Cyclobenzaprine Hydrochloride - NDC Database

NDC Database
22 labelers
Cyclobenzaprine Hydrochloride

Cyclobenzaprine Hydrochloride

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

DRUG FOR FURTHER PROCESSINGBULK INGREDIENT
Last Marketing Date
2022-05-20
Data Source
FDA
First Marketing Date
1982-01-01
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NDC Records Timeline (26 records)
Clear
2009
12 May
Adare Pharmaceuticals, Inc.
DRUG FOR FURTHER PROCESSING

NDC

59917-090

Labeler

Adare Pharmaceuticals, Inc.

Nonproprietary Name

Cyclobenzaprine Hydrochloride

Marketing Category

DRUG FOR FURTHER PROCESSING

Dosage Form

CAPSULE, EXTENDED RELEASE

Strength

15 mg/1

Start Marketing: 2009-05-12

Substance

CYCLOBENZAPRINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2009-05-12

End Marketing Date

-

Listing / Certification

2026-12-31

2009
12 May
Adare Pharmaceuticals, Inc.
DRUG FOR FURTHER PROCESSING

NDC

59917-091

Labeler

Adare Pharmaceuticals, Inc.

Nonproprietary Name

Cyclobenzaprine Hydrochloride

Marketing Category

DRUG FOR FURTHER PROCESSING

Dosage Form

CAPSULE, EXTENDED RELEASE

Strength

30 mg/1

Start Marketing: 2009-05-12

Substance

CYCLOBENZAPRINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2009-05-12

End Marketing Date

-

Listing / Certification

2026-12-31

2019
11 Sep
Asclemed USA, Inc.
BULK INGREDIENT

NDC

76420-168

Labeler

Asclemed USA, Inc.

