-938

Substance

TRIHEPTANOIN

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-23

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
15 Feb
Bulk Ingredient NDC: 59651-944

Nonproprietary Name

Sulbactam Sodium Sterile Process-II

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-944

Substance

SULBACTAM SODIUM

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-02-15

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
20 Feb
Bulk Ingredient NDC: 59651-946

Nonproprietary Name

Abacavir Sulfate (Process II)

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-946

Substance

ABACAVIR SULFATE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-02-20

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
20 Feb
Bulk Ingredient NDC: 59651-947

Nonproprietary Name

Cefdinir (Anhydrous)

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-947

Substance

CEFDINIR

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-02-20

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
11 Apr
Bulk Ingredient NDC: 59651-953

Nonproprietary Name

Pantoprazole Sodium Process-II

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-953

Substance

PANTOPRAZOLE SODIUM

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-04-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
25 Apr
Bulk Ingredient NDC: 59651-954

Nonproprietary Name

Lacosamide (CIP Process)

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-954

Substance

LACOSAMIDE

Product Type

BULK INGREDIENT

DEA Schedule

CV

Start Marketing Date

2024-04-25

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
11 Mar
Bulk Ingredient NDC: 59651-955

Nonproprietary Name

Cefpodoxime Proxetil (Process-II)

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-955

Substance

CEFPODOXIME PROXETIL

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-03-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
25 Apr
Bulk Ingredient NDC: 59651-967

Nonproprietary Name

Fluconazole (CIP Process)

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-967

Substance

FLUCONAZOLE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-04-25

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2025
27 Mar
Drug for Further Processing NDC: 59651-976

Nonproprietary Name

Ciprofloxacin Hydrochloride

Dosage Form

TABLET, FILM COATED

Strength

250 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-976

Substance

CIPROFLOXACIN HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2025-03-27

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2025
27 Mar
Drug for Further Processing NDC: 59651-977

Nonproprietary Name

Ciprofloxacin Hydrochloride

Dosage Form

TABLET, FILM COATED

Strength

500 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-977

Substance

CIPROFLOXACIN HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2025-03-27

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2025
27 Mar
Drug for Further Processing NDC: 59651-978

Nonproprietary Name

Ciprofloxacin Hydrochloride

Dosage Form

TABLET, FILM COATED

Strength

750 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-978

Substance

CIPROFLOXACIN HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2025-03-27

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
30 Aug
Bulk Ingredient NDC: 59651-990

Nonproprietary Name

Glycerol Phenylbutyrate

Dosage Form

LIQUID

Strength

1 kg/kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-990

Substance

GLYCEROL PHENYLBUTYRATE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-08-30

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
26 Aug
Bulk Ingredient NDC: 59651-991

Nonproprietary Name

6-Aminopenicillanic Acid

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

59651-991

Substance

6-AMINOPENICILLANIC ACID

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-08-26

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2025
29 Dec
Drug for Further Processing NDC: 59651-994

Nonproprietary Name

LOPERAMIDE HYDROCHLORIDE

Dosage Form

CAPSULE, LIQUID FILLED

Strength

2 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

59651-994

Substance

LOPERAMIDE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2025-12-29

End Marketing Date

-

Listing Record Certified Through

2027-12-31

2004
22 Oct
Drug for Further Processing NDC: 65862-001

Nonproprietary Name

Mirtazapine

Dosage Form

TABLET, FILM COATED

Strength

7.5 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-001

Substance

MIRTAZAPINE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2004-10-22

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2004
22 Oct
Drug for Further Processing NDC: 65862-003

Nonproprietary Name

Mirtazapine

Dosage Form

TABLET, FILM COATED

Strength

30 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-003

Substance

MIRTAZAPINE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2004-10-22

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2004
28 Oct
Drug for Further Processing NDC: 65862-005

Nonproprietary Name

Citalopram Hydrobromide

Dosage Form

TABLET, FILM COATED

Strength

10 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-005

Substance

CITALOPRAM HYDROBROMIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2004-10-28

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2004
28 Oct
Drug for Further Processing NDC: 65862-006

Nonproprietary Name

Citalopram Hydrobromide

Dosage Form

TABLET, FILM COATED

Strength

20 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-006

Substance

CITALOPRAM HYDROBROMIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2004-10-28

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2004
28 Oct
Drug for Further Processing NDC: 65862-007

Nonproprietary Name

Citalopram Hydrobromide

Dosage Form

TABLET, FILM COATED

Strength

40 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-007

Substance

CITALOPRAM HYDROBROMIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2004-10-28

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2005
14 Jan
Drug for Further Processing NDC: 65862-008

Nonproprietary Name

Metformin Hydrochloride

Dosage Form

TABLET, FILM COATED

Strength

500 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-008

Substance

METFORMIN HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2005-01-14

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2005
14 Jan
Drug for Further Processing NDC: 65862-009

Nonproprietary Name

Metformin Hydrochloride

Dosage Form

TABLET, FILM COATED

Strength

850 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-009

Substance

METFORMIN HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2005-01-14

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2005
14 Jan
Drug for Further Processing NDC: 65862-010

Nonproprietary Name

Metformin Hydrochloride

Dosage Form

TABLET, FILM COATED

Strength

1000 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-010

Substance

METFORMIN HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2005-01-14

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2007
06 Feb
Drug for Further Processing NDC: 65862-011

Nonproprietary Name

Sertraline Hydrochloride

Dosage Form

TABLET, FILM COATED

Strength

25 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-011

Substance

SERTRALINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2007-02-06

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2007
06 Feb
Drug for Further Processing NDC: 65862-012

Nonproprietary Name

Sertraline Hydrochloride

Dosage Form

TABLET, FILM COATED

Strength

50 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-012

Substance

SERTRALINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2007-02-06

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2007
06 Feb
Drug for Further Processing NDC: 65862-013

Nonproprietary Name

Sertraline Hydrochloride

Dosage Form

TABLET, FILM COATED

Strength

100 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-013

Substance

SERTRALINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2007-02-06

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2005
09 Nov
Drug for Further Processing NDC: 65862-014

Nonproprietary Name

Amoxicillin

Dosage Form

TABLET, FILM COATED

Strength

500 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-014

Substance

AMOXICILLIN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2005-11-09

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2005
09 Nov
Drug for Further Processing NDC: 65862-015

Nonproprietary Name

Amoxicillin

Dosage Form

TABLET, FILM COATED

Strength

875 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-015

Substance

AMOXICILLIN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2005-11-09

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2005
11 Sep
Drug for Further Processing NDC: 65862-016

Nonproprietary Name

Amoxicillin

Dosage Form

CAPSULE

Strength

250 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-016

Substance

AMOXICILLIN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2005-09-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2005
11 Sep
Drug for Further Processing NDC: 65862-017

Nonproprietary Name

Amoxicillin

Dosage Form

CAPSULE

Strength

500 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-017

Substance

AMOXICILLIN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2005-09-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2005
16 Nov
Drug for Further Processing NDC: 65862-018

Nonproprietary Name

Cephalexin

Dosage Form

CAPSULE

Strength

250 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-018

Substance

CEPHALEXIN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2005-11-16

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2005
16 Nov
Drug for Further Processing NDC: 65862-019

Nonproprietary Name

Cephalexin

Dosage Form

CAPSULE

Strength

500 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-019

Substance

CEPHALEXIN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2005-11-16

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2005
08 Dec
Drug for Further Processing NDC: 65862-021

Nonproprietary Name

Mirtazapine

Dosage Form

TABLET, ORALLY DISINTEGRATING

Strength

15 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-021

Substance

MIRTAZAPINE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2005-12-08

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2005
08 Dec
Drug for Further Processing NDC: 65862-022

Nonproprietary Name

Mirtazapine

Dosage Form

TABLET, ORALLY DISINTEGRATING

Strength

30 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-022

Substance

MIRTAZAPINE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2005-12-08

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2005
08 Dec
Drug for Further Processing NDC: 65862-023

Nonproprietary Name

Mirtazapine

Dosage Form

TABLET, ORALLY DISINTEGRATING

Strength

45 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-023

Substance

MIRTAZAPINE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2005-12-08

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2005
19 Sep
Drug for Further Processing NDC: 65862-024

Nonproprietary Name

Zidovudine

Dosage Form

TABLET, FILM COATED

Strength

300 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-024

Substance

ZIDOVUDINE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2005-09-19

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2016
21 Nov
Drug for Further Processing NDC: 65862-025

Nonproprietary Name

Lamivudine

Dosage Form

TABLET, FILM COATED

Strength

150 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-025

Substance

LAMIVUDINE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2016-11-21

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2016
21 Nov
Drug for Further Processing NDC: 65862-026

Nonproprietary Name

Lamivudine

Dosage Form

TABLET, FILM COATED

Strength

300 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-026

Substance

LAMIVUDINE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2016-11-21

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2012
22 May
Drug for Further Processing NDC: 65862-027

Nonproprietary Name

Nevirapine

Dosage Form

TABLET

Strength

200 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-027

Substance

NEVIRAPINE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2012-05-22

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2004
22 Oct
Drug for Further Processing NDC: 65862-031

Nonproprietary Name

Mirtazapine

Dosage Form

TABLET, FILM COATED

Strength

15 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-031

Substance

MIRTAZAPINE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2004-10-22

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2004
22 Oct
Drug for Further Processing NDC: 65862-032

Nonproprietary Name

Mirtazapine

Dosage Form

TABLET, FILM COATED

Strength

45 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-032

Substance

MIRTAZAPINE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2004-10-22

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2017
05 May
Drug for Further Processing NDC: 65862-036

Nonproprietary Name

Lamivudine and Zidovudine

Dosage Form

TABLET, FILM COATED

Strength

150; 300 mg/1; mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-036

Substance

LAMIVUDINE; ZIDOVUDINE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2017-05-05

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2006
22 Feb
Drug for Further Processing NDC: 65862-037

Nonproprietary Name

Lisinopril

Dosage Form

TABLET

Strength

2.5 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-037

Substance

LISINOPRIL

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2006-02-22

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2006
22 Feb
Drug for Further Processing NDC: 65862-038

Nonproprietary Name

Lisinopril

Dosage Form

TABLET

Strength

5 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-038

Substance

LISINOPRIL

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2006-02-22

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2006
22 Feb
Drug for Further Processing NDC: 65862-039

Nonproprietary Name

Lisinopril

Dosage Form

TABLET

Strength

10 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-039

Substance

LISINOPRIL

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2006-02-22

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2006
22 Feb
Drug for Further Processing NDC: 65862-040

Nonproprietary Name

Lisinopril

Dosage Form

TABLET

Strength

20 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-040

Substance

LISINOPRIL

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2006-02-22

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2006
22 Feb
Drug for Further Processing NDC: 65862-041

Nonproprietary Name

Lisinopril

Dosage Form

TABLET

Strength

30 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-041

Substance

LISINOPRIL

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2006-02-22

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2006
22 Feb
Drug for Further Processing NDC: 65862-042

Nonproprietary Name

Lisinopril

Dosage Form

TABLET

Strength

40 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-042

Substance

LISINOPRIL

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2006-02-22

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2006
14 Mar
Drug for Further Processing NDC: 65862-043

Nonproprietary Name

Lisinopril and Hydrochlorothiazide

Dosage Form

TABLET

Strength

12.5; 10 mg/1; mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-043

Substance

HYDROCHLOROTHIAZIDE; LISINOPRIL

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2006-03-14

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2006
14 Mar
Drug for Further Processing NDC: 65862-044

Nonproprietary Name

Lisinopril and Hydrochlorothiazide

Dosage Form

TABLET

Strength

12.5; 20 mg/1; mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-044

Substance

HYDROCHLOROTHIAZIDE; LISINOPRIL

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2006-03-14

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2006
14 Mar
Drug for Further Processing NDC: 65862-045

Nonproprietary Name

Lisinopril and Hydrochlorothiazide

Dosage Form

TABLET

Strength

25; 20 mg/1; mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-045

Substance

HYDROCHLOROTHIAZIDE; LISINOPRIL

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2006-03-14

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2018
21 Sep
Drug for Further Processing NDC: 65862-049

Nonproprietary Name

Efavirenz

Dosage Form

TABLET, FILM COATED

Strength

600 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-049

Substance

EFAVIRENZ

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2018-09-21

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2006
20 Dec
Drug for Further Processing NDC: 65862-050

Nonproprietary Name

Simvastatin

Dosage Form

TABLET, FILM COATED

Strength

5 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-050

Substance

SIMVASTATIN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2006-12-20

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2006
20 Dec
Drug for Further Processing NDC: 65862-051

Nonproprietary Name

Simvastatin

Dosage Form

TABLET, FILM COATED

Strength

10 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-051

Substance

SIMVASTATIN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2006-12-20

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2006
20 Dec
Drug for Further Processing NDC: 65862-052

Nonproprietary Name

Simvastatin

Dosage Form

TABLET, FILM COATED

Strength

20 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-052

Substance

SIMVASTATIN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2006-12-20

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2006
20 Dec
Drug for Further Processing NDC: 65862-053

Nonproprietary Name

Simvastatin

Dosage Form

TABLET, FILM COATED

Strength

40 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-053

Substance

SIMVASTATIN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2006-12-20

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2006
20 Dec
Drug for Further Processing NDC: 65862-054

Nonproprietary Name

Simvastatin

Dosage Form

TABLET, FILM COATED

Strength

80 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-054

Substance

SIMVASTATIN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2006-12-20

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2008
07 Oct
Drug for Further Processing NDC: 65862-058

Nonproprietary Name

Fluconazole

Dosage Form

TABLET

Strength

50 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-058

Substance

FLUCONAZOLE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2008-10-07

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2008
07 Oct
Drug for Further Processing NDC: 65862-059

Nonproprietary Name

Fluconazole

Dosage Form

TABLET

Strength

100 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-059

Substance

FLUCONAZOLE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2008-10-07

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2008
07 Oct
Drug for Further Processing NDC: 65862-060

Nonproprietary Name

Fluconazole

Dosage Form

TABLET

Strength

150 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-060

Substance

FLUCONAZOLE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2008-10-07

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2008
07 Oct
Drug for Further Processing NDC: 65862-061

Nonproprietary Name

Fluconazole

Dosage Form

TABLET

Strength

200 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-061

Substance

FLUCONAZOLE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2008-10-07

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2007
11 Sep
Drug for Further Processing NDC: 65862-062

Nonproprietary Name

Metoprolol Tartrate

Dosage Form

TABLET, FILM COATED

Strength

25 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-062

Substance

METOPROLOL TARTRATE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2007-09-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2007
11 Sep
Drug for Further Processing NDC: 65862-063

Nonproprietary Name

Metoprolol Tartrate

Dosage Form

TABLET, FILM COATED

Strength

50 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-063

Substance

METOPROLOL TARTRATE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2007-09-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2007
11 Sep
Drug for Further Processing NDC: 65862-064

Nonproprietary Name

Metoprolol Tartrate

Dosage Form

TABLET, FILM COATED

Strength

100 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-064

Substance

METOPROLOL TARTRATE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2007-09-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2007
24 May
Drug for Further Processing NDC: 65862-068

Nonproprietary Name

Cefprozil

Dosage Form

TABLET, FILM COATED

Strength

250 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-068

Substance

CEFPROZIL

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2007-05-24

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2007
24 May
Drug for Further Processing NDC: 65862-069

Nonproprietary Name

Cefprozil

Dosage Form

TABLET, FILM COATED

Strength

500 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-069

Substance

CEFPROZIL

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2007-05-24

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2012
17 Dec
Drug for Further Processing NDC: 65862-073

Nonproprietary Name

Abacavir

Dosage Form

TABLET, FILM COATED

Strength

300 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-073

Substance

ABACAVIR SULFATE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2012-12-17

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2007
02 Jul
Drug for Further Processing NDC: 65862-079

Nonproprietary Name

Terbinafine Hydrochloride

Dosage Form

TABLET

Strength

250 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-079

Substance

TERBINAFINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2007-07-02

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2007
14 Nov
Drug for Further Processing NDC: 65862-080

Nonproprietary Name

Glyburide and Metformin Hydrochloride

Dosage Form

TABLET, FILM COATED

Strength

1.25; 250 mg/1; mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-080

Substance

GLYBURIDE; METFORMIN HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2007-11-14

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2007
14 Nov
Drug for Further Processing NDC: 65862-081

Nonproprietary Name

Glyburide and Metformin Hydrochloride

Dosage Form

TABLET, FILM COATED

Strength

2.5; 500 mg/1; mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-081

Substance

GLYBURIDE; METFORMIN HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2007-11-14

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2007
14 Nov
Drug for Further Processing NDC: 65862-082

Nonproprietary Name

Glyburide and Metformin Hydrochloride

Dosage Form

TABLET, FILM COATED

Strength

5; 500 mg/1; mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-082

Substance

GLYBURIDE; METFORMIN HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2007-11-14

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2007
25 Jan
Drug for Further Processing NDC: 65862-085

Nonproprietary Name

Cefadroxil

Dosage Form

CAPSULE

Strength

500 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-085

Substance

CEFADROXIL

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2007-01-25

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2006
27 Dec
Drug for Further Processing NDC: 65862-086

Nonproprietary Name

Bisoprolol Fumarate

Dosage Form

TABLET, FILM COATED

Strength

5 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-086

Substance

BISOPROLOL FUMARATE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2006-12-27

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2006
27 Dec
Drug for Further Processing NDC: 65862-087

Nonproprietary Name

Bisoprolol Fumarate

Dosage Form

TABLET, FILM COATED

Strength

10 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-087

Substance

BISOPROLOL FUMARATE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2006-12-27

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2007
11 Jun
Drug for Further Processing NDC: 65862-095

Nonproprietary Name

CEFPODOXIME PROXETIL

Dosage Form

TABLET, FILM COATED

Strength

100 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-095

Substance

CEFPODOXIME PROXETIL

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2007-06-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2007
11 Jun
Drug for Further Processing NDC: 65862-096

