Gabapentin

Basic Information

Product Name

Gabapentin

FDA Product Code

68071-4978

Regulatory Information

NDC Product Code

68071-4978

Application Number

ANDA206943

Marketing Category

C73584

Effective Date

June 16, 2023

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 use Initial U.S. Approval:1993

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

FERROSOFERRIC OXIDE

Code: XM0M87F357

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

GELATIN

Code: 2G86QN327L

Class Code: IACT

BUTYL ALCOHOL

Code: 8PJ61P6TS3

Class Code: IACT

POTASSIUM HYDROXIDE

Code: WZH3C48M4T

Class Code: IACT

SHELLAC

Code: 46N107B71O

Class Code: IACT

ALCOHOL

Code: 3K9958V90M

Class Code: IACT

ISOPROPYL ALCOHOL

Code: ND2M416302

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

AMMONIA

Code: 5138Q19F1X

Class Code: IACT

GABAPENTIN

Quantity: 100 mg in 1 1

Code: 6CW7F3G59X

Class Code: ACTIB

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

Active Moieties

Code: 6CW7F3G59X

Gabapentin

Basic Information

Regulatory Information

Company Information

Active Ingredients

FERROSOFERRIC OXIDE

STARCH, CORN