Nonproprietary Name

Cyclobenzaprine Hydrochloride

Marketing Category

BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING

Dosage Form

POWDER

Strength

1 g/g

Start Marketing: 2019-09-11

Substance

CYCLOBENZAPRINE HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2019-09-11

End Marketing Date

-

Listing / Certification

2026-12-31

2022
20 May
AX Pharmaceutical Corp
BULK INGREDIENT

NDC

73377-168

Labeler

AX Pharmaceutical Corp

Nonproprietary Name

Cyclobenzaprine Hudrochloride

Marketing Category

BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING

Dosage Form

POWDER

Strength

1 g/g

Start Marketing: 2022-05-20

Substance

CYCLOBENZAPRINE HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2022-05-20

End Marketing Date

-

Listing / Certification

2026-12-31

2018
07 Nov
Derivados Quimicos
BULK INGREDIENT

NDC

59349-0014

Labeler

Derivados Quimicos

Nonproprietary Name

Cyclobenzaprine Hydrochloride

Marketing Category

BULK INGREDIENT

Dosage Form

POWDER

Strength

1 kg/kg

Start Marketing: 2018-11-07

Substance

CYCLOBENZAPRINE HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2018-11-07

End Marketing Date

-

Listing / Certification

2026-12-31

2016
01 Dec
Dipharma Francis Srl
BULK INGREDIENT

NDC

46438-0050

Labeler

Dipharma Francis Srl

Nonproprietary Name

Cyclobenzaprine Hydrochloride

Marketing Category

BULK INGREDIENT

Dosage Form

POWDER

Strength

1 kg/kg

Start Marketing: 2016-12-01

Substance

CYCLOBENZAPRINE HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2016-12-01

End Marketing Date

-

Listing / Certification

2026-12-31

2004
12 Jan
Dipharma Francis Srl
BULK INGREDIENT

NDC

46438-0631

Labeler

Dipharma Francis Srl

Nonproprietary Name

Cyclobenzaprine Hydrochloride

Marketing Category

BULK INGREDIENT

Dosage Form

POWDER

Strength

1 kg/kg

Start Marketing: 2004-01-12

Substance

CYCLOBENZAPRINE HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2004-01-12

End Marketing Date

-

Listing / Certification

2026-12-31

2004
01 Sep
Fagron Inc
BULK INGREDIENT

NDC

51552-0483

Labeler

Fagron Inc

Nonproprietary Name

Cyclobenzaprine Hcl

Marketing Category

BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING

Dosage Form

POWDER

Strength

1 g/g

Start Marketing: 2004-09-01

Substance

CYCLOBENZAPRINE HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2004-09-01

End Marketing Date

2027-09-30

Listing / Certification

-

2021
15 Apr
FLOWCHEM PHARMA PRIVATE LIMITED
BULK INGREDIENT

NDC

82060-001

Labeler

FLOWCHEM PHARMA PRIVATE LIMITED

Nonproprietary Name

CYCLOBENZAPRINE HYDROCHLORIDE

Marketing Category

BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING

Dosage Form

POWDER

Strength

1 kg/kg

Start Marketing: 2021-04-15

Substance

CYCLOBENZAPRINE HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2021-04-15

End Marketing Date

-

Listing / Certification

2026-12-31

2021
01 May
Galenova Inc
BULK INGREDIENT

NDC

79572-011

Labeler

Galenova Inc

Nonproprietary Name

CYCLOBENZAPRINE HYDROCHLORIDE

Marketing Category

BULK INGREDIENT

Dosage Form

POWDER

Strength

1 kg/kg

Start Marketing: 2021-05-01

Substance

CYCLOBENZAPRINE HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2021-05-01

End Marketing Date

-

Listing / Certification

2026-12-31

2012
01 Jan
Harman Finochem Limited
BULK INGREDIENT

NDC

66064-1022

Labeler

Harman Finochem Limited

Nonproprietary Name

Cyclobenzaprine Hydrochloride

Marketing Category

BULK INGREDIENT

Dosage Form

POWDER

Strength

25 kg/25kg

Start Marketing: 2012-01-01

Substance

CYCLOBENZAPRINE HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2012-01-01

End Marketing Date

-

Listing / Certification

2026-12-31

1982
01 Jan
Hetero Drugs Limited
BULK INGREDIENT

NDC

65977-0030

Labeler

Hetero Drugs Limited

Nonproprietary Name

Cyclobenzaprine Hydrochloride

Marketing Category

BULK INGREDIENT

Dosage Form

POWDER

Strength

1 kg/kg

Start Marketing: 1982-01-01

Substance

CYCLOBENZAPRINE HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

1982-01-01

End Marketing Date

-

Listing / Certification

2026-12-31

2011
01 Apr
Jubilant Biosys limited
BULK INGREDIENT

NDC

65372-1156

Labeler

Jubilant Biosys limited

Nonproprietary Name

CYCLOBENZAPRINE HYDROCHLORIDE

Marketing Category

BULK INGREDIENT

Dosage Form

POWDER

Strength

1 kg/kg

Start Marketing: 2011-04-01

Substance

CYCLOBENZAPRINE HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2011-04-01

End Marketing Date

-

Listing / Certification

2026-12-31

2011
27 Sep
LETCO MEDICAL, LLC
BULK INGREDIENT

NDC

62991-1040

Labeler

LETCO MEDICAL, LLC

Nonproprietary Name

Cyclobenzaprine Hydrochloride

Marketing Category

BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING

Dosage Form

POWDER

Strength

1 g/g

Start Marketing: 2011-09-27

Substance

CYCLOBENZAPRINE HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2011-09-27

End Marketing Date

-

Listing / Certification

2027-12-31

2010
15 Mar
Medichem S.A.
BULK INGREDIENT

NDC

53296-0003

Labeler

Medichem S.A.

Nonproprietary Name

Cyclobenzaprine Hydrochloride

Marketing Category

BULK INGREDIENT

Dosage Form

POWDER

Strength

75 kg/75kg

Start Marketing: 2010-03-15

Substance

CYCLOBENZAPRINE HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2010-03-15

End Marketing Date

-

Listing / Certification

2026-12-31

2012
29 Mar
Medisca Inc.
BULK INGREDIENT

NDC

38779-0395

Labeler

Medisca Inc.