Nonproprietary Name

CEFPODOXIME PROXETIL

Dosage Form

TABLET, FILM COATED

Strength

200 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-096

Substance

CEFPODOXIME PROXETIL

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2007-06-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2006
02 Oct
Drug for Further Processing NDC: 65862-097

Nonproprietary Name

Meloxicam

Dosage Form

TABLET

Strength

7.5 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-097

Substance

MELOXICAM

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2006-10-02

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2006
02 Oct
Drug for Further Processing NDC: 65862-098

Nonproprietary Name

Meloxicam

Dosage Form

TABLET

Strength

15 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-098

Substance

MELOXICAM

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2006-10-02

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2007
17 Jul
Drug for Further Processing NDC: 65862-101

Nonproprietary Name

Amlodipine Besylate

Dosage Form

TABLET

Strength

2.5 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-101

Substance

AMLODIPINE BESYLATE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2007-07-17

End Marketing Date

-

Listing Record Certified Through

2027-12-31

2007
17 Jul
Drug for Further Processing NDC: 65862-102

Nonproprietary Name

Amlodipine Besylate

Dosage Form

TABLET

Strength

5 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-102

Substance

AMLODIPINE BESYLATE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2007-07-17

End Marketing Date

-

Listing Record Certified Through

2027-12-31

2007
17 Jul
Drug for Further Processing NDC: 65862-103

Nonproprietary Name

Amlodipine Besylate

Dosage Form

TABLET

Strength

10 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-103

Substance

AMLODIPINE BESYLATE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2007-07-17

End Marketing Date

-

Listing Record Certified Through

2027-12-31

2017
15 Dec
Drug for Further Processing NDC: 65862-104

Nonproprietary Name

Efavirenz

Dosage Form

CAPSULE

Strength

50 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-104

Substance

EFAVIRENZ

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2017-12-15

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2017
15 Dec
Drug for Further Processing NDC: 65862-105

Nonproprietary Name

Efavirenz

Dosage Form

CAPSULE

Strength

100 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-105

Substance

EFAVIRENZ

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2017-12-15

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2017
15 Dec
Drug for Further Processing NDC: 65862-106

Nonproprietary Name

Efavirenz

Dosage Form

CAPSULE

Strength

200 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-106

Substance

EFAVIRENZ

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2017-12-15

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2006
27 Mar
Drug for Further Processing NDC: 65862-107

Nonproprietary Name

Zidovudine

Dosage Form

CAPSULE

Strength

100 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-107

Substance

ZIDOVUDINE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2006-03-27

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2007
19 Sep
Drug for Further Processing NDC: 65862-113

Nonproprietary Name

Hydrochlorothiazide

Dosage Form

CAPSULE

Strength

12.5 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-113

Substance

HYDROCHLOROTHIAZIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2007-09-19

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2008
22 May
Drug for Further Processing NDC: 65862-117

Nonproprietary Name

Benazepril Hydrochloride

Dosage Form

TABLET, FILM COATED

Strength

20 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-117

Substance

BENAZEPRIL HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2008-05-22

End Marketing Date

2026-11-30

Listing Record Certified Through

-

2008
22 May
Drug for Further Processing NDC: 65862-118

Nonproprietary Name

Benazepril Hydrochloride

Dosage Form

TABLET, FILM COATED

Strength

40 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-118

Substance

BENAZEPRIL HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2008-05-22

End Marketing Date

2026-11-30

Listing Record Certified Through

-

2007
17 Oct
Drug for Further Processing NDC: 65862-125

Nonproprietary Name

Torsemide

Dosage Form

TABLET

Strength

5 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-125

Substance

TORSEMIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2007-10-17

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2007
17 Oct
Drug for Further Processing NDC: 65862-126

Nonproprietary Name

Torsemide

Dosage Form

TABLET

Strength

10 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-126

Substance

TORSEMIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2007-10-17

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2007
17 Oct
Drug for Further Processing NDC: 65862-127

Nonproprietary Name

Torsemide

Dosage Form

TABLET

Strength

20 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-127

Substance

TORSEMIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2007-10-17

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2007
17 Oct
Drug for Further Processing NDC: 65862-128

Nonproprietary Name

Torsemide

Dosage Form

TABLET

Strength

100 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-128

Substance

TORSEMIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2007-10-17

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2007
20 Jul
Drug for Further Processing NDC: 65862-133

Nonproprietary Name

Hydrochlorothiazide

Dosage Form

TABLET

Strength

25 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-133

Substance

HYDROCHLOROTHIAZIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2007-07-20

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2007
20 Jul
Drug for Further Processing NDC: 65862-134

Nonproprietary Name

Hydrochlorothiazide

Dosage Form

TABLET

Strength

50 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-134

Substance

HYDROCHLOROTHIAZIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2007-07-20

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2007
05 Sep
Drug for Further Processing NDC: 65862-142

Nonproprietary Name

Carvedilol

Dosage Form

TABLET, FILM COATED

Strength

3.125 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-142

Substance

CARVEDILOL

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2007-09-05

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2007
05 Sep
Drug for Further Processing NDC: 65862-143

Nonproprietary Name

Carvedilol

Dosage Form

TABLET, FILM COATED

Strength

6.25 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-143

Substance

CARVEDILOL

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2007-09-05

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2007
05 Sep
Drug for Further Processing NDC: 65862-144

Nonproprietary Name

Carvedilol

Dosage Form

TABLET, FILM COATED

Strength

12.5 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-144

Substance

CARVEDILOL

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2007-09-05

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2007
05 Sep
Drug for Further Processing NDC: 65862-145

Nonproprietary Name

Carvedilol

Dosage Form

TABLET, FILM COATED

Strength

25 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-145

Substance

CARVEDILOL

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2007-09-05

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2009
17 Aug
Drug for Further Processing NDC: 65862-146

Nonproprietary Name

Sumatriptan Succinate

Dosage Form

TABLET

Strength

25 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-146

Substance

SUMATRIPTAN SUCCINATE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2009-08-17

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2009
17 Aug
Drug for Further Processing NDC: 65862-147

Nonproprietary Name

Sumatriptan Succinate

Dosage Form

TABLET

Strength

50 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-147

Substance

SUMATRIPTAN SUCCINATE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2009-08-17

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2009
17 Aug
Drug for Further Processing NDC: 65862-148

Nonproprietary Name

Sumatriptan Succinate

Dosage Form

TABLET

Strength

100 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-148

Substance

SUMATRIPTAN SUCCINATE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2009-08-17

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2007
30 Oct
Drug for Further Processing NDC: 65862-149

Nonproprietary Name

Finasteride

Dosage Form

TABLET, FILM COATED

Strength

5 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-149

Substance

FINASTERIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2007-10-30

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2007
25 Jul
Drug for Further Processing NDC: 65862-154

Nonproprietary Name

Paroxetine Hydrochloride

Dosage Form

TABLET, FILM COATED

Strength

10 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-154

Substance

PAROXETINE HYDROCHLORIDE HEMIHYDRATE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2007-07-25

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2007
25 Jul
Drug for Further Processing NDC: 65862-155

Nonproprietary Name

Paroxetine Hydrochloride

Dosage Form

TABLET, FILM COATED

Strength

20 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-155

Substance

PAROXETINE HYDROCHLORIDE HEMIHYDRATE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2007-07-25

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2007
25 Jul
Drug for Further Processing NDC: 65862-156

Nonproprietary Name

Paroxetine Hydrochloride

Dosage Form

TABLET, FILM COATED

Strength

30 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-156

Substance

PAROXETINE HYDROCHLORIDE HEMIHYDRATE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2007-07-25

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2007
25 Jul
Drug for Further Processing NDC: 65862-157

Nonproprietary Name

Paroxetine Hydrochloride

Dosage Form

TABLET, FILM COATED

Strength

40 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-157

Substance

PAROXETINE HYDROCHLORIDE HEMIHYDRATE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2007-07-25

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2009
06 Aug
Drug for Further Processing NDC: 65862-158

Nonproprietary Name

carisoprodol

Dosage Form

TABLET

Strength

350 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-158

Substance

CARISOPRODOL

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

CIV

Start Marketing Date

2009-08-06

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2007
04 May
Drug for Further Processing NDC: 65862-159

Nonproprietary Name

Zolpidem Tartrate

Dosage Form

TABLET, FILM COATED

Strength

5 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-159

Substance

ZOLPIDEM TARTRATE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

CIV

Start Marketing Date

2007-05-04

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2007
04 May
Drug for Further Processing NDC: 65862-160

Nonproprietary Name

Zolpidem Tartrate

Dosage Form

TABLET, FILM COATED

Strength

10 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-160

Substance

ZOLPIDEM TARTRATE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

CIV

Start Marketing Date

2007-05-04

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2007
24 Aug
Drug for Further Processing NDC: 65862-161

Nonproprietary Name

Quinapril Hydrochloride/Hydrochlorothiazide

Dosage Form

TABLET, FILM COATED

Strength

12.5; 10 mg/1; mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-161

Substance

HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2007-08-24

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2007
24 Aug
Drug for Further Processing NDC: 65862-162

Nonproprietary Name

Quinapril Hydrochloride/Hydrochlorothiazide

Dosage Form

TABLET, FILM COATED

Strength

12.5; 20 mg/1; mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-162

Substance

HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2007-08-24

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2007
24 Aug
Drug for Further Processing NDC: 65862-163

Nonproprietary Name

Quinapril Hydrochloride/Hydrochlorothiazide

Dosage Form

TABLET, FILM COATED

Strength

25; 20 mg/1; mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-163

Substance

HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2007-08-24

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2007
12 Jun
Drug for Further Processing NDC: 65862-164

Nonproprietary Name

Trandolapril

Dosage Form

TABLET

Strength

1 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-164

Substance

TRANDOLAPRIL

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2007-06-12

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2007
12 Jun
Drug for Further Processing NDC: 65862-165

Nonproprietary Name

Trandolapril

Dosage Form

TABLET

Strength

2 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-165

Substance

TRANDOLAPRIL

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2007-06-12

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2007
12 Jun
Drug for Further Processing NDC: 65862-166

Nonproprietary Name

Trandolapril

Dosage Form

TABLET

Strength

4 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-166

Substance

TRANDOLAPRIL

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2007-06-12

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2007
31 Oct
Drug for Further Processing NDC: 65862-168

Nonproprietary Name

Atenolol

Dosage Form

TABLET

Strength

25 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-168

Substance

ATENOLOL

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2007-10-31

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2007
31 Oct
Drug for Further Processing NDC: 65862-169

Nonproprietary Name

Atenolol

Dosage Form

TABLET

Strength

50 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-169

Substance

ATENOLOL

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2007-10-31

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2007
31 Oct
Drug for Further Processing NDC: 65862-170

Nonproprietary Name

Atenolol

Dosage Form

TABLET

Strength

100 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-170

Substance

ATENOLOL

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2007-10-31

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2009
27 Mar
Drug for Further Processing NDC: 65862-171

Nonproprietary Name

Topiramate

Dosage Form

TABLET, FILM COATED

Strength

25 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-171

Substance

TOPIRAMATE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2009-03-27

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2009
27 Mar
Drug for Further Processing NDC: 65862-172

Nonproprietary Name

Topiramate

Dosage Form

TABLET, FILM COATED

Strength

50 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-172

Substance

TOPIRAMATE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2009-03-27

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2009
27 Mar
Drug for Further Processing NDC: 65862-173

Nonproprietary Name

Topiramate

Dosage Form

TABLET, FILM COATED

Strength

100 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-173

Substance

TOPIRAMATE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2009-03-27

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2009
27 Mar
Drug for Further Processing NDC: 65862-174

Nonproprietary Name

Topiramate

Dosage Form

TABLET, FILM COATED

Strength

200 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-174

Substance

TOPIRAMATE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2009-03-27

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2008
29 Apr
Drug for Further Processing NDC: 65862-175

Nonproprietary Name

Penicillin V Potassium

Dosage Form

TABLET, FILM COATED

Strength

250 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-175

Substance

PENICILLIN V POTASSIUM

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2008-04-29

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2008
29 Apr
Drug for Further Processing NDC: 65862-176

Nonproprietary Name

Penicillin V Potassium

Dosage Form

TABLET, FILM COATED

Strength

500 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-176

Substance

PENICILLIN V POTASSIUM

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2008-04-29

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2008
07 Jan
Drug for Further Processing NDC: 65862-177

Nonproprietary Name

cefdinir

Dosage Form

CAPSULE

Strength

300 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-177

Substance

CEFDINIR

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2008-01-07

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2009
26 Aug
Drug for Further Processing NDC: 65862-185

Nonproprietary Name

Clindamycin Hydrochloride

Dosage Form

CAPSULE

Strength

150 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-185

Substance

CLINDAMYCIN HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2009-08-26

End Marketing Date

-

Listing Record Certified Through

2027-12-31

2009
26 Aug
Drug for Further Processing NDC: 65862-186

Nonproprietary Name

Clindamycin Hydrochloride

Dosage Form

CAPSULE

Strength

300 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-186

Substance

CLINDAMYCIN HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2009-08-26

End Marketing Date

-

Listing Record Certified Through

2027-12-31

2007
31 Jul
Drug for Further Processing NDC: 65862-187

Nonproprietary Name

Ondansetron Hydrochloride

Dosage Form

TABLET, FILM COATED

Strength

4 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-187

Substance

ONDANSETRON HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2007-07-31

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2007
31 Jul
Drug for Further Processing NDC: 65862-188

Nonproprietary Name

Ondansetron Hydrochloride

Dosage Form

TABLET, FILM COATED

Strength

8 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-188

Substance

ONDANSETRON HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2007-07-31

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2007
31 Jul
Drug for Further Processing NDC: 65862-189

Nonproprietary Name

Ondansetron Hydrochloride

Dosage Form

TABLET, FILM COATED

Strength

24 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-189

Substance

ONDANSETRON HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2007-07-31

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2008
26 Sep
Drug for Further Processing NDC: 65862-190

Nonproprietary Name

Cyclobenzaprine Hydrochloride

Dosage Form

TABLET, FILM COATED

Strength

5 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-190

Substance

CYCLOBENZAPRINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2008-09-26

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2008
26 Sep
Drug for Further Processing NDC: 65862-191

Nonproprietary Name

Cyclobenzaprine Hydrochloride

Dosage Form

TABLET, FILM COATED

Strength

10 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-191

Substance

CYCLOBENZAPRINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2008-09-26

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2008
31 Jan
Drug for Further Processing NDC: 65862-192

Nonproprietary Name

Fluoxetine Hydrochloride

Dosage Form

CAPSULE

Strength

10 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-192

Substance

FLUOXETINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2008-01-31

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2008
31 Jan
Drug for Further Processing NDC: 65862-193

Nonproprietary Name

Fluoxetine Hydrochloride

Dosage Form

CAPSULE

Strength

20 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-193

Substance

FLUOXETINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2008-01-31

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2008
31 Jan
Drug for Further Processing NDC: 65862-194

Nonproprietary Name

Fluoxetine Hydrochloride

Dosage Form

CAPSULE

Strength

40 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-194

Substance

FLUOXETINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2008-01-31

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
11 Jan
Bulk Ingredient NDC: 65862-197

Nonproprietary Name

Zaleplon

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-197

Substance

ZALEPLON

Product Type

BULK INGREDIENT

DEA Schedule

CIV

Start Marketing Date

2024-01-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2008
31 Jan
Drug for Further Processing NDC: 65862-198

Nonproprietary Name

Gabapentin

Dosage Form

CAPSULE

Strength

100 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-198

Substance

GABAPENTIN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2008-01-31

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2008
31 Jan
Drug for Further Processing NDC: 65862-199

Nonproprietary Name

Gabapentin

Dosage Form

CAPSULE

Strength

300 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-199

Substance

GABAPENTIN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2008-01-31

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2008
31 Jan
Drug for Further Processing NDC: 65862-200

Nonproprietary Name

Gabapentin

Dosage Form

CAPSULE

Strength

400 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-200

Substance

GABAPENTIN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2008-01-31

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2010
06 Oct
Drug for Further Processing NDC: 65862-201

Nonproprietary Name

Losartan Potassium

Dosage Form

TABLET, FILM COATED

Strength

25 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-201

Substance

LOSARTAN POTASSIUM

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2010-10-06

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2010
06 Oct
Drug for Further Processing NDC: 65862-202

Nonproprietary Name

Losartan Potassium

Dosage Form

TABLET, FILM COATED

Strength

50 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-202

Substance

LOSARTAN POTASSIUM

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2010-10-06

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2010
06 Oct
Drug for Further Processing NDC: 65862-203

Nonproprietary Name

Losartan Potassium

Dosage Form

TABLET, FILM COATED

Strength

100 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-203

Substance

LOSARTAN POTASSIUM

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2010-10-06

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
05 Jan
Bulk Ingredient NDC: 65862-204

Nonproprietary Name

Doxazosin Mesylate

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-204

Substance

DOXAZOSIN MESYLATE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-05

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
15 Nov
Bulk Ingredient NDC: 65862-205

Nonproprietary Name

Terazosin Hydrochloride

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-205

Substance

TERAZOSIN HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-11-15

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
15 Dec
Bulk Ingredient NDC: 65862-206

Nonproprietary Name

Alfuzosin Hydrochloride

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-206

Substance

ALFUZOSIN HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-12-15

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2009
17 Sep
Drug for Further Processing NDC: 65862-207

Nonproprietary Name

Ribavirin

Dosage Form

TABLET, FILM COATED

Strength

200 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-207

Substance

RIBAVIRIN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2009-09-17

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2008
11 Mar
Drug for Further Processing NDC: 65862-209

Nonproprietary Name

Minocycline Hydrochloride

Dosage Form

CAPSULE

Strength

50 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-209

Substance

MINOCYCLINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2008-03-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2008
11 Mar
Drug for Further Processing NDC: 65862-210

Nonproprietary Name

Minocycline Hydrochloride

Dosage Form

CAPSULE

Strength

75 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-210

Substance

MINOCYCLINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2008-03-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2008
11 Mar
Drug for Further Processing NDC: 65862-211

