Gabapentin

Basic Information

Product Name

Gabapentin

FDA Product Code

71335-1375

Regulatory Information

NDC Product Code

71335-1375

Application Number

ANDA206943

Marketing Category

C73584

Effective Date

February 11, 2022

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES.GABAPENTIN capsules, for oral useInitial U.S. Approval: 1993

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

101

Active Ingredients

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

GABAPENTIN

Quantity: 100 mg in 1 1

Code: 6CW7F3G59X

Class Code: ACTIB

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

GELATIN, UNSPECIFIED

Code: 2G86QN327L

Class Code: IACT

FERROSOFERRIC OXIDE

Code: XM0M87F357

Class Code: IACT

ALCOHOL

Code: 3K9958V90M

Class Code: IACT

BUTYL ALCOHOL

Code: 8PJ61P6TS3

Class Code: IACT

ISOPROPYL ALCOHOL

Code: ND2M416302

Class Code: IACT

POTASSIUM HYDROXIDE

Code: WZH3C48M4T

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

AMMONIA

Code: 5138Q19F1X

Class Code: IACT

SHELLAC

Code: 46N107B71O

Class Code: IACT

Active Moieties

Code: 6CW7F3G59X

Gabapentin

Basic Information

Regulatory Information

Company Information

Active Ingredients

TITANIUM DIOXIDE

STARCH, CORN

TALC

GELATIN, UNSPECIFIED

FERROSOFERRIC OXIDE

ALCOHOL

BUTYL ALCOHOL

ISOPROPYL ALCOHOL

POTASSIUM HYDROXIDE

PROPYLENE GLYCOL

AMMONIA

SHELLAC

Active Moieties

GABAPENTIN