Nonproprietary Name

Cyclobenzaprine Hydrochloride

Marketing Category

BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING

Dosage Form

POWDER

Strength

1 g/g

Start Marketing: 2012-03-29

Substance

CYCLOBENZAPRINE HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2012-03-29

End Marketing Date

-

Listing / Certification

2026-12-31

2021
01 Jun
Professional Compounding Centers of America
BULK INGREDIENT

NDC

51927-0118

Labeler

Professional Compounding Centers of America

Nonproprietary Name

CYCLOBENZAPRINE

Marketing Category

BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING

Dosage Form

POWDER

Strength

1 kg/kg

Start Marketing: 2021-06-01

Substance

CYCLOBENZAPRINE HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2021-06-01

End Marketing Date

-

Listing / Certification

2027-12-31

2020
18 May
R.L.Fine Chem Private Limited
BULK INGREDIENT

NDC

71554-116

Labeler

R.L.Fine Chem Private Limited

Nonproprietary Name

CYCLOBENZAPRINE HYDROCHLORIDE

Marketing Category

BULK INGREDIENT

Dosage Form

POWDER

Strength

1 kg/kg

Start Marketing: 2020-05-18

Substance

CYCLOBENZAPRINE HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2020-05-18

End Marketing Date

-

Listing / Certification

2026-12-31

2006
01 Jan
Vasudha Pharma Chem Limited
BULK INGREDIENT

NDC

66577-013

Labeler

Vasudha Pharma Chem Limited

Nonproprietary Name

Cyclobenzaprine Hydrochloride

Marketing Category

BULK INGREDIENT

Dosage Form

POWDER

Strength

1 kg/kg

Start Marketing: 2006-01-01

Substance

CYCLOBENZAPRINE HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2006-01-01

End Marketing Date

-

Listing / Certification

2027-12-31

2017
01 Sep
Village Pharma LLC
BULK INGREDIENT

NDC

71574-112

Labeler

Village Pharma LLC

Nonproprietary Name

CYCLOBENZAPRINE HYDROCHLORIDE

Marketing Category

BULK INGREDIENT

Dosage Form

POWDER

Strength

1 kg/kg

Start Marketing: 2017-09-01

Substance

CYCLOBENZAPRINE HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2017-09-01

End Marketing Date

-

Listing / Certification

2026-12-31

2022
31 Mar
Willow Birch Pharma, LLC
BULK INGREDIENT

NDC

10695-117

Labeler

Willow Birch Pharma, LLC

Nonproprietary Name

Cyclobenzaprine HCL

Marketing Category

BULK INGREDIENT

Dosage Form

POWDER

Strength

1 kg/kg

Start Marketing: 2022-03-31

Substance

CYCLOBENZAPRINE HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2022-03-31

End Marketing Date

-

Listing / Certification

2026-12-31

2020
30 Oct
Xenex Laboratories Inc
BULK INGREDIENT

NDC

68981-008

Labeler

Xenex Laboratories Inc

Nonproprietary Name

CYCLOBENZAPRINE HYDROCHLORIDE

Marketing Category

BULK INGREDIENT

Dosage Form

POWDER

Strength

1 g/g

Start Marketing: 2020-10-30

Substance

CYCLOBENZAPRINE HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2020-10-30

End Marketing Date

-

Listing / Certification

2026-12-31

2020
30 Oct
Xenex Laboratories Inc
BULK INGREDIENT

NDC

68981-009

Labeler

Xenex Laboratories Inc

Nonproprietary Name

GABAPENTIN

Marketing Category

BULK INGREDIENT

Dosage Form

POWDER

Strength

1 g/g

Start Marketing: 2020-10-30

Substance

CYCLOBENZAPRINE HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2020-10-30

End Marketing Date

-

Listing / Certification

2026-12-31

2008
26 Sep
DRUG FOR FURTHER PROCESSING

NDC

65862-190

Labeler

Aurobindo Pharma Limited

Nonproprietary Name

Cyclobenzaprine Hydrochloride

Marketing Category

DRUG FOR FURTHER PROCESSING

Dosage Form

TABLET, FILM COATED

Strength

5 mg/1

Start Marketing: 2008-09-26

Substance

CYCLOBENZAPRINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2008-09-26

End Marketing Date

-

Listing / Certification

2026-12-31

2008
26 Sep
DRUG FOR FURTHER PROCESSING

NDC

65862-191

Labeler

Aurobindo Pharma Limited

Nonproprietary Name

Cyclobenzaprine Hydrochloride

Marketing Category

DRUG FOR FURTHER PROCESSING

Dosage Form

TABLET, FILM COATED

Strength

10 mg/1

Start Marketing: 2008-09-26

Substance

CYCLOBENZAPRINE HYDROCHLORIDE

Product Type

DRUG FOR FURTHER PROCESSING

DEA Schedule

Start Marketing Date

2008-09-26

End Marketing Date

-

Listing / Certification

2026-12-31

2019
29 Nov
BULK INGREDIENT

NDC

60592-041

Labeler

Kalchem International inc

Nonproprietary Name

CYCLOBENZAPRINE HCL

Marketing Category

BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING

Dosage Form

POWDER

Strength

1 g/g

Start Marketing: 2019-11-29

Substance

CYCLOBENZAPRINE HYDROCHLORIDE

Product Type

BULK INGREDIENT

DEA Schedule

Start Marketing Date

2019-11-29

End Marketing Date

-

Listing / Certification

2026-12-31

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Product Type Breakdown
26 total
  • BULK INGREDIENT
  • DRUG FOR FURTHER PROCESSING
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
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Substance

CYCLOBENZAPRINE HYDROCHLORIDE

Identifiers

NDC: 59917-090
DEA Schedule:

Official FDA Data

Based on publicly available FDA NDC information

National Drug Code

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Product Information

Drug, labeler and marketing data

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