Nonproprietary Name

Minocycline Hydrochloride

Dosage Form

CAPSULE

Strength

100 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-211

Substance

MINOCYCLINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2008-03-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
10 Jan
Bulk Ingredient NDC: 65862-212

Nonproprietary Name

Cephapirin Benzathine

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-212

Substance

CEPHAPIRIN BENZATHINE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-10

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2008
06 Jun
Drug for Further Processing NDC: 65862-214

Nonproprietary Name

ZALEPLON

Dosage Form

CAPSULE

Strength

5 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-214

Substance

ZALEPLON

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

CIV

Start Marketing Date

2008-06-06

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2008
06 Jun
Drug for Further Processing NDC: 65862-215

Nonproprietary Name

ZALEPLON

Dosage Form

CAPSULE

Strength

10 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-215

Substance

ZALEPLON

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

CIV

Start Marketing Date

2008-06-06

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
04 Nov
Bulk Ingredient NDC: 65862-220

Nonproprietary Name

Metformin Hydrochloride

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-220

Substance

METFORMIN HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-11-04

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
11 Jan
Bulk Ingredient NDC: 65862-221

Nonproprietary Name

Simvastatin

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-221

Substance

SIMVASTATIN

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
17 Jan
Bulk Ingredient NDC: 65862-222

Nonproprietary Name

Sertraline Hydrochloride

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-222

Substance

SERTRALINE HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-17

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
15 Nov
Bulk Ingredient NDC: 65862-223

Nonproprietary Name

Meloxicam

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-223

Substance

MELOXICAM

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-11-15

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2012
25 Jul
Drug for Further Processing NDC: 65862-225

Nonproprietary Name

Clarithromycin

Dosage Form

TABLET, FILM COATED

Strength

250 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-225

Substance

CLARITHROMYCIN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2012-07-25

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2012
25 Jul
Drug for Further Processing NDC: 65862-226

Nonproprietary Name

Clarithromycin

Dosage Form

TABLET, FILM COATED

Strength

500 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-226

Substance

CLARITHROMYCIN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2012-07-25

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2009
27 Jan
Drug for Further Processing NDC: 65862-227

Nonproprietary Name

Lamotrigine

Dosage Form

TABLET

Strength

25 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-227

Substance

LAMOTRIGINE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2009-01-27

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2009
27 Jan
Drug for Further Processing NDC: 65862-228

Nonproprietary Name

Lamotrigine

Dosage Form

TABLET

Strength

100 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-228

Substance

LAMOTRIGINE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2009-01-27

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2009
27 Jan
Drug for Further Processing NDC: 65862-229

Nonproprietary Name

Lamotrigine

Dosage Form

TABLET

Strength

150 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-229

Substance

LAMOTRIGINE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2009-01-27

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2009
27 Jan
Drug for Further Processing NDC: 65862-230

Nonproprietary Name

Lamotrigine

Dosage Form

TABLET

Strength

200 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-230

Substance

LAMOTRIGINE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2009-01-27

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2016
11 Mar
Drug for Further Processing NDC: 65862-237

Nonproprietary Name

Ibandronate Sodium

Dosage Form

TABLET, FILM COATED

Strength

150 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-237

Substance

IBANDRONATE SODIUM

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2016-03-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2017
30 May
Drug for Further Processing NDC: 65862-238

Nonproprietary Name

Atomoxetine

Dosage Form

CAPSULE

Strength

10 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-238

Substance

ATOMOXETINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2017-05-30

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2017
30 May
Drug for Further Processing NDC: 65862-239

Nonproprietary Name

Atomoxetine

Dosage Form

CAPSULE

Strength

18 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-239

Substance

ATOMOXETINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2017-05-30

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2017
30 May
Drug for Further Processing NDC: 65862-240

Nonproprietary Name

Atomoxetine

Dosage Form

CAPSULE

Strength

25 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-240

Substance

ATOMOXETINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2017-05-30

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2017
30 May
Drug for Further Processing NDC: 65862-241

Nonproprietary Name

Atomoxetine

Dosage Form

CAPSULE

Strength

40 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-241

Substance

ATOMOXETINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2017-05-30

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2017
30 May
Drug for Further Processing NDC: 65862-242

Nonproprietary Name

Atomoxetine

Dosage Form

CAPSULE

Strength

60 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-242

Substance

ATOMOXETINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2017-05-30

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2017
30 May
Drug for Further Processing NDC: 65862-243

Nonproprietary Name

Atomoxetine

Dosage Form

CAPSULE

Strength

80 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-243

Substance

ATOMOXETINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2017-05-30

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2017
30 May
Drug for Further Processing NDC: 65862-244

Nonproprietary Name

Atomoxetine

Dosage Form

CAPSULE

Strength

100 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-244

Substance

ATOMOXETINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2017-05-30

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2009
15 Jan
Drug for Further Processing NDC: 65862-245

Nonproprietary Name

Levetiracetam

Dosage Form

TABLET, FILM COATED

Strength

250 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-245

Substance

LEVETIRACETAM

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2009-01-15

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2009
15 Jan
Drug for Further Processing NDC: 65862-246

Nonproprietary Name

Levetiracetam

Dosage Form

TABLET, FILM COATED

Strength

500 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-246

Substance

LEVETIRACETAM

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2009-01-15

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2009
15 Jan
Drug for Further Processing NDC: 65862-247

Nonproprietary Name

Levetiracetam

Dosage Form

TABLET, FILM COATED

Strength

750 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-247

Substance

LEVETIRACETAM

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2009-01-15

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2012
30 Aug
Drug for Further Processing NDC: 65862-249

Nonproprietary Name

Alfuzosin Hydrochloride

Dosage Form

TABLET, FILM COATED, EXTENDED RELEASE

Strength

10 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-249

Substance

ALFUZOSIN HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2012-08-30

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
11 Jan
Bulk Ingredient NDC: 65862-256

Nonproprietary Name

Abacavir Sulfate

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-256

Substance

ABACAVIR SULFATE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
16 Jan
Bulk Ingredient NDC: 65862-257

Nonproprietary Name

Nevirapine Anhydrous

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-257

Substance

NEVIRAPINE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-16

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
12 Jan
Bulk Ingredient NDC: 65862-258

Nonproprietary Name

Zidovudine

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-258

Substance

ZIDOVUDINE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-12

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
09 Jan
Bulk Ingredient NDC: 65862-259

Nonproprietary Name

Lamivudine

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-259

Substance

LAMIVUDINE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-09

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
11 Jan
Bulk Ingredient NDC: 65862-260

Nonproprietary Name

Carisoprodol

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-260

Substance

CARISOPRODOL

Product Type

BULK INGREDIENT

DEA Schedule

CIV

Start Marketing Date

2024-01-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
15 Nov
Bulk Ingredient NDC: 65862-261

Nonproprietary Name

Levetiracetam

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-261

Substance

LEVETIRACETAM

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-11-15

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
12 Jan
Bulk Ingredient NDC: 65862-262

Nonproprietary Name

Quetiapine Fumarate

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-262

Substance

QUETIAPINE FUMARATE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-12

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
16 Jan
Bulk Ingredient NDC: 65862-263

Nonproprietary Name

Stavudine

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-263

Substance

STAVUDINE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-16

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
11 Jan
Bulk Ingredient NDC: 65862-265

Nonproprietary Name

Lopinavir

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-265

Substance

LOPINAVIR

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
07 Dec
Bulk Ingredient NDC: 65862-266

Nonproprietary Name

Lamotrigine

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-266

Substance

LAMOTRIGINE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-12-07

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
11 Jan
Bulk Ingredient NDC: 65862-267

Nonproprietary Name

Efavirenz

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-267

Substance

EFAVIRENZ

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
11 Jan
Bulk Ingredient NDC: 65862-268

Nonproprietary Name

Alendronate Sodium

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-268

Substance

ALENDRONATE SODIUM

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
11 Jan
Bulk Ingredient NDC: 65862-269

Nonproprietary Name

Atomoxetine Hydrochloride

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-269

Substance

ATOMOXETINE HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
08 Jan
Bulk Ingredient NDC: 65862-270

Nonproprietary Name

Ibandronate Sodium

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-270

Substance

IBANDRONATE SODIUM

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-08

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
16 Jan
Bulk Ingredient NDC: 65862-274

Nonproprietary Name

Amoxicillin

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-274

Substance

AMOXICILLIN

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-16

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
16 Jan
Bulk Ingredient NDC: 65862-275

Nonproprietary Name

Ampicillin Trihydrate

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-275

Substance

AMPICILLIN TRIHYDRATE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-16

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
16 Jan
Bulk Ingredient NDC: 65862-276

Nonproprietary Name

Oxacillin Sodium

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-276

Substance

OXACILLIN SODIUM

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-16

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
17 Jan
Bulk Ingredient NDC: 65862-277

Nonproprietary Name

Piperacillin

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-277

Substance

PIPERACILLIN

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-17

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
12 Jan
Bulk Ingredient NDC: 65862-278

Nonproprietary Name

Dicloxacillin Sodium

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-278

Substance

DICLOXACILLIN SODIUM

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-12

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
16 Nov
Bulk Ingredient NDC: 65862-279

Nonproprietary Name

Sulbactam Sodium

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-279

Substance

SULBACTAM SODIUM

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-11-16

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
17 Jan
Bulk Ingredient NDC: 65862-280

Nonproprietary Name

Tazobactam Hemihydrate

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-280

Substance

TAZOBACTAM HEMIHYDRATE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-17

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
16 Nov
Bulk Ingredient NDC: 65862-282

Nonproprietary Name

Ampicillin Sodium (Sterile)

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-282

Substance

AMPICILLIN SODIUM

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-11-16

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
02 Nov
Bulk Ingredient NDC: 65862-283

Nonproprietary Name

Ampicillin and Sulbactam for Injection

Dosage Form

POWDER

Strength

33.25; 16.75 kg/50kg; kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING

65862-283

Substance

AMPICILLIN SODIUM; SULBACTAM SODIUM

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-11-02

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
17 Jan
Bulk Ingredient NDC: 65862-285

Nonproprietary Name

Sulbactam Sodium

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-285

Substance

SULBACTAM SODIUM

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-17

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2009
10 Nov
Drug for Further Processing NDC: 65862-286

Nonproprietary Name

Perindopril Erbumine

Dosage Form

TABLET

Strength

2 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-286

Substance

PERINDOPRIL ERBUMINE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2009-11-10

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2009
10 Nov
Drug for Further Processing NDC: 65862-287

Nonproprietary Name

Perindopril Erbumine

Dosage Form

TABLET

Strength

4 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-287

Substance

PERINDOPRIL ERBUMINE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2009-11-10

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2009
10 Nov
Drug for Further Processing NDC: 65862-288

Nonproprietary Name

Perindopril Erbumine

Dosage Form

TABLET

Strength

8 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-288

Substance

PERINDOPRIL ERBUMINE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2009-11-10

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2009
17 Sep
Drug for Further Processing NDC: 65862-290

Nonproprietary Name

Ribavirin

Dosage Form

CAPSULE

Strength

200 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-290

Substance

RIBAVIRIN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2009-09-17

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2016
19 Jul
Drug for Further Processing NDC: 65862-293

Nonproprietary Name

Rosuvastatin Calcium

Dosage Form

TABLET, FILM COATED

Strength

5 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-293

Substance

ROSUVASTATIN CALCIUM

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2016-07-19

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2016
19 Jul
Drug for Further Processing NDC: 65862-294

Nonproprietary Name

Rosuvastatin Calcium

Dosage Form

TABLET, FILM COATED

Strength

10 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-294

Substance

ROSUVASTATIN CALCIUM

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2016-07-19

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2016
19 Jul
Drug for Further Processing NDC: 65862-295

Nonproprietary Name

Rosuvastatin Calcium

Dosage Form

TABLET, FILM COATED

Strength

20 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-295

Substance

ROSUVASTATIN CALCIUM

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2016-07-19

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2016
19 Jul
Drug for Further Processing NDC: 65862-296

Nonproprietary Name

Rosuvastatin Calcium

Dosage Form

TABLET, FILM COATED

Strength

40 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-296

Substance

ROSUVASTATIN CALCIUM

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2016-07-19

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
12 Dec
Bulk Ingredient NDC: 65862-297

Nonproprietary Name

Fluconazole

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-297

Substance

FLUCONAZOLE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-12-12

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
17 Jan
Bulk Ingredient NDC: 65862-298

Nonproprietary Name

Tamsulosin Hydrochloride

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-298

Substance

TAMSULOSIN HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-17

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
15 Mar
Drug for Further Processing NDC: 65862-301

Nonproprietary Name

Emtricitabine

Dosage Form

CAPSULE

Strength

200 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-301

Substance

EMTRICITABINE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2023-03-15

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
11 Jan
Bulk Ingredient NDC: 65862-304

Nonproprietary Name

Rosuvastatin Calcium

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-304

Substance

ROSUVASTATIN CALCIUM

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
11 Jan
Bulk Ingredient NDC: 65862-305

Nonproprietary Name

Emtricitabine

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-305

Substance

EMTRICITABINE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2009
09 Jul
Drug for Further Processing NDC: 65862-308

Nonproprietary Name

Fosinopril Sodium and Hydrochlorothiazide

Dosage Form

TABLET

Strength

10; 12.5 mg/1; mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-308

Substance

FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2009-07-09

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2009
09 Jul
Drug for Further Processing NDC: 65862-309

Nonproprietary Name

Fosinopril Sodium and Hydrochlorothiazide

Dosage Form

TABLET

Strength

20; 12.5 mg/1; mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-309

Substance

FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2009-07-09

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
06 Nov
Bulk Ingredient NDC: 65862-314

Nonproprietary Name

Ceftiofur Hydrochloride

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-314

Substance

CEFTIOFUR HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-11-06

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2009
15 Jan
Drug for Further Processing NDC: 65862-315

Nonproprietary Name

Levetiracetam

Dosage Form

TABLET, FILM COATED

Strength

1000 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-315

Substance

LEVETIRACETAM

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2009-01-15

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
04 Dec
Bulk Ingredient NDC: 65862-316

Nonproprietary Name

Mirtazapine Anhydrous

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-316

Substance

MIRTAZAPINE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-12-04

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
15 Nov
Bulk Ingredient NDC: 65862-318

Nonproprietary Name

Glyburide

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-318

Substance

GLYBURIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-11-15

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
12 Jan
Bulk Ingredient NDC: 65862-320

Nonproprietary Name

Ramipril

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-320

Substance

RAMIPRIL

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-12

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
16 Jan
Bulk Ingredient NDC: 65862-321

Nonproprietary Name

Zidovudine

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-321

Substance

ZIDOVUDINE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-16

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
16 Jan
Bulk Ingredient NDC: 65862-322

Nonproprietary Name

Didanosine

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-322

Substance

DIDANOSINE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-16

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
07 Dec
Bulk Ingredient NDC: 65862-323

Nonproprietary Name

Hydrochlorothiazide

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-323

Substance

HYDROCHLOROTHIAZIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-12-07

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
12 Jan
Bulk Ingredient NDC: 65862-324

Nonproprietary Name

Efavirenz

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-324

Substance

EFAVIRENZ

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-12

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2011
31 May
Drug for Further Processing NDC: 65862-325

Nonproprietary Name

Donepezil Hydrochloride

Dosage Form

TABLET, FILM COATED

Strength

5 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-325

Substance

DONEPEZIL HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2011-05-31

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2011
31 May
Drug for Further Processing NDC: 65862-326

Nonproprietary Name

Donepezil Hydrochloride

Dosage Form

TABLET, FILM COATED

Strength

10 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-326

Substance

DONEPEZIL HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2011-05-31

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2008
04 Aug
Drug for Further Processing NDC: 65862-327

Nonproprietary Name

Alendronate Sodium

Dosage Form

TABLET

Strength

10 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-327

Substance

ALENDRONATE SODIUM

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2008-08-04

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2008
04 Aug
Drug for Further Processing NDC: 65862-328

Nonproprietary Name

Alendronate Sodium

Dosage Form

TABLET

Strength

35 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-328

Substance

ALENDRONATE SODIUM

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2008-08-04

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2008
04 Aug
Drug for Further Processing NDC: 65862-329

Nonproprietary Name

Alendronate Sodium

Dosage Form

TABLET

Strength

70 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-329

Substance

ALENDRONATE SODIUM

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2008-08-04

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2018
15 Nov
Drug for Further Processing NDC: 65862-335

Nonproprietary Name

abacavir and lamivudine

Dosage Form

TABLET, FILM COATED

Strength

600; 300 mg/1; mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-335

Substance

ABACAVIR SULFATE; LAMIVUDINE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2018-11-15

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
04 Nov
Bulk Ingredient NDC: 65862-336

Nonproprietary Name

Citalopram Hydrobromide

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-336

Substance

CITALOPRAM HYDROBROMIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-11-04

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
05 Jan
Bulk Ingredient NDC: 65862-338

Nonproprietary Name

Cephalexin

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-338

Substance

CEPHALEXIN

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-05

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
12 Jan
Bulk Ingredient NDC: 65862-339

Nonproprietary Name

Cefuroxime Axetil

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-339

Substance

CEFUROXIME AXETIL

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-12

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
12 Jan
Bulk Ingredient NDC: 65862-340

Nonproprietary Name

Nevirapine Anhydrous

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-340

Substance

NEVIRAPINE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-12

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
16 Jan
Bulk Ingredient NDC: 65862-342

Nonproprietary Name

Stavudine

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-342

Substance

STAVUDINE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-16

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
12 Dec
Bulk Ingredient NDC: 65862-344

Nonproprietary Name

Amlodipine Besylate

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-344

Substance

AMLODIPINE BESYLATE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-12-12

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
11 Dec
Bulk Ingredient NDC: 65862-345

Nonproprietary Name

Zolpidem Tartrate

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-345

Substance

ZOLPIDEM TARTRATE

Product Type

BULK INGREDIENT

DEA Schedule

CIV

Start Marketing Date

2023-12-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
25 Dec
Bulk Ingredient NDC: 65862-346

Nonproprietary Name

Benazepril Hydrochloride

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-346

Substance

BENAZEPRIL HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-12-25

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
12 Jan
Bulk Ingredient NDC: 65862-347

Nonproprietary Name

Fluoxetine Hydrochloride

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-347

Substance

FLUOXETINE HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-12

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2021
30 Mar
Drug for Further Processing NDC: 65862-354

Nonproprietary Name

Emtricitabine and Tenofovir Disoproxil Fumarate

Dosage Form

TABLET, FILM COATED

Strength

200; 300 mg/1; mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-354

Substance

EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2021-03-30

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2012
17 May
Drug for Further Processing NDC: 65862-357

Nonproprietary Name

Clopidogrel Bisulfate

Dosage Form

TABLET, FILM COATED

Strength

75 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-357

Substance

CLOPIDOGREL BISULFATE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2012-05-17

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
11 Jan
Bulk Ingredient NDC: 65862-359

Nonproprietary Name

Cefadroxil

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-359

Substance

CEFADROXIL

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
15 Nov
Bulk Ingredient NDC: 65862-364

Nonproprietary Name

Terbinafine Hydrochloride

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-364

Substance

TERBINAFINE HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-11-15

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
14 Nov
Bulk Ingredient NDC: 65862-365

Nonproprietary Name

Risperidone

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-365

Substance

RISPERIDONE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-11-14

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
17 Jan
Bulk Ingredient NDC: 65862-367

Nonproprietary Name

Nevirapine Hemihydrate

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-367

Substance

NEVIRAPINE HEMIHYDRATE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-17

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
18 Dec
Bulk Ingredient NDC: 65862-368

Nonproprietary Name

Quinapril Hydrochloride

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-368

Substance

QUINAPRIL HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-12-18

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
12 Jan
Bulk Ingredient NDC: 65862-369

Nonproprietary Name

Carvedilol

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-369

Substance

CARVEDILOL

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-12

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
15 Dec
Bulk Ingredient NDC: 65862-370

Nonproprietary Name

Finasteride

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-370

Substance

FINASTERIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-12-15

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
12 Jan
Bulk Ingredient NDC: 65862-371

Nonproprietary Name

Sumatriptan Succinate

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-371

Substance

SUMATRIPTAN SUCCINATE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-12

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
17 Jan
Bulk Ingredient NDC: 65862-372

Nonproprietary Name

Clopidogrel Bisulfate

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-372

Substance

CLOPIDOGREL BISULFATE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-17

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
20 Nov
Bulk Ingredient NDC: 65862-377

Nonproprietary Name

Ondansetron Hydrochloride

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-377

Substance

ONDANSETRON HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-11-20

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
11 Jan
Bulk Ingredient NDC: 65862-378

Nonproprietary Name

Cefprozil

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-378

Substance

CEFPROZIL

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
11 Jan
Bulk Ingredient NDC: 65862-379

Nonproprietary Name

Ciprofloxacin Hydrochloride

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-379

Substance

CIPROFLOXACIN HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
15 Nov
Bulk Ingredient NDC: 65862-380

Nonproprietary Name

Bisoprolol Fumarate

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-380

Substance

BISOPROLOL FUMARATE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-11-15

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
05 Jan
Bulk Ingredient NDC: 65862-381

Nonproprietary Name

Cefpodoxime Proxetil

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-381

Substance

CEFPODOXIME PROXETIL

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-05

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
05 Dec
Bulk Ingredient NDC: 65862-382

Nonproprietary Name

Paroxetine Hydrochloride (Hemihydrate)

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-382

Substance

PAROXETINE HYDROCHLORIDE HEMIHYDRATE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-12-05

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
13 Dec
Bulk Ingredient NDC: 65862-383

Nonproprietary Name

Topiramate

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-383

Substance

TOPIRAMATE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-12-13

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
11 Jan
Bulk Ingredient NDC: 65862-384

Nonproprietary Name

Cefdinir

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-384

Substance

CEFDINIR

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
14 Nov
Bulk Ingredient NDC: 65862-385

Nonproprietary Name

Gabapentin

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-385

Substance

GABAPENTIN

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-11-14

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
16 Jan
Bulk Ingredient NDC: 65862-386

Nonproprietary Name

Trandolapril

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-386

Substance

TRANDOLAPRIL

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-16

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
18 Dec
Bulk Ingredient NDC: 65862-393

Nonproprietary Name

Fosinopril Sodium

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-393

Substance

FOSINOPRIL SODIUM

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-12-18

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
10 Jan
Bulk Ingredient NDC: 65862-394

Nonproprietary Name

Tolterodine Tartrate

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-394

Substance

TOLTERODINE TARTRATE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-10

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
09 Jan
Bulk Ingredient NDC: 65862-395

Nonproprietary Name

Omeprazole

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-395

Substance

OMEPRAZOLE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-09

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
10 Jan
Bulk Ingredient NDC: 65862-396

Nonproprietary Name

Risedronate Sodium Hemipentahydrate

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-396

Substance

RISEDRONATE SODIUM HEMI-PENTAHYDRATE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-10

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
17 Jan
Bulk Ingredient NDC: 65862-397

Nonproprietary Name

Tenofovir Disoproxil Fumarate

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-397

Substance

TENOFOVIR DISOPROXIL FUMARATE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-17

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
12 Jan
Bulk Ingredient NDC: 65862-398

Nonproprietary Name

Ziprasidone Hydrochloride

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-398

Substance

ZIPRASIDONE HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-12

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
08 Jan
Bulk Ingredient NDC: 65862-399

Nonproprietary Name

Felodipine

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-399

Substance

FELODIPINE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-08

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
12 Jan
Bulk Ingredient NDC: 65862-400

Nonproprietary Name

Didanosine

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-400

Substance

DIDANOSINE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-12

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
15 Nov
Bulk Ingredient NDC: 65862-409

Nonproprietary Name

Ribavirin

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-409

Substance

RIBAVIRIN

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-11-15

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
10 Jan
Bulk Ingredient NDC: 65862-410

Nonproprietary Name

Ritonavir

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-410

Substance

RITONAVIR

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-10

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
04 Nov
Bulk Ingredient NDC: 65862-411

Nonproprietary Name

Escitalopram Oxalate

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-411

Substance

ESCITALOPRAM OXALATE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-11-04

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
15 Nov
Bulk Ingredient NDC: 65862-413

Nonproprietary Name

Bupropion Hydrochloride

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-413

Substance

BUPROPION HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-11-15

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
11 Jan
Bulk Ingredient NDC: 65862-414

Nonproprietary Name

Rabeprazole Sodium

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-414

Substance

RABEPRAZOLE SODIUM

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
04 Nov
Bulk Ingredient NDC: 65862-415

Nonproprietary Name

Metoprolol Succinate

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-415

Substance

METOPROLOL SUCCINATE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-11-04

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
04 Nov
Bulk Ingredient NDC: 65862-416

Nonproprietary Name

Metoprolol Tartrate

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-416

Substance

METOPROLOL TARTRATE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-11-04

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2010
16 Feb
Drug for Further Processing NDC: 65862-419

Nonproprietary Name

Sulfamethoxazole and Trimethoprim

Dosage Form

TABLET

Strength

400; 80 mg/1; mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-419

Substance

SULFAMETHOXAZOLE; TRIMETHOPRIM

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2010-02-16

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2010
16 Feb
Drug for Further Processing NDC: 65862-420

Nonproprietary Name

Sulfamethoxazole and Trimethoprim

Dosage Form

TABLET

Strength

800; 160 mg/1; mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-420

Substance

SULFAMETHOXAZOLE; TRIMETHOPRIM

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2010-02-16

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2018
26 Jan
Drug for Further Processing NDC: 65862-421

Nonproprietary Name

Tenofovir Disoproxil Fumarate

Dosage Form

TABLET, FILM COATED

Strength

300 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-421

Substance

TENOFOVIR DISOPROXIL FUMARATE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2018-01-26

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
11 Jan
Bulk Ingredient NDC: 65862-424

Nonproprietary Name

Gemfibrozil

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-424

Substance

GEMFIBROZIL

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
05 Dec
Bulk Ingredient NDC: 65862-425

Nonproprietary Name

Perindopril tert-Butylamine

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-425

Substance

PERINDOPRIL ERBUMINE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-12-05

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
04 Nov
Bulk Ingredient NDC: 65862-426

Nonproprietary Name

Pantoprazole Sodium Sesquihydrate

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-426

Substance

PANTOPRAZOLE SODIUM

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-11-04

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
12 Jan
Bulk Ingredient NDC: 65862-428

Nonproprietary Name

Losartan Potassium

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-428

Substance

LOSARTAN POTASSIUM

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-12

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
05 Jan
Bulk Ingredient NDC: 65862-429

Nonproprietary Name

Donepezil Hydrochloride

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-429

Substance

DONEPEZIL HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-05

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2015
05 Aug
Drug for Further Processing NDC: 65862-444

Nonproprietary Name

Cetirizine Hydrochloride

Dosage Form

TABLET

Strength

5 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-444

Substance

CETIRIZINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2015-08-05

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2015
05 Aug
Drug for Further Processing NDC: 65862-445

Nonproprietary Name

Cetirizine Hydrochloride

Dosage Form

TABLET

Strength

10 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-445

Substance

CETIRIZINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2015-08-05

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2015
05 Aug
Drug for Further Processing NDC: 65862-446

Nonproprietary Name

Cetirizine Hydrochloride

Dosage Form

TABLET

Strength

5 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-446

Substance

CETIRIZINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2015-08-05

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2015
05 Aug
Drug for Further Processing NDC: 65862-447

Nonproprietary Name

Cetirizine Hydrochloride

Dosage Form

TABLET

Strength

10 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-447

Substance

CETIRIZINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2015-08-05

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2011
07 Jun
Drug for Further Processing NDC: 65862-454

Nonproprietary Name

Alprazolam

Dosage Form

TABLET, EXTENDED RELEASE

Strength

0.5 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-454

Substance

ALPRAZOLAM

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

CIV

Start Marketing Date

2011-06-07

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2011
07 Jun
Drug for Further Processing NDC: 65862-455

Nonproprietary Name

Alprazolam

Dosage Form

TABLET, EXTENDED RELEASE

Strength

1 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-455

Substance

ALPRAZOLAM

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

CIV

Start Marketing Date

2011-06-07

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2011
07 Jun
Drug for Further Processing NDC: 65862-456

Nonproprietary Name

Alprazolam

Dosage Form

TABLET, EXTENDED RELEASE

Strength

2 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-456

Substance

ALPRAZOLAM

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

CIV

Start Marketing Date

2011-06-07

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2011
07 Jun
Drug for Further Processing NDC: 65862-457

Nonproprietary Name

Alprazolam

Dosage Form

TABLET, EXTENDED RELEASE

Strength

3 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-457

Substance

ALPRAZOLAM

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

CIV

Start Marketing Date

2011-06-07

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2011
29 Mar
Drug for Further Processing NDC: 65862-458

Nonproprietary Name

Galantamine

Dosage Form

TABLET, FILM COATED

Strength

4 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-458

Substance

GALANTAMINE HYDROBROMIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2011-03-29

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2011
29 Mar
Drug for Further Processing NDC: 65862-459

Nonproprietary Name

Galantamine

Dosage Form

TABLET, FILM COATED

Strength

8 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-459

Substance

GALANTAMINE HYDROBROMIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2011-03-29

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2011
29 Mar
Drug for Further Processing NDC: 65862-460

Nonproprietary Name

Galantamine

Dosage Form

TABLET, FILM COATED

Strength

12 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-460

Substance

GALANTAMINE HYDROBROMIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2011-03-29

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
16 Nov
Bulk Ingredient NDC: 65862-461

Nonproprietary Name

Ampicillin Trihydrate

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-461

Substance

AMPICILLIN TRIHYDRATE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-11-16

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
03 Nov
Bulk Ingredient NDC: 65862-462

Nonproprietary Name

Valacyclovir Hydrochloride

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-462

Substance

VALACYCLOVIR HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-11-03

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
06 Nov
Bulk Ingredient NDC: 65862-463

Nonproprietary Name

Duloxetine Hydrochloride

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-463

Substance

DULOXETINE HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-11-06

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2011
21 Mar
Drug for Further Processing NDC: 65862-465

Nonproprietary Name

Famciclovir

Dosage Form

TABLET, FILM COATED

Strength

125 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-465

Substance

FAMCICLOVIR

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2011-03-21

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2011
21 Mar
Drug for Further Processing NDC: 65862-466

Nonproprietary Name

Famciclovir

Dosage Form

TABLET, FILM COATED

Strength

250 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-466

Substance

FAMCICLOVIR

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2011-03-21

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2011
21 Mar
Drug for Further Processing NDC: 65862-467

Nonproprietary Name

Famciclovir

Dosage Form

TABLET, FILM COATED

Strength

500 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-467

Substance

FAMCICLOVIR

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2011-03-21

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2010
06 Oct
Drug for Further Processing NDC: 65862-468

Nonproprietary Name

Losartan Potassium and Hydrochlorothiazide

Dosage Form

TABLET, FILM COATED

Strength

12.5; 50 mg/1; mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-468

Substance

HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2010-10-06

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2010
06 Oct
Drug for Further Processing NDC: 65862-469

Nonproprietary Name

Losartan Potassium and Hydrochlorothiazide

Dosage Form

TABLET, FILM COATED

Strength

12.5; 100 mg/1; mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-469

Substance

HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2010-10-06

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2010
06 Oct
Drug for Further Processing NDC: 65862-470

Nonproprietary Name

Losartan Potassium and Hydrochlorothiazide

Dosage Form

TABLET, FILM COATED

Strength

25; 100 mg/1; mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-470

Substance

HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2010-10-06

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2011
30 Mar
Drug for Further Processing NDC: 65862-471

Nonproprietary Name

Fosinopril Sodium

Dosage Form

TABLET

Strength

10 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-471

Substance

FOSINOPRIL SODIUM

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2011-03-30

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2011
30 Mar
Drug for Further Processing NDC: 65862-472

Nonproprietary Name

Fosinopril Sodium

Dosage Form

TABLET

Strength

20 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-472

Substance

FOSINOPRIL SODIUM

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2011-03-30

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2011
30 Mar
Drug for Further Processing NDC: 65862-473

Nonproprietary Name

Fosinopril Sodium

Dosage Form

TABLET

Strength

40 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-473

Substance

FOSINOPRIL SODIUM

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2011-03-30

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2011
08 Jun
Drug for Further Processing NDC: 65862-474

Nonproprietary Name

Ramipril

Dosage Form

CAPSULE

Strength

1.25 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-474

Substance

RAMIPRIL

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2011-06-08

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2011
08 Jun
Drug for Further Processing NDC: 65862-475

Nonproprietary Name

Ramipril

Dosage Form

CAPSULE

Strength

2.5 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-475

Substance

RAMIPRIL

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2011-06-08

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2011
08 Jun
Drug for Further Processing NDC: 65862-476

Nonproprietary Name

Ramipril

Dosage Form

CAPSULE

Strength

5 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-476

Substance

RAMIPRIL

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2011-06-08

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2011
08 Jun
Drug for Further Processing NDC: 65862-477

Nonproprietary Name

Ramipril

Dosage Form

CAPSULE

Strength

10 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-477

Substance

RAMIPRIL

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2011-06-08

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
19 Jan
Bulk Ingredient NDC: 65862-485

Nonproprietary Name

Ceftiofur Hydrochloride

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-485

Substance

CEFTIOFUR HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-19

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
14 Nov
Bulk Ingredient NDC: 65862-486

Nonproprietary Name

Famciclovir

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-486

Substance

FAMCICLOVIR

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-11-14

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
11 Jan
Bulk Ingredient NDC: 65862-487

Nonproprietary Name

Galantamine Hydrobromide

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-487

Substance

GALANTAMINE HYDROBROMIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
11 Jan
Bulk Ingredient NDC: 65862-488

Nonproprietary Name

Levofloxacin

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-488

Substance

LEVOFLOXACIN

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2012
27 Mar
Drug for Further Processing NDC: 65862-489

Nonproprietary Name

Quetiapine Fumarate

Dosage Form

TABLET, FILM COATED

Strength

25 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-489

Substance

QUETIAPINE FUMARATE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2012-03-27

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2012
27 Mar
Drug for Further Processing NDC: 65862-490

Nonproprietary Name

Quetiapine Fumarate

Dosage Form

TABLET, FILM COATED

Strength

50 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-490

Substance

QUETIAPINE FUMARATE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2012-03-27

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2012
27 Mar
Drug for Further Processing NDC: 65862-491

Nonproprietary Name

Quetiapine Fumarate

Dosage Form

TABLET, FILM COATED

Strength

100 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-491

Substance

QUETIAPINE FUMARATE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2012-03-27

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2012
27 Mar
Drug for Further Processing NDC: 65862-492

Nonproprietary Name

Quetiapine Fumarate

Dosage Form

TABLET, FILM COATED

Strength

150 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-492

Substance

QUETIAPINE FUMARATE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2012-03-27

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2012
27 Mar
Drug for Further Processing NDC: 65862-493

Nonproprietary Name

Quetiapine Fumarate

Dosage Form

TABLET, FILM COATED

Strength

200 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-493

Substance

QUETIAPINE FUMARATE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2012-03-27

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2012
27 Mar
Drug for Further Processing NDC: 65862-494

Nonproprietary Name

Quetiapine Fumarate

Dosage Form

TABLET, FILM COATED

Strength

300 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-494

Substance

QUETIAPINE FUMARATE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2012-03-27

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2012
27 Mar
Drug for Further Processing NDC: 65862-495

Nonproprietary Name

Quetiapine Fumarate

Dosage Form

TABLET, FILM COATED

Strength

400 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-495

Substance

QUETIAPINE FUMARATE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2012-03-27

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2021
30 Mar
Drug for Further Processing NDC: 65862-497

Nonproprietary Name

EFAVIRENZ, EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE

Dosage Form

TABLET, FILM COATED

Strength

600; 200; 300 mg/1; mg/1; mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-497

Substance

EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2021-03-30

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
19 Jan
Bulk Ingredient NDC: 65862-499

Nonproprietary Name

Oxacillin for Injection

Dosage Form

POWDER

Strength

49.02 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING

65862-499

Substance

OXACILLIN SODIUM

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-19

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
20 Jan
Bulk Ingredient NDC: 65862-500

Nonproprietary Name

Nafcillin for Injection

Dosage Form

POWDER

Strength

48 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING

65862-500

Substance

NAFCILLIN SODIUM

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-20

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2012
20 Jan
Drug for Further Processing NDC: 65862-501

Nonproprietary Name

Amoxicillin and Clavulanate Potassium

Dosage Form

TABLET, FILM COATED

Strength

250; 125 mg/1; mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-501

Substance

AMOXICILLIN; CLAVULANATE POTASSIUM

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2012-01-20

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2012
20 Jan
Drug for Further Processing NDC: 65862-502

Nonproprietary Name

Amoxicillin and Clavulanate Potassium

Dosage Form

TABLET, FILM COATED

Strength

500; 125 mg/1; mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-502

Substance

AMOXICILLIN; CLAVULANATE POTASSIUM

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2012-01-20

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2012
20 Jan
Drug for Further Processing NDC: 65862-503

Nonproprietary Name

Amoxicillin and Clavulanate Potassium

Dosage Form

TABLET, FILM COATED

Strength

875; 125 mg/1; mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-503

Substance

AMOXICILLIN; CLAVULANATE POTASSIUM

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2012-01-20

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
13 Dec
Bulk Ingredient NDC: 65862-504

Nonproprietary Name

Sertraline Hydrochloride (Form I)

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-504

Substance

SERTRALINE HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-12-13

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
12 Jan
Bulk Ingredient NDC: 65862-505

Nonproprietary Name

Cefuroxime Axetil

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-505

Substance

CEFUROXIME AXETIL

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-12

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
11 Jan
Bulk Ingredient NDC: 65862-506

Nonproprietary Name

Pramipexole Dihydrochloride

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-506

Substance

PRAMIPEXOLE DIHYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
09 Jan
Bulk Ingredient NDC: 65862-507

Nonproprietary Name

Naproxen Sodium

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-507

Substance

NAPROXEN SODIUM

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-09

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
04 Dec
Bulk Ingredient NDC: 65862-508

Nonproprietary Name

Pioglitazone Hydrochloride

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-508

Substance

PIOGLITAZONE HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-12-04

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2013
13 Feb
Drug for Further Processing NDC: 65862-512

Nonproprietary Name

Pioglitazone Hydrochloride

Dosage Form

TABLET

Strength

15 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-512

Substance

PIOGLITAZONE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2013-02-13

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2013
13 Feb
Drug for Further Processing NDC: 65862-513

Nonproprietary Name

Pioglitazone Hydrochloride

Dosage Form

TABLET

Strength

30 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-513

Substance

PIOGLITAZONE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2013-02-13

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2013
13 Feb
Drug for Further Processing NDC: 65862-514

Nonproprietary Name

Pioglitazone Hydrochloride

Dosage Form

TABLET

Strength

45 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-514

Substance

PIOGLITAZONE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2013-02-13

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2011
31 Oct
Drug for Further Processing NDC: 65862-515

Nonproprietary Name

Naproxen Sodium

Dosage Form

TABLET, FILM COATED

Strength

275 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-515

Substance

NAPROXEN SODIUM

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2011-10-31

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2011
31 Oct
Drug for Further Processing NDC: 65862-516

Nonproprietary Name

Naproxen Sodium

Dosage Form

TABLET, FILM COATED

Strength

550 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-516

Substance

NAPROXEN SODIUM

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2011-10-31

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2015
30 Nov
Drug for Further Processing NDC: 65862-517

Nonproprietary Name

Risedronate Sodium

Dosage Form

TABLET, FILM COATED

Strength

5 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-517

Substance

RISEDRONATE SODIUM

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2015-11-30

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2015
30 Nov
Drug for Further Processing NDC: 65862-518

Nonproprietary Name

Risedronate Sodium

Dosage Form

TABLET, FILM COATED

Strength

30 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-518

Substance

RISEDRONATE SODIUM

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2015-11-30

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2015
30 Nov
Drug for Further Processing NDC: 65862-519

Nonproprietary Name

Risedronate Sodium

Dosage Form

TABLET, FILM COATED

Strength

35 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-519

Substance

RISEDRONATE SODIUM

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2015-11-30

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2011
08 Nov
Drug for Further Processing NDC: 65862-520

Nonproprietary Name

Naproxen

Dosage Form

TABLET

Strength

250 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-520

Substance

NAPROXEN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2011-11-08

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2011
08 Nov
Drug for Further Processing NDC: 65862-521

Nonproprietary Name

Naproxen

Dosage Form

TABLET

Strength

375 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-521

Substance

NAPROXEN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2011-11-08

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2011
08 Nov
Drug for Further Processing NDC: 65862-522

Nonproprietary Name

Naproxen

Dosage Form

TABLET

Strength

500 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-522

Substance

NAPROXEN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2011-11-08

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2011
06 Oct
Drug for Further Processing NDC: 65862-523

Nonproprietary Name

Gabapentin

Dosage Form

TABLET, FILM COATED

Strength

600 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-523

Substance

GABAPENTIN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2011-10-06

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2011
06 Oct
Drug for Further Processing NDC: 65862-524

Nonproprietary Name

Gabapentin

Dosage Form

TABLET, FILM COATED

Strength

800 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-524

Substance

GABAPENTIN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2011-10-06

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2013
13 Feb
Drug for Further Processing NDC: 65862-525

Nonproprietary Name

Pioglitazone Hydrochloride and Metformin Hydrochloride

Dosage Form

TABLET, FILM COATED

Strength

500; 15 mg/1; mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-525

Substance

METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2013-02-13

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2013
13 Feb
Drug for Further Processing NDC: 65862-526

Nonproprietary Name

Pioglitazone Hydrochloride and Metformin Hydrochloride

Dosage Form

TABLET, FILM COATED

Strength

850; 15 mg/1; mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-526

Substance

METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2013-02-13

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2011
01 Jun
Drug for Further Processing NDC: 65862-527

Nonproprietary Name

Venlafaxine Hydrochloride

Dosage Form

CAPSULE, EXTENDED RELEASE

Strength

37.5 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-527

Substance

VENLAFAXINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2011-06-01

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2011
01 Jun
Drug for Further Processing NDC: 65862-528

Nonproprietary Name

Venlafaxine Hydrochloride

Dosage Form

CAPSULE, EXTENDED RELEASE

Strength

75 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-528

Substance

VENLAFAXINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2011-06-01

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
11 Jan
Bulk Ingredient NDC: 65862-530

Nonproprietary Name

irbesartan

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-530

Substance

IRBESARTAN

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
18 Jan
Bulk Ingredient NDC: 65862-531

Nonproprietary Name

Omeprazole Magnesium

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-531

Substance

OMEPRAZOLE MAGNESIUM

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-18

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
10 Jan
Bulk Ingredient NDC: 65862-532

Nonproprietary Name

Repaglinide

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-532

Substance

REPAGLINIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-10

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2011
20 Jun
Drug for Further Processing NDC: 65862-536

Nonproprietary Name

Levofloxacin

Dosage Form

TABLET, FILM COATED

Strength

250 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-536

Substance

LEVOFLOXACIN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2011-06-20

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2011
20 Jun
Drug for Further Processing NDC: 65862-537

Nonproprietary Name

Levofloxacin

Dosage Form

TABLET, FILM COATED

Strength

500 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-537

Substance

LEVOFLOXACIN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2011-06-20

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2011
20 Jun
Drug for Further Processing NDC: 65862-538

Nonproprietary Name

Levofloxacin

Dosage Form

TABLET, FILM COATED

Strength

750 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-538

Substance

LEVOFLOXACIN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2011-06-20

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
16 Jan
Bulk Ingredient NDC: 65862-539

Nonproprietary Name

Torsemide

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-539

Substance

TORSEMIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-16

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
08 Nov
Bulk Ingredient NDC: 65862-545

Nonproprietary Name

Clindamycin Palmitate Hydrochloride

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-545

Substance

CLINDAMYCIN PALMITATE HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-11-08

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
15 Nov
Bulk Ingredient NDC: 65862-546

Nonproprietary Name

Olanzapine

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-546

Substance

OLANZAPINE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-11-15

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2013
21 Mar
Drug for Further Processing NDC: 65862-547

Nonproprietary Name

Valsartan and Hydrochlorothiazide

Dosage Form

TABLET, FILM COATED

Strength

12.5; 80 mg/1; mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-547

Substance

HYDROCHLOROTHIAZIDE; VALSARTAN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2013-03-21

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2013
21 Mar
Drug for Further Processing NDC: 65862-548

Nonproprietary Name

Valsartan and Hydrochlorothiazide

Dosage Form

TABLET, FILM COATED

Strength

12.5; 160 mg/1; mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-548

Substance

HYDROCHLOROTHIAZIDE; VALSARTAN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2013-03-21

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2013
21 Mar
Drug for Further Processing NDC: 65862-549

Nonproprietary Name

Valsartan and Hydrochlorothiazide

Dosage Form

TABLET, FILM COATED

Strength

25; 160 mg/1; mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-549

Substance

HYDROCHLOROTHIAZIDE; VALSARTAN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2013-03-21

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2013
21 Mar
Drug for Further Processing NDC: 65862-550

Nonproprietary Name

Valsartan and Hydrochlorothiazide

Dosage Form

TABLET, FILM COATED

Strength

12.5; 320 mg/1; mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-550

Substance

HYDROCHLOROTHIAZIDE; VALSARTAN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2013-03-21

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2013
21 Mar
Drug for Further Processing NDC: 65862-551

Nonproprietary Name

Valsartan and Hydrochlorothiazide

Dosage Form

TABLET, FILM COATED

Strength

25; 320 mg/1; mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-551

Substance

HYDROCHLOROTHIAZIDE; VALSARTAN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2013-03-21

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2012
19 Nov
Drug for Further Processing NDC: 65862-554

Nonproprietary Name

Minocycline Hydrochloride

Dosage Form

TABLET, FILM COATED, EXTENDED RELEASE

Strength

45 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-554

Substance

MINOCYCLINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2012-11-19

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2018
28 Sep
Drug for Further Processing NDC: 65862-555

Nonproprietary Name

Minocycline Hydrochloride

Dosage Form

TABLET, FILM COATED, EXTENDED RELEASE

Strength

65 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-555

Substance

MINOCYCLINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2018-09-28

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2012
19 Nov
Drug for Further Processing NDC: 65862-556

Nonproprietary Name

Minocycline Hydrochloride

Dosage Form

TABLET, FILM COATED, EXTENDED RELEASE

Strength

90 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-556

Substance

MINOCYCLINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2012-11-19

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2018
28 Sep
Drug for Further Processing NDC: 65862-557

Nonproprietary Name

Minocycline Hydrochloride

Dosage Form

TABLET, FILM COATED, EXTENDED RELEASE

Strength

115 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-557

Substance

MINOCYCLINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2018-09-28

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2012
19 Nov
Drug for Further Processing NDC: 65862-558

Nonproprietary Name

Minocycline Hydrochloride

Dosage Form

TABLET, FILM COATED, EXTENDED RELEASE

Strength

135 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-558

Substance

MINOCYCLINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2012-11-19

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2012
28 Sep
Drug for Further Processing NDC: 65862-559

Nonproprietary Name

Pantoprazole Sodium

Dosage Form

TABLET, DELAYED RELEASE

Strength

20 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-559

Substance

PANTOPRAZOLE SODIUM

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2012-09-28

End Marketing Date

-

Listing Record Certified Through

2027-12-31

2012
28 Sep
Drug for Further Processing NDC: 65862-560

Nonproprietary Name

Pantoprazole Sodium

Dosage Form

TABLET, DELAYED RELEASE

Strength

40 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-560

Substance

PANTOPRAZOLE SODIUM

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2012-09-28

End Marketing Date

-

Listing Record Certified Through

2027-12-31

2012
23 Apr
Drug for Further Processing NDC: 65862-561

Nonproprietary Name

Olanzapine

Dosage Form

TABLET

Strength

2.5 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-561

Substance

OLANZAPINE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2012-04-23

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2012
23 Apr
Drug for Further Processing NDC: 65862-562

Nonproprietary Name

Olanzapine

Dosage Form

TABLET

Strength

5 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-562

Substance

OLANZAPINE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2012-04-23

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2012
23 Apr
Drug for Further Processing NDC: 65862-563

Nonproprietary Name

Olanzapine

Dosage Form

TABLET

Strength

7.5 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-563

Substance

OLANZAPINE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2012-04-23

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2012
23 Apr
Drug for Further Processing NDC: 65862-564

Nonproprietary Name

Olanzapine

Dosage Form

TABLET

Strength

10 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-564

Substance

OLANZAPINE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2012-04-23

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2012
23 Apr
Drug for Further Processing NDC: 65862-565

Nonproprietary Name

Olanzapine

Dosage Form

TABLET

Strength

15 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-565

Substance

OLANZAPINE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2012-04-23

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2012
23 Apr
Drug for Further Processing NDC: 65862-566

Nonproprietary Name

Olanzapine

Dosage Form

TABLET

Strength

20 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-566

Substance

OLANZAPINE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2012-04-23

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2012
03 Aug
Drug for Further Processing NDC: 65862-567

Nonproprietary Name

Montelukast Sodium

Dosage Form

TABLET, CHEWABLE

Strength

4 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-567

Substance

MONTELUKAST SODIUM

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2012-08-03

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2012
03 Aug
Drug for Further Processing NDC: 65862-568

Nonproprietary Name

Montelukast Sodium

Dosage Form

TABLET, CHEWABLE

Strength

5 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-568

Substance

MONTELUKAST SODIUM

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2012-08-03

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2015
05 Jan
Drug for Further Processing NDC: 65862-570

Nonproprietary Name

Valsartan

Dosage Form

TABLET, FILM COATED

Strength

40 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-570

Substance

VALSARTAN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2015-01-05

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2015
05 Jan
Drug for Further Processing NDC: 65862-571

Nonproprietary Name

Valsartan

Dosage Form

TABLET, FILM COATED

Strength

80 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-571

Substance

VALSARTAN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2015-01-05

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2015
05 Jan
Drug for Further Processing NDC: 65862-572

Nonproprietary Name

Valsartan

Dosage Form

TABLET, FILM COATED

Strength

160 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-572

Substance

VALSARTAN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2015-01-05

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2015
05 Jan
Drug for Further Processing NDC: 65862-573

Nonproprietary Name

Valsartan

Dosage Form

TABLET, FILM COATED

Strength

320 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-573

Substance

VALSARTAN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2015-01-05

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2012
03 Aug
Drug for Further Processing NDC: 65862-574

Nonproprietary Name

Montelukast Sodium

Dosage Form

TABLET, FILM COATED

Strength

10 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-574

Substance

MONTELUKAST SODIUM

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2012-08-03

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
03 Nov
Bulk Ingredient NDC: 65862-576

Nonproprietary Name

Modafinil

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-576

Substance

MODAFINIL

Product Type

BULK INGREDIENT

DEA Schedule

CIV

Start Marketing Date

2023-11-03

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
11 Jan
Bulk Ingredient NDC: 65862-577

Nonproprietary Name

Lamivudine

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-577

Substance

LAMIVUDINE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
12 Jan
Bulk Ingredient NDC: 65862-578

Nonproprietary Name

Rizatriptan Benzoate

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-578

Substance

RIZATRIPTAN BENZOATE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-12

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2012
29 Jun
Drug for Further Processing NDC: 65862-579

Nonproprietary Name

Glimepiride

Dosage Form

TABLET

Strength

1 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-579

Substance

GLIMEPIRIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2012-06-29

End Marketing Date

-

Listing Record Certified Through

2027-12-31

2012
29 Jun
Drug for Further Processing NDC: 65862-580

Nonproprietary Name

Glimepiride

Dosage Form

TABLET

Strength

2 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-580

Substance

GLIMEPIRIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2012-06-29

End Marketing Date

-

Listing Record Certified Through

2027-12-31

2012
29 Jun
Drug for Further Processing NDC: 65862-581

Nonproprietary Name

Glimepiride

Dosage Form

TABLET

Strength

4 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-581

Substance

GLIMEPIRIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2012-06-29

End Marketing Date

-

Listing Record Certified Through

2027-12-31

2012
05 Sep
Drug for Further Processing NDC: 65862-582

Nonproprietary Name

Amlodipine and Benazepril Hydrochloride

Dosage Form

CAPSULE

Strength

2.5; 10 mg/1; mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-582

Substance

AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2012-09-05

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2012
05 Sep
Drug for Further Processing NDC: 65862-583

Nonproprietary Name

Amlodipine and Benazepril Hydrochloride

Dosage Form

CAPSULE

Strength

5; 10 mg/1; mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-583

Substance

AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2012-09-05

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2012
05 Sep
Drug for Further Processing NDC: 65862-584

Nonproprietary Name

Amlodipine and Benazepril Hydrochloride

Dosage Form

CAPSULE

Strength

5; 20 mg/1; mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-584

Substance

AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2012-09-05

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2012
05 Sep
Drug for Further Processing NDC: 65862-585

Nonproprietary Name

Amlodipine and Benazepril Hydrochloride

Dosage Form

CAPSULE

Strength

5; 40 mg/1; mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-585

Substance

AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2012-09-05

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2012
05 Sep
Drug for Further Processing NDC: 65862-586

Nonproprietary Name

Amlodipine and Benazepril Hydrochloride

Dosage Form

CAPSULE

Strength

10; 20 mg/1; mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-586

Substance

AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2012-09-05

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2012
05 Sep
Drug for Further Processing NDC: 65862-587

Nonproprietary Name

Amlodipine and Benazepril Hydrochloride

Dosage Form

CAPSULE

Strength

10; 40 mg/1; mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-587

Substance

AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2012-09-05

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2014
02 Jun
Drug for Further Processing NDC: 65862-594

Nonproprietary Name

Divalproex sodium

Dosage Form

TABLET, FILM COATED, EXTENDED RELEASE

Strength

250 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-594

Substance

DIVALPROEX SODIUM

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2014-06-02

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2014
02 Jun
Drug for Further Processing NDC: 65862-595

Nonproprietary Name

Divalproex sodium

Dosage Form

TABLET, FILM COATED, EXTENDED RELEASE

Strength

500 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-595

Substance

DIVALPROEX SODIUM

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2014-06-02

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2013
30 Apr
Drug for Further Processing NDC: 65862-598

Nonproprietary Name

Tamsulosin Hydrochloride

Dosage Form

CAPSULE

Strength

0.4 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-598

Substance

TAMSULOSIN HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2013-04-30

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2012
31 Dec
Drug for Further Processing NDC: 65862-599

Nonproprietary Name

Rizatriptan Benzoate

Dosage Form

TABLET

Strength

5 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-599

Substance

RIZATRIPTAN BENZOATE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2012-12-31

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2012
31 Dec
Drug for Further Processing NDC: 65862-600

Nonproprietary Name

Rizatriptan Benzoate

Dosage Form

TABLET

Strength

10 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-600

Substance

RIZATRIPTAN BENZOATE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2012-12-31

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2012
27 Sep
Drug for Further Processing NDC: 65862-601

Nonproprietary Name

Modafinil

Dosage Form

TABLET

Strength

100 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-601

Substance

MODAFINIL

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

CIV

Start Marketing Date

2012-09-27

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2012
27 Sep
Drug for Further Processing NDC: 65862-602

Nonproprietary Name

Modafinil

Dosage Form

TABLET

Strength

200 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-602

Substance

MODAFINIL

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

CIV

Start Marketing Date

2012-09-27

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2014
04 Mar
Drug for Further Processing NDC: 65862-603

Nonproprietary Name

Moxifloxacin Hydrochloride

Dosage Form

TABLET, FILM COATED

Strength

400 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-603

Substance

MOXIFLOXACIN HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2014-03-04

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2012
26 Oct
Drug for Further Processing NDC: 65862-604

Nonproprietary Name

Pramipexole Dihydrochloride

Dosage Form

TABLET

Strength

0.125 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-604

Substance

PRAMIPEXOLE DIHYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2012-10-26

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2012
26 Oct
Drug for Further Processing NDC: 65862-605

Nonproprietary Name

Pramipexole Dihydrochloride

Dosage Form

TABLET

Strength

0.25 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-605

Substance

PRAMIPEXOLE DIHYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2012-10-26

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2012
26 Oct
Drug for Further Processing NDC: 65862-606

Nonproprietary Name

Pramipexole Dihydrochloride

Dosage Form

TABLET

Strength

0.5 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-606

Substance

PRAMIPEXOLE DIHYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2012-10-26

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2012
26 Oct
Drug for Further Processing NDC: 65862-607

Nonproprietary Name

Pramipexole Dihydrochloride

Dosage Form

TABLET

Strength

0.75 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-607

Substance

PRAMIPEXOLE DIHYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2012-10-26

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2012
26 Oct
Drug for Further Processing NDC: 65862-608

Nonproprietary Name

Pramipexole Dihydrochloride

Dosage Form

TABLET

Strength

1 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-608

Substance

PRAMIPEXOLE DIHYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2012-10-26

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2012
26 Oct
Drug for Further Processing NDC: 65862-609

Nonproprietary Name

Pramipexole Dihydrochloride

Dosage Form

TABLET

Strength

1.5 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-609

Substance

PRAMIPEXOLE DIHYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2012-10-26

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
11 Jan
Bulk Ingredient NDC: 65862-611

Nonproprietary Name

Entacapone

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-611

Substance

ENTACAPONE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
18 Dec
Bulk Ingredient NDC: 65862-612

Nonproprietary Name

Rivastigmine Tartrate

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-612

Substance

RIVASTIGMINE TARTRATE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-12-18

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
12 Jan
Bulk Ingredient NDC: 65862-613

Nonproprietary Name

Tramadol Hydrochloride

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-613

Substance

TRAMADOL HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

CIV

Start Marketing Date

2024-01-12

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2013
29 Apr
Drug for Further Processing NDC: 65862-617

Nonproprietary Name

Quinapril Hydrochloride

Dosage Form

TABLET, FILM COATED

Strength

5 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-617

Substance

QUINAPRIL HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2013-04-29

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2013
29 Apr
Drug for Further Processing NDC: 65862-618

Nonproprietary Name

Quinapril Hydrochloride

Dosage Form

TABLET, FILM COATED

Strength

10 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-618

Substance

QUINAPRIL HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2013-04-29

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2013
29 Apr
Drug for Further Processing NDC: 65862-619

Nonproprietary Name

Quinapril Hydrochloride

Dosage Form

TABLET, FILM COATED

Strength

20 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-619

Substance

QUINAPRIL HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2013-04-29

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2013
29 Apr
Drug for Further Processing NDC: 65862-620

Nonproprietary Name

Quinapril Hydrochloride

Dosage Form

TABLET, FILM COATED

Strength

40 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-620

Substance

QUINAPRIL HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2013-04-29

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2015
08 Jul
Drug for Further Processing NDC: 65862-621

Nonproprietary Name

Flecainide Acetate

Dosage Form

TABLET

Strength

50 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-621

Substance

FLECAINIDE ACETATE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2015-07-08

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2015
08 Jul
Drug for Further Processing NDC: 65862-622

Nonproprietary Name

Flecainide Acetate

Dosage Form

TABLET

Strength

100 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-622

Substance

FLECAINIDE ACETATE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2015-07-08

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2015
08 Jul
Drug for Further Processing NDC: 65862-623

Nonproprietary Name

Flecainide Acetate

Dosage Form

TABLET

Strength

150 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-623

Substance

FLECAINIDE ACETATE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2015-07-08

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2015
16 Sep
Drug for Further Processing NDC: 65862-624

Nonproprietary Name

Gemfibrozil

Dosage Form

TABLET, FILM COATED

Strength

600 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-624

Substance

GEMFIBROZIL

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2015-09-16

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2013
01 Jul
Drug for Further Processing NDC: 65862-625

Nonproprietary Name

Rizatriptan Benzoate

Dosage Form

TABLET, ORALLY DISINTEGRATING

Strength

5 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-625

Substance

RIZATRIPTAN BENZOATE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2013-07-01

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2013
01 Jul
Drug for Further Processing NDC: 65862-626

Nonproprietary Name

Rizatriptan Benzoate

Dosage Form

TABLET, ORALLY DISINTEGRATING

Strength

10 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-626

Substance

RIZATRIPTAN BENZOATE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2013-07-01

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
08 Dec
Bulk Ingredient NDC: 65862-627

Nonproprietary Name

Moxifloxacin Hydrochloride

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-627

Substance

MOXIFLOXACIN HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-12-08

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2013
22 Feb
Drug for Further Processing NDC: 65862-629

Nonproprietary Name

Irbesartan and Hydrochlorothiazide

Dosage Form

TABLET, FILM COATED

Strength

12.5; 150 mg/1; mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-629

Substance

HYDROCHLOROTHIAZIDE; IRBESARTAN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2013-02-22

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2013
22 Feb
Drug for Further Processing NDC: 65862-630

Nonproprietary Name

Irbesartan and Hydrochlorothiazide

Dosage Form

TABLET, FILM COATED

Strength

12.5; 300 mg/1; mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-630

Substance

HYDROCHLOROTHIAZIDE; IRBESARTAN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2013-02-22

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2016
31 Mar
Drug for Further Processing NDC: 65862-631

Nonproprietary Name

Irbesartan and Hydrochlorothiazide

Dosage Form

TABLET, FILM COATED

Strength

25; 300 mg/1; mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-631

Substance

HYDROCHLOROTHIAZIDE; IRBESARTAN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2016-03-31

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2017
02 Feb
Drug for Further Processing NDC: 65862-632

Nonproprietary Name

Pravastatin sodium

Dosage Form

TABLET

Strength

10 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-632

Substance

PRAVASTATIN SODIUM

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2017-02-02

End Marketing Date

-

Listing Record Certified Through

2027-12-31

2017
02 Feb
Drug for Further Processing NDC: 65862-633

Nonproprietary Name

Pravastatin sodium

Dosage Form

TABLET

Strength

20 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-633

Substance

PRAVASTATIN SODIUM

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2017-02-02

End Marketing Date

-

Listing Record Certified Through

2027-12-31

2017
02 Feb
Drug for Further Processing NDC: 65862-634

Nonproprietary Name

Pravastatin sodium

Dosage Form

TABLET

Strength

40 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-634

Substance

PRAVASTATIN SODIUM

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2017-02-02

End Marketing Date

-

Listing Record Certified Through

2027-12-31

2017
02 Feb
Drug for Further Processing NDC: 65862-635

Nonproprietary Name

Pravastatin sodium

Dosage Form

TABLET

Strength

80 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-635

Substance

PRAVASTATIN SODIUM

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2017-02-02

End Marketing Date

-

Listing Record Certified Through

2027-12-31

2024
12 Jan
Bulk Ingredient NDC: 65862-636

Nonproprietary Name

Nevirapine Anhydrous (Process II)

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-636

Substance

NEVIRAPINE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-12

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2012
27 Sep
Drug for Further Processing NDC: 65862-637

Nonproprietary Name

Irbesartan

Dosage Form

TABLET

Strength

75 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-637

Substance

IRBESARTAN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2012-09-27

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2012
27 Sep
Drug for Further Processing NDC: 65862-638

Nonproprietary Name

Irbesartan

Dosage Form

TABLET

Strength

150 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-638

Substance

IRBESARTAN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2012-09-27

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2012
27 Sep
Drug for Further Processing NDC: 65862-639

Nonproprietary Name

Irbesartan

Dosage Form

TABLET

Strength

300 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-639

Substance

IRBESARTAN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2012-09-27

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
17 Jan
Bulk Ingredient NDC: 65862-640

Nonproprietary Name

Valsartan

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-640

Substance

VALSARTAN

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-17

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2020
16 Sep
Drug for Further Processing NDC: 65862-641

Nonproprietary Name

azithromycin

Dosage Form

TABLET, FILM COATED

Strength

250 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-641

Substance

AZITHROMYCIN DIHYDRATE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2020-09-16

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2020
16 Sep
Drug for Further Processing NDC: 65862-642

Nonproprietary Name

azithromycin

Dosage Form

TABLET, FILM COATED

Strength

500 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-642

Substance

AZITHROMYCIN DIHYDRATE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2020-09-16

End Marketing Date

-

Listing Record Certified Through

2027-12-31

2016
25 Mar
Drug for Further Processing NDC: 65862-648

Nonproprietary Name

Rivastigmine Tartrate

Dosage Form

CAPSULE

Strength

1.5 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-648

Substance

RIVASTIGMINE TARTRATE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2016-03-25

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2016
25 Mar
Drug for Further Processing NDC: 65862-649

Nonproprietary Name

Rivastigmine Tartrate

Dosage Form

CAPSULE

Strength

3 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-649

Substance

RIVASTIGMINE TARTRATE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2016-03-25

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2016
25 Mar
Drug for Further Processing NDC: 65862-650

Nonproprietary Name

Rivastigmine Tartrate

Dosage Form

CAPSULE

Strength

4.5 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-650

Substance

RIVASTIGMINE TARTRATE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2016-03-25

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2016
25 Mar
Drug for Further Processing NDC: 65862-651

Nonproprietary Name

Rivastigmine Tartrate

Dosage Form

CAPSULE

Strength

6 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-651

Substance

RIVASTIGMINE TARTRATE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2016-03-25

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2015
13 Oct
Drug for Further Processing NDC: 65862-652

Nonproprietary Name

Memantine Hydrochloride

Dosage Form

TABLET, FILM COATED

Strength

5 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-652

Substance

MEMANTINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2015-10-13

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2015
13 Oct
Drug for Further Processing NDC: 65862-653

Nonproprietary Name

Memantine Hydrochloride

Dosage Form

TABLET, FILM COATED

Strength

10 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-653

Substance

MEMANTINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2015-10-13

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2014
15 May
Drug for Further Processing NDC: 65862-656

Nonproprietary Name

Olanzapine

Dosage Form

TABLET, ORALLY DISINTEGRATING

Strength

5 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-656

Substance

OLANZAPINE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2014-05-15

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2014
15 May
Drug for Further Processing NDC: 65862-657

Nonproprietary Name

Olanzapine

Dosage Form

TABLET, ORALLY DISINTEGRATING

Strength

10 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-657

Substance

OLANZAPINE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2014-05-15

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2014
15 May
Drug for Further Processing NDC: 65862-658

Nonproprietary Name

Olanzapine

Dosage Form

TABLET, ORALLY DISINTEGRATING

Strength

15 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-658

Substance

OLANZAPINE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2014-05-15

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2014
15 May
Drug for Further Processing NDC: 65862-659

Nonproprietary Name

Olanzapine

Dosage Form

TABLET, ORALLY DISINTEGRATING

Strength

20 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-659

Substance

OLANZAPINE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2014-05-15

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2015
08 Oct
Drug for Further Processing NDC: 65862-661

Nonproprietary Name

Aripiprazole

Dosage Form

TABLET

Strength

2 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-661

Substance

ARIPIPRAZOLE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2015-10-08

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2015
08 Oct
Drug for Further Processing NDC: 65862-662

Nonproprietary Name

Aripiprazole

Dosage Form

TABLET

Strength

5 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-662

Substance

ARIPIPRAZOLE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2015-10-08

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2015
08 Oct
Drug for Further Processing NDC: 65862-663

Nonproprietary Name

Aripiprazole

Dosage Form

TABLET

Strength

10 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-663

Substance

ARIPIPRAZOLE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2015-10-08

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2015
08 Oct
Drug for Further Processing NDC: 65862-664

Nonproprietary Name

Aripiprazole

Dosage Form

TABLET

Strength

15 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-664

Substance

ARIPIPRAZOLE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2015-10-08

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2015
08 Oct
Drug for Further Processing NDC: 65862-665

Nonproprietary Name

Aripiprazole

Dosage Form

TABLET

Strength

20 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-665

Substance

ARIPIPRAZOLE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2015-10-08

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2015
08 Oct
Drug for Further Processing NDC: 65862-666

Nonproprietary Name

Aripiprazole

Dosage Form

TABLET

Strength

30 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-666

Substance

ARIPIPRAZOLE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2015-10-08

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2014
22 Jan
Drug for Further Processing NDC: 65862-670

Nonproprietary Name

Repaglinide

Dosage Form

TABLET

Strength

0.5 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-670

Substance

REPAGLINIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2014-01-22

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2014
22 Jan
Drug for Further Processing NDC: 65862-671

Nonproprietary Name

Repaglinide

Dosage Form

TABLET

Strength

1 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-671

Substance

REPAGLINIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2014-01-22

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2014
22 Jan
Drug for Further Processing NDC: 65862-672

Nonproprietary Name

Repaglinide

Dosage Form

TABLET

Strength

2 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-672

Substance

REPAGLINIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2014-01-22

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2013
17 Jan
Drug for Further Processing NDC: 65862-673

Nonproprietary Name

Felodipine

Dosage Form

TABLET, FILM COATED, EXTENDED RELEASE

Strength

2.5 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-673

Substance

FELODIPINE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2013-01-17

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2013
17 Jan
Drug for Further Processing NDC: 65862-674

Nonproprietary Name

Felodipine

Dosage Form

TABLET, FILM COATED, EXTENDED RELEASE

Strength

5 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-674

Substance

FELODIPINE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2013-01-17

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2013
17 Jan
Drug for Further Processing NDC: 65862-675

Nonproprietary Name

Felodipine

Dosage Form

TABLET, FILM COATED, EXTENDED RELEASE

Strength

10 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-675

Substance

FELODIPINE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2013-01-17

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2015
31 Jul
Drug for Further Processing NDC: 65862-676

Nonproprietary Name

Alprazolam

Dosage Form

TABLET

Strength

0.25 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-676

Substance

ALPRAZOLAM

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

CIV

Start Marketing Date

2015-07-31

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2015
31 Jul
Drug for Further Processing NDC: 65862-677

Nonproprietary Name

Alprazolam

Dosage Form

TABLET

Strength

0.5 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-677

Substance

ALPRAZOLAM

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

CIV

Start Marketing Date

2015-07-31

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2015
31 Jul
Drug for Further Processing NDC: 65862-678

Nonproprietary Name

Alprazolam

Dosage Form

TABLET

Strength

1 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-678

Substance

ALPRAZOLAM

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

CIV

Start Marketing Date

2015-07-31

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2015
31 Jul
Drug for Further Processing NDC: 65862-679

Nonproprietary Name

Alprazolam

Dosage Form

TABLET

Strength

2 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-679

Substance

ALPRAZOLAM

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

CIV

Start Marketing Date

2015-07-31

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
14 Nov
Bulk Ingredient NDC: 65862-680

Nonproprietary Name

Aripiprazole

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-680

Substance

ARIPIPRAZOLE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-11-14

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2022
08 Feb
Drug for Further Processing NDC: 65862-687

Nonproprietary Name

RITONAVIR

Dosage Form

TABLET, FILM COATED

Strength

100 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-687

Substance

RITONAVIR

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2022-02-08

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2015
10 Jun
Drug for Further Processing NDC: 65862-692

Nonproprietary Name

Phenytoin Sodium

Dosage Form

CAPSULE

Strength

100 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-692

Substance

PHENYTOIN SODIUM

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2015-06-10

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2016
08 Nov
Drug for Further Processing NDC: 65862-693

Nonproprietary Name

carisoprodol

Dosage Form

TABLET

Strength

250 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-693

Substance

CARISOPRODOL

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

CIV

Start Marketing Date

2016-11-08

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
10 Jan
Bulk Ingredient NDC: 65862-696

Nonproprietary Name

Sildenafil Citrate

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-696

Substance

SILDENAFIL CITRATE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-10

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2011
23 Nov
Drug for Further Processing NDC: 65862-697

Nonproprietary Name

Venlafaxine Hydrochloride

Dosage Form

CAPSULE, EXTENDED RELEASE

Strength

150 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-697

Substance

VENLAFAXINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2011-11-23

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2006
29 Mar
Drug for Further Processing NDC: 65862-698

Nonproprietary Name

Cefuroxime Axetil

Dosage Form

TABLET

Strength

125 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-698

Substance

CEFUROXIME AXETIL

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2006-03-29

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2006
29 Mar
Drug for Further Processing NDC: 65862-699

Nonproprietary Name

Cefuroxime Axetil

Dosage Form

TABLET

Strength

250 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-699

Substance

CEFUROXIME AXETIL

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2006-03-29

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2006
29 Mar
Drug for Further Processing NDC: 65862-700

Nonproprietary Name

Cefuroxime Axetil

Dosage Form

TABLET

Strength

500 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-700

Substance

CEFUROXIME AXETIL

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2006-03-29

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
15 Dec
Bulk Ingredient NDC: 65862-701

Nonproprietary Name

Atazanavir Sulfate

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-701

Substance

ATAZANAVIR SULFATE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-12-15

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2016
27 Dec
Drug for Further Processing NDC: 65862-702

Nonproprietary Name

Ziprasidone Hydrochloride

Dosage Form

CAPSULE

Strength

20 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-702

Substance

ZIPRASIDONE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2016-12-27

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2016
27 Dec
Drug for Further Processing NDC: 65862-703

Nonproprietary Name

Ziprasidone Hydrochloride

Dosage Form

CAPSULE

Strength

40 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-703

Substance

ZIPRASIDONE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2016-12-27

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2016
27 Dec
Drug for Further Processing NDC: 65862-704

Nonproprietary Name

Ziprasidone Hydrochloride

Dosage Form

CAPSULE

Strength

60 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-704

Substance

ZIPRASIDONE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2016-12-27

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2016
27 Dec
Drug for Further Processing NDC: 65862-705

Nonproprietary Name

Ziprasidone Hydrochloride

Dosage Form

CAPSULE

Strength

80 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-705

Substance

ZIPRASIDONE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2016-12-27

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
11 Jan
Bulk Ingredient NDC: 65862-708

Nonproprietary Name

Olmesartan Medoxomil

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-708

Substance

OLMESARTAN MEDOXOMIL

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2015
28 Aug
Drug for Further Processing NDC: 65862-709

Nonproprietary Name

Raloxifene Hydrochloride

Dosage Form

TABLET, FILM COATED

Strength

60 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-709

Substance

RALOXIFENE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2015-08-28

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2018
25 Jun
Drug for Further Processing NDC: 65862-710

Nonproprietary Name

Atazanavir

Dosage Form

CAPSULE

Strength

100 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-710

Substance

ATAZANAVIR SULFATE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2018-06-25

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2018
25 Jun
Drug for Further Processing NDC: 65862-711

Nonproprietary Name

Atazanavir

Dosage Form

CAPSULE

Strength

150 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-711

Substance

ATAZANAVIR SULFATE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2018-06-25

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2018
25 Jun
Drug for Further Processing NDC: 65862-712

Nonproprietary Name

Atazanavir

Dosage Form

CAPSULE

Strength

200 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-712

Substance

ATAZANAVIR SULFATE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2018-06-25

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2018
25 Jun
Drug for Further Processing NDC: 65862-713

Nonproprietary Name

Atazanavir

Dosage Form

CAPSULE

Strength

300 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-713

Substance

ATAZANAVIR SULFATE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2018-06-25

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
10 Jan
Bulk Ingredient NDC: 65862-714

Nonproprietary Name

Raloxifene-Hydrochloride

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-714

Substance

RALOXIFENE HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-10

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
16 Jan
Bulk Ingredient NDC: 65862-719

Nonproprietary Name

Tadalafil

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-719

Substance

TADALAFIL

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-16

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
11 Jan
Bulk Ingredient NDC: 65862-720

Nonproprietary Name

Lacosamide

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-720

Substance

LACOSAMIDE

Product Type

BULK INGREDIENT

DEA Schedule

CV

Start Marketing Date

2024-01-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2017
17 Feb
Drug for Further Processing NDC: 65862-721

Nonproprietary Name

Rabeprazole Sodium

Dosage Form

TABLET, DELAYED RELEASE

Strength

20 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-721

Substance

RABEPRAZOLE SODIUM

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2017-02-17

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
09 Jan
Bulk Ingredient NDC: 65862-723

Nonproprietary Name

Esomeprazole Sodium

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-723

Substance

ESOMEPRAZOLE SODIUM

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-09

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
16 Jan
Bulk Ingredient NDC: 65862-727

Nonproprietary Name

Telmisartan

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-727

Substance

TELMISARTAN

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-16

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
09 Jan
Bulk Ingredient NDC: 65862-736

Nonproprietary Name

Palonosetron Hydrochloride

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-736

Substance

PALONOSETRON HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-09

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2017
24 Apr
Drug for Further Processing NDC: 65862-741

Nonproprietary Name

Olmesartan Medoxomil

Dosage Form

TABLET, FILM COATED

Strength

5 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-741

Substance

OLMESARTAN MEDOXOMIL

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2017-04-24

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2017
24 Apr
Drug for Further Processing NDC: 65862-742

Nonproprietary Name

Olmesartan Medoxomil

Dosage Form

TABLET, FILM COATED

Strength

20 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-742

Substance

OLMESARTAN MEDOXOMIL

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2017-04-24

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2017
24 Apr
Drug for Further Processing NDC: 65862-743

Nonproprietary Name

Olmesartan Medoxomil

Dosage Form

TABLET, FILM COATED

Strength

40 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-743

Substance

OLMESARTAN MEDOXOMIL

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2017-04-24

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
18 Jan
Bulk Ingredient NDC: 65862-754

Nonproprietary Name

Esomeprazole Magnesium Dihydrate

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-754

Substance

ESOMEPRAZOLE MAGNESIUM DIHYDRATE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-18

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
12 Jan
Bulk Ingredient NDC: 65862-756

Nonproprietary Name

Valganciclovir Hydrochloride

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-756

Substance

VALGANCICLOVIR HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-12

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
29 Mar
Drug for Further Processing NDC: 65862-758

Nonproprietary Name

PREGABALIN

Dosage Form

CAPSULE

Strength

25 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-758

Substance

PREGABALIN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

CV

Start Marketing Date

2023-03-29

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
29 Mar
Drug for Further Processing NDC: 65862-759

Nonproprietary Name

PREGABALIN

Dosage Form

CAPSULE

Strength

50 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-759

Substance

PREGABALIN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

CV

Start Marketing Date

2023-03-29

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
29 Mar
Drug for Further Processing NDC: 65862-760

Nonproprietary Name

PREGABALIN

Dosage Form

CAPSULE

Strength

75 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-760

Substance

PREGABALIN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

CV

Start Marketing Date

2023-03-29

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
29 Mar
Drug for Further Processing NDC: 65862-761

Nonproprietary Name

PREGABALIN

Dosage Form

CAPSULE

Strength

100 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-761

Substance

PREGABALIN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

CV

Start Marketing Date

2023-03-29

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
29 Mar
Drug for Further Processing NDC: 65862-762

Nonproprietary Name

PREGABALIN

Dosage Form

CAPSULE

Strength

150 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-762

Substance

PREGABALIN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

CV

Start Marketing Date

2023-03-29

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
29 Mar
Drug for Further Processing NDC: 65862-763

Nonproprietary Name

PREGABALIN

Dosage Form

CAPSULE

Strength

200 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-763

Substance

PREGABALIN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

CV

Start Marketing Date

2023-03-29

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
29 Mar
Drug for Further Processing NDC: 65862-764

Nonproprietary Name

PREGABALIN

Dosage Form

CAPSULE

Strength

225 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-764

Substance

PREGABALIN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

CV

Start Marketing Date

2023-03-29

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
29 Mar
Drug for Further Processing NDC: 65862-765

Nonproprietary Name

PREGABALIN

Dosage Form

CAPSULE

Strength

300 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-765

Substance

PREGABALIN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

CV

Start Marketing Date

2023-03-29

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2016
05 May
Drug for Further Processing NDC: 65862-768

Nonproprietary Name

Fenofibrate

Dosage Form

TABLET, COATED

Strength

48 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-768

Substance

FENOFIBRATE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2016-05-05

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2016
05 May
Drug for Further Processing NDC: 65862-769

Nonproprietary Name

Fenofibrate

Dosage Form

TABLET, COATED

Strength

145 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-769

Substance

FENOFIBRATE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2016-05-05

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2017
24 Apr
Drug for Further Processing NDC: 65862-779

Nonproprietary Name

Olmesartan Medoxomil and Hydrochlorothiazide

Dosage Form

TABLET, FILM COATED

Strength

12.5; 20 mg/1; mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-779

Substance

HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2017-04-24

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2017
24 Apr
Drug for Further Processing NDC: 65862-780

Nonproprietary Name

Olmesartan Medoxomil and Hydrochlorothiazide

Dosage Form

TABLET, FILM COATED

Strength

12.5; 40 mg/1; mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-780

Substance

HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2017-04-24

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2017
24 Apr
Drug for Further Processing NDC: 65862-781

Nonproprietary Name

Olmesartan Medoxomil and Hydrochlorothiazide

Dosage Form

TABLET, FILM COATED

Strength

25; 40 mg/1; mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-781

Substance

HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2017-04-24

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2016
21 Apr
Drug for Further Processing NDC: 65862-783

Nonproprietary Name

Esomeprazole Magnesium

Dosage Form

CAPSULE, DELAYED RELEASE

Strength

20 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-783

Substance

ESOMEPRAZOLE MAGNESIUM DIHYDRATE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2016-04-21

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2016
21 Apr
Drug for Further Processing NDC: 65862-784

Nonproprietary Name

Esomeprazole Magnesium

Dosage Form

CAPSULE, DELAYED RELEASE

Strength

40 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-784

Substance

ESOMEPRAZOLE MAGNESIUM DIHYDRATE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2016-04-21

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2016
18 Mar
Drug for Further Processing NDC: 65862-785

Nonproprietary Name

Naproxen Sodium

Dosage Form

TABLET, FILM COATED

Strength

220 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-785

Substance

NAPROXEN SODIUM

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2016-03-18

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
11 Jan
Bulk Ingredient NDC: 65862-790

Nonproprietary Name

Pregabalin

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-790

Substance

PREGABALIN

Product Type

BULK INGREDIENT

DEA Schedule

CV

Start Marketing Date

2024-01-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
06 Nov
Bulk Ingredient NDC: 65862-791

Nonproprietary Name

Cefixime

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-791

Substance

CEFIXIME

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-11-06

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
01 Nov
Bulk Ingredient NDC: 65862-792

Nonproprietary Name

Gatifloxacin Hemihydrate

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-792

Substance

GATIFLOXACIN HEMIHYDRATE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-11-01

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
02 Nov
Bulk Ingredient NDC: 65862-793

Nonproprietary Name

Celecoxib

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-793

Substance

CELECOXIB

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-11-02

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
03 Nov
Bulk Ingredient NDC: 65862-795

Nonproprietary Name

Armodafinil

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-795

Substance

ARMODAFINIL

Product Type

BULK INGREDIENT

DEA Schedule

CIV

Start Marketing Date

2023-11-03

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
14 Dec
Bulk Ingredient NDC: 65862-796

Nonproprietary Name

Bosentan Monohydrate

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-796

Substance

BOSENTAN

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-12-14

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
11 Dec
Bulk Ingredient NDC: 65862-797

Nonproprietary Name

Dutasteride

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-797

Substance

DUTASTERIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-12-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
06 Dec
Bulk Ingredient NDC: 65862-798

Nonproprietary Name

Entecavir

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-798

Substance

ENTECAVIR

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-12-06

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
08 Jan
Bulk Ingredient NDC: 65862-799

Nonproprietary Name

Cinacalcet Hydrochloride

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-799

Substance

CINACALCET HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-08

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
10 Jan
Bulk Ingredient NDC: 65862-800

Nonproprietary Name

Solifenacin Succinate

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-800

Substance

SOLIFENACIN SUCCINATE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-10

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
10 Jan
Bulk Ingredient NDC: 65862-801

Nonproprietary Name

Zolmitriptan

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-801

Substance

ZOLMITRIPTAN

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-10

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
05 Dec
Bulk Ingredient NDC: 65862-808

Nonproprietary Name

Methenamine Hippurate

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-808

Substance

METHENAMINE HIPPURATE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-12-05

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
10 Jan
Bulk Ingredient NDC: 65862-809

Nonproprietary Name

Prasugrel Hydrochloride

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-809

Substance

PRASUGREL HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-10

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
12 Jan
Bulk Ingredient NDC: 65862-810

Nonproprietary Name

Saxagliptin Monohydrate

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-810

Substance

SAXAGLIPTIN

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-12

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
05 Jan
Bulk Ingredient NDC: 65862-811

Nonproprietary Name

Pitavastatin Calcium

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-811

Substance

PITAVASTATIN CALCIUM

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-05

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
08 Jan
Bulk Ingredient NDC: 65862-843

Nonproprietary Name

Montelukast Sodium

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-843

Substance

MONTELUKAST SODIUM

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-08

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
10 Jan
Drug for Further Processing NDC: 65862-844

Nonproprietary Name

CLOZAPINE

Dosage Form

TABLET

Strength

25 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-844

Substance

CLOZAPINE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2024-01-10

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
10 Jan
Drug for Further Processing NDC: 65862-845

Nonproprietary Name

CLOZAPINE

Dosage Form

TABLET

Strength

50 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-845

Substance

CLOZAPINE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2024-01-10

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
10 Jan
Drug for Further Processing NDC: 65862-846

Nonproprietary Name

CLOZAPINE

Dosage Form

TABLET

Strength

100 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-846

Substance

CLOZAPINE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2024-01-10

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
10 Jan
Drug for Further Processing NDC: 65862-847

Nonproprietary Name

CLOZAPINE

Dosage Form

TABLET

Strength

200 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-847

Substance

CLOZAPINE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2024-01-10

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2019
26 Mar
Drug for Further Processing NDC: 65862-850

Nonproprietary Name

Tadalafil

Dosage Form

TABLET, FILM COATED

Strength

2.5 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-850

Substance

TADALAFIL

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2019-03-26

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2019
26 Mar
Drug for Further Processing NDC: 65862-851

Nonproprietary Name

Tadalafil

Dosage Form

TABLET, FILM COATED

Strength

5 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-851

Substance

TADALAFIL

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2019-03-26

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2019
26 Mar
Drug for Further Processing NDC: 65862-852

Nonproprietary Name

Tadalafil

Dosage Form

TABLET, FILM COATED

Strength

10 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-852

Substance

TADALAFIL

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2019-03-26

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2019
26 Mar
Drug for Further Processing NDC: 65862-853

Nonproprietary Name

Tadalafil

Dosage Form

TABLET, FILM COATED

Strength

20 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-853

Substance

TADALAFIL

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2019-03-26

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2015
22 Dec
Drug for Further Processing NDC: 65862-859

Nonproprietary Name

Famotidine

Dosage Form

TABLET, FILM COATED

Strength

20 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-859

Substance

FAMOTIDINE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2015-12-22

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2015
22 Dec
Drug for Further Processing NDC: 65862-860

Nonproprietary Name

Famotidine

Dosage Form

TABLET, FILM COATED

Strength

40 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-860

Substance

FAMOTIDINE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2015-12-22

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
08 Jan
Bulk Ingredient NDC: 65862-881

Nonproprietary Name

Darifenacin Hydrobromide

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-881

Substance

DARIFENACIN HYDROBROMIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-08

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
11 Jan
Bulk Ingredient NDC: 65862-911

Nonproprietary Name

Isosulfan Blue

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-911

Substance

ISOSULFAN BLUE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
12 Jan
Bulk Ingredient NDC: 65862-916

Nonproprietary Name

Voriconazole

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-916

Substance

VORICONAZOLE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-12

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
08 Jan
Bulk Ingredient NDC: 65862-917

Nonproprietary Name

Dalfampridine

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-917

Substance

DALFAMPRIDINE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-08

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
11 Jan
Bulk Ingredient NDC: 65862-920

Nonproprietary Name

Fondaparinux Sodium

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-920

Substance

FONDAPARINUX SODIUM

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
01 Nov
Bulk Ingredient NDC: 65862-923

Nonproprietary Name

Sevelamer Carbonate

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-923

Substance

SEVELAMER CARBONATE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-11-01

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
08 Nov
Bulk Ingredient NDC: 65862-924

Nonproprietary Name

Dextromethorphan Hydrobromide

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-924

Substance

DEXTROMETHORPHAN HYDROBROMIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-11-08

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
30 Mar
Drug for Further Processing NDC: 65862-929

Nonproprietary Name

nitrofurantoin (monohydrate/macrocrystals)

Dosage Form

CAPSULE

Strength

25; 75 mg/1; mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-929

Substance

NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2023-03-30

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2021
23 Aug
Drug for Further Processing NDC: 65862-936

Nonproprietary Name

PARICALCITOL

Dosage Form

CAPSULE, LIQUID FILLED

Strength

1 ug/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-936

Substance

PARICALCITOL

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2021-08-23

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2021
23 Aug
Drug for Further Processing NDC: 65862-937

Nonproprietary Name

PARICALCITOL

Dosage Form

CAPSULE, LIQUID FILLED

Strength

2 ug/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-937

Substance

PARICALCITOL

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2021-08-23

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2021
23 Aug
Drug for Further Processing NDC: 65862-938

Nonproprietary Name

PARICALCITOL

Dosage Form

CAPSULE, LIQUID FILLED

Strength

4 ug/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-938

Substance

PARICALCITOL

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2021-08-23

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
11 Jan
Bulk Ingredient NDC: 65862-950

Nonproprietary Name

Lurasidone HCl

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-950

Substance

LURASIDONE HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
11 Jan
Bulk Ingredient NDC: 65862-951

Nonproprietary Name

Dabigatran Etexilate Mesylate

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-951

Substance

DABIGATRAN ETEXILATE MESYLATE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
10 Mar
Drug for Further Processing NDC: 65862-953

Nonproprietary Name

LURASIDONE HYDROCHLORIDE

Dosage Form

TABLET

Strength

20 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-953

Substance

LURASIDONE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2023-03-10

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
10 Mar
Drug for Further Processing NDC: 65862-954

Nonproprietary Name

LURASIDONE HYDROCHLORIDE

Dosage Form

TABLET

Strength

40 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-954

Substance

LURASIDONE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2023-03-10

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
10 Mar
Drug for Further Processing NDC: 65862-955

Nonproprietary Name

LURASIDONE HYDROCHLORIDE

Dosage Form

TABLET

Strength

60 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-955

Substance

LURASIDONE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2023-03-10

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
10 Mar
Drug for Further Processing NDC: 65862-956

Nonproprietary Name

LURASIDONE HYDROCHLORIDE

Dosage Form

TABLET

Strength

80 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-956

Substance

LURASIDONE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2023-03-10

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
10 Mar
Drug for Further Processing NDC: 65862-957

Nonproprietary Name

LURASIDONE HYDROCHLORIDE

Dosage Form

TABLET

Strength

120 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-957

Substance

LURASIDONE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2023-03-10

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
11 Jan
Bulk Ingredient NDC: 65862-958

Nonproprietary Name

Naproxen

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-958

Substance

NAPROXEN

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
02 Nov
Bulk Ingredient NDC: 65862-962

Nonproprietary Name

Dolutegravir Sodium

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-962

Substance

DOLUTEGRAVIR SODIUM

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-11-02

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
18 Dec
Bulk Ingredient NDC: 65862-966

Nonproprietary Name

Fexofenadine Hydrochloride

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-966

Substance

FEXOFENADINE HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-12-18

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2016
15 Sep
Drug for Further Processing NDC: 65862-967

Nonproprietary Name

ESZOPICLONE

Dosage Form

TABLET, FILM COATED

Strength

1 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-967

Substance

ESZOPICLONE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

CIV

Start Marketing Date

2016-09-15

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2016
15 Sep
Drug for Further Processing NDC: 65862-968

Nonproprietary Name

ESZOPICLONE

Dosage Form

TABLET, FILM COATED

Strength

2 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-968

Substance

ESZOPICLONE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

CIV

Start Marketing Date

2016-09-15

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2016
15 Sep
Drug for Further Processing NDC: 65862-969

Nonproprietary Name

ESZOPICLONE

Dosage Form

TABLET, FILM COATED

Strength

3 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-969

Substance

ESZOPICLONE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

CIV

Start Marketing Date

2016-09-15

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
11 Jan
Bulk Ingredient NDC: 65862-970

Nonproprietary Name

Linagliptin

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-970

Substance

LINAGLIPTIN

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-11

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
12 Jan
Bulk Ingredient NDC: 65862-971

Nonproprietary Name

Rivaroxaban

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-971

Substance

RIVAROXABAN

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-12

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
08 Jan
Bulk Ingredient NDC: 65862-975

Nonproprietary Name

Divalproex Sodium

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-975

Substance

DIVALPROEX SODIUM

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-08

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2016
15 Dec
Drug for Further Processing NDC: 65862-976

Nonproprietary Name

Telmisartan and Hydrochlorothiazide

Dosage Form

TABLET

Strength

12.5; 40 mg/1; mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-976

Substance

HYDROCHLOROTHIAZIDE; TELMISARTAN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2016-12-15

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2016
15 Dec
Drug for Further Processing NDC: 65862-977

Nonproprietary Name

Telmisartan and Hydrochlorothiazide

Dosage Form

TABLET

Strength

12.5; 80 mg/1; mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-977

Substance

HYDROCHLOROTHIAZIDE; TELMISARTAN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2016-12-15

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2016
15 Dec
Drug for Further Processing NDC: 65862-978

Nonproprietary Name

Telmisartan and Hydrochlorothiazide

Dosage Form

TABLET

Strength

25; 80 mg/1; mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

65862-978

Substance

HYDROCHLOROTHIAZIDE; TELMISARTAN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2016-12-15

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
19 Jan
Bulk Ingredient NDC: 65862-979

Nonproprietary Name

Esomeprazole Magnesium Dihydrate Process II

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-979

Substance

ESOMEPRAZOLE MAGNESIUM DIHYDRATE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-19

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
10 Jan
Bulk Ingredient NDC: 65862-981

Nonproprietary Name

Ranolazine

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-981

Substance

RANOLAZINE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-01-10

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2023
14 Nov
Bulk Ingredient NDC: 65862-982

Nonproprietary Name

Rivastigmine

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

65862-982

Substance

RIVASTIGMINE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2023-11-14

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
07 Oct
Bulk Ingredient NDC: 84386-012

Nonproprietary Name

Rosuvastatin Calcium (Process II)

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

84386-012

Substance

ROSUVASTATIN CALCIUM

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-10-07

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
16 Oct
Bulk Ingredient NDC: 84386-014

Nonproprietary Name

Viloxazine Hydrochloride

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

84386-014

Substance

VILOXAZINE HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-10-16

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
24 Oct
Bulk Ingredient NDC: 84386-020

Nonproprietary Name

Brivaracetam

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

84386-020

Substance

BRIVARACETAM

Product Type

BULK INGREDIENT

DEA Schedule

CV

Start Marketing Date

2024-10-24

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2025
18 Mar
Bulk Ingredient NDC: 84386-021

Nonproprietary Name

Penicillin G Benzathine

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

84386-021

Substance

PENICILLIN G BENZATHINE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2025-03-18

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2025
22 Jan
Bulk Ingredient NDC: 84386-027

Nonproprietary Name

Olmesartan Medoxomil (Process-II)

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

84386-027

Substance

OLMESARTAN MEDOXOMIL

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2025-01-22

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2025
22 Jan
Bulk Ingredient NDC: 84386-028

Nonproprietary Name

Perampanel Hemisesquihydrate

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

84386-028

Substance

PERAMPANEL HYDRATE (4:3)

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2025-01-22

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2025
22 Jan
Bulk Ingredient NDC: 84386-029

Nonproprietary Name

Prucalopride Succinate

Dosage Form

POWDER

Strength

1 kg/kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

84386-029

Substance

PRUCALOPRIDE SUCCINATE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2025-01-22

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2024
16 Dec
Bulk Ingredient NDC: 84386-030

Nonproprietary Name

Rifaximin

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

84386-030

Substance

RIFAXIMIN

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2024-12-16

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2025
21 Nov
Drug for Further Processing NDC: 84386-035

Nonproprietary Name

BACLOFEN

Dosage Form

TABLET

Strength

5 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

84386-035

Substance

BACLOFEN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2025-11-21

End Marketing Date

-

Listing Record Certified Through

2027-12-31

2025
23 Jan
Bulk Ingredient NDC: 84386-049

Nonproprietary Name

Sitagliptin Phosphate Anhydrous (Process-II)

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

84386-049

Substance

SITAGLIPTIN PHOSPHATE ANHYDROUS

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2025-01-23

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2025
22 Jan
Bulk Ingredient NDC: 84386-050

Nonproprietary Name

Tamoxifen Citrate

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

84386-050

Substance

TAMOXIFEN CITRATE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2025-01-22

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2025
22 Jan
Bulk Ingredient NDC: 84386-051

Nonproprietary Name

Belumosudil Mesylate

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

84386-051

Substance

BELUMOSUDIL MESYLATE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2025-01-22

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2025
21 Feb
Bulk Ingredient NDC: 84386-058

Nonproprietary Name

Clorazepate Dipotassium

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

84386-058

Substance

CLORAZEPATE DIPOTASSIUM

Product Type

BULK INGREDIENT

DEA Schedule

CIV

Start Marketing Date

2025-02-21

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2025
21 Feb
Bulk Ingredient NDC: 84386-059

Nonproprietary Name

Cabotegravir

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

84386-059

Substance

CABOTEGRAVIR

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2025-02-21

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2025
02 Aug
Drug for Further Processing NDC: 84386-060

Nonproprietary Name

Auropap 90F (Acetaminophen Directly Compressible Granules)

Dosage Form

GRANULE

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

84386-060

Substance

ACETAMINOPHEN

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2025-08-02

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2025
01 Mar
Bulk Ingredient NDC: 84386-061

Nonproprietary Name

Calcium Carbonate

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

84386-061

Substance

CALCIUM CARBONATE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2025-03-01

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2025
01 Mar
Bulk Ingredient NDC: 84386-062

Nonproprietary Name

Mirtazapine (Process-II)

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

84386-062

Substance

MIRTAZAPINE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2025-03-01

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2025
25 Mar
Bulk Ingredient NDC: 84386-079

Nonproprietary Name

Enoxaparin Sodium

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

84386-079

Substance

ENOXAPARIN SODIUM

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2025-03-25

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2025
19 May
Bulk Ingredient NDC: 84386-095

Nonproprietary Name

Divalproex Sodium (Process-II)

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

84386-095

Substance

DIVALPROEX SODIUM

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2025-05-19

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2025
20 Nov
Drug for Further Processing NDC: 84386-097

Nonproprietary Name

Sertraline Hydrochloride

Dosage Form

TABLET, FILM COATED

Strength

25 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

84386-097

Substance

SERTRALINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2025-11-20

End Marketing Date

-

Listing Record Certified Through

2027-12-31

2025
20 Nov
Drug for Further Processing NDC: 84386-098

Nonproprietary Name

Sertraline Hydrochloride

Dosage Form

TABLET, FILM COATED

Strength

50 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

84386-098

Substance

SERTRALINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2025-11-20

End Marketing Date

-

Listing Record Certified Through

2027-12-31

2025
20 Nov
Drug for Further Processing NDC: 84386-099

Nonproprietary Name

Sertraline Hydrochloride

Dosage Form

TABLET, FILM COATED

Strength

100 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

84386-099

Substance

SERTRALINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2025-11-20

End Marketing Date

-

Listing Record Certified Through

2027-12-31

2026
13 Jan
Drug for Further Processing NDC: 84386-100

Nonproprietary Name

Benazepril Hydrochloride

Dosage Form

TABLET, FILM COATED

Strength

10 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

84386-100

Substance

BENAZEPRIL HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2026-01-13

End Marketing Date

-

Listing Record Certified Through

2027-12-31

2026
13 Jan
Drug for Further Processing NDC: 84386-101

Nonproprietary Name

Benazepril Hydrochloride

Dosage Form

TABLET, FILM COATED

Strength

20 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

84386-101

Substance

BENAZEPRIL HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2026-01-13

End Marketing Date

-

Listing Record Certified Through

2027-12-31

2026
13 Jan
Drug for Further Processing NDC: 84386-102

Nonproprietary Name

Benazepril Hydrochloride

Dosage Form

TABLET, FILM COATED

Strength

40 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

84386-102

Substance

BENAZEPRIL HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2026-01-13

End Marketing Date

-

Listing Record Certified Through

2027-12-31

2026
15 Jan
Drug for Further Processing NDC: 84386-104

Nonproprietary Name

Fluoxetine

Dosage Form

TABLET, FILM COATED

Strength

10 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

84386-104

Substance

FLUOXETINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2026-01-15

End Marketing Date

-

Listing Record Certified Through

2027-12-31

2026
15 Jan
Drug for Further Processing NDC: 84386-105

Nonproprietary Name

Fluoxetine

Dosage Form

TABLET, FILM COATED

Strength

20 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

84386-105

Substance

FLUOXETINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2026-01-15

End Marketing Date

-

Listing Record Certified Through

2027-12-31

2026
15 Jan
Drug for Further Processing NDC: 84386-106

Nonproprietary Name

Fluoxetine

Dosage Form

TABLET, FILM COATED

Strength

60 mg/1

Labeler

Aurobindo Pharma Limited

Marketing Category

DRUG FOR FURTHER PROCESSING

84386-106

Substance

FLUOXETINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2026-01-15

End Marketing Date

-

Listing Record Certified Through

2027-12-31

2025
06 Oct
Bulk Ingredient NDC: 84386-136

Nonproprietary Name

Vonoprazan Fumarate

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

84386-136

Substance

VONOPRAZAN FUMARATE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2025-10-06

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2025
16 Oct
Bulk Ingredient NDC: 84386-137

Nonproprietary Name

Methocarbamol

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

84386-137

Substance

METHOCARBAMOL

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2025-10-16

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2025
10 Oct
Bulk Ingredient NDC: 84386-138

Nonproprietary Name

Mavacamten

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

84386-138

Substance

MAVACAMTEN

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2025-10-10

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2025
21 Nov
Bulk Ingredient NDC: 84386-139

Nonproprietary Name

Pitavastatin Calcium (Process-II)

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

84386-139

Substance

PITAVASTATIN CALCIUM

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2025-11-21

End Marketing Date

-

Listing Record Certified Through

2026-12-31

2026
20 Jan
Bulk Ingredient NDC: 84386-157

Nonproprietary Name

Montelukast Sodium

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

84386-157

Substance

MONTELUKAST SODIUM

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2026-01-20

End Marketing Date

-

Listing Record Certified Through

2027-12-31

2026
13 Jan
Bulk Ingredient NDC: 84386-158

Nonproprietary Name

Bupropion Hydrochloride

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

84386-158

Substance

BUPROPION HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2026-01-13

End Marketing Date

-

Listing Record Certified Through

2027-12-31

2026
09 Feb
Bulk Ingredient NDC: 84386-162

Nonproprietary Name

Suvorexant

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

84386-162

Substance

SUVOREXANT

Product Type

BULK INGREDIENT

DEA Schedule

CIV

Start Marketing Date

2026-02-09

End Marketing Date

-

Listing Record Certified Through

2027-12-31

2026
05 Feb
Bulk Ingredient NDC: 84386-163

Nonproprietary Name

Cabotegravir Sodium

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

84386-163

Substance

CABOTEGRAVIR SODIUM

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2026-02-05

End Marketing Date

-

Listing Record Certified Through

2027-12-31

2026
26 Feb
Bulk Ingredient NDC: 84386-171

Nonproprietary Name

Emtricitabine (Process-IV)

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

84386-171

Substance

EMTRICITABINE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2026-02-26

End Marketing Date

-

Listing Record Certified Through

2027-12-31

2026
18 Mar
Bulk Ingredient NDC: 84386-185

Nonproprietary Name

Valganciclovir Hydrochloride (Process-II)

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

84386-185

Substance

VALGANCICLOVIR HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2026-03-18

End Marketing Date

-

Listing Record Certified Through

2027-12-31

2026
25 Mar
Bulk Ingredient NDC: 84386-186

Nonproprietary Name

Desvenlafaxine Succinate (Process-II)

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

84386-186

Substance

DESVENLAFAXINE SUCCINATE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2026-03-25

End Marketing Date

-

Listing Record Certified Through

2027-12-31

2026
31 Mar
Bulk Ingredient NDC: 84386-187

Nonproprietary Name

Magnesium Hydroxide

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

84386-187

Substance

MAGNESIUM HYDROXIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2026-03-31

End Marketing Date

-

Listing Record Certified Through

2027-12-31

2026
17 Jun
Bulk Ingredient NDC: 84386-202

Nonproprietary Name

Avibactam Sodium (Non-Sterile)

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

84386-202

Substance

AVIBACTAM SODIUM

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2026-06-17

End Marketing Date

-

Listing Record Certified Through

2027-12-31

2026
16 Jun
Bulk Ingredient NDC: 84386-203

Nonproprietary Name

Benzgalantamine Gluconate

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

84386-203

Substance

BENZGALANTAMINE GLUCONATE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2026-06-16

End Marketing Date

-

Listing Record Certified Through

2027-12-31

2026
11 Jun
Bulk Ingredient NDC: 84386-204

Nonproprietary Name

Bupropion Hydrobromide

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

84386-204

Substance

BUPROPION HYDROBROMIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2026-06-11

End Marketing Date

-

Listing Record Certified Through

2027-12-31

2026
15 Jun
Bulk Ingredient NDC: 84386-205

Nonproprietary Name

Lenacapavir Sodium

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

84386-205

Substance

LENACAPAVIR SODIUM

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2026-06-15

End Marketing Date

-

Listing Record Certified Through

2027-12-31

2026
11 Jun
Bulk Ingredient NDC: 84386-206

Nonproprietary Name

Pivmecillinam Hydrochloride

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

84386-206

Substance

PIVMECILLINAM HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2026-06-11

End Marketing Date

-

Listing Record Certified Through

2027-12-31

2026
15 Jun
Bulk Ingredient NDC: 84386-207

Nonproprietary Name

Zavegepant Hydrochloride

Dosage Form

POWDER

Strength

50 kg/50kg

Labeler

Aurobindo Pharma Limited

Marketing Category

BULK INGREDIENT

84386-207

Substance

ZAVEGEPANT HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2026-06-15

End Marketing Date

-

Listing Record Certified Through

2027-12-31

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NDC Type Breakdown
869 total
  • Drug for Further Processing
  • Bulk Ingredient
Official Source

NDC data is based on publicly available National Drug Code information from the U.S. Food and Drug Administration (FDA).

Visit FDA NDC Directory
NDC Record Details Preview

Explore important National Drug Code information available in the records above.

NDC

59651-001

Nonproprietary Name

Omeprazole

Labeler

Aurobindo Pharma Limited

Dosage Form

CAPSULE, DELAYED RELEASE

FDA NDC Data

National Drug Code information

Regular Updates

Data maintained from official sources

Structured Database

Searchable pharmaceutical data

Reliable Data

Organized NDC records

NDC data is based on publicly available U.S. Food and Drug Administration (FDA) National Drug Code information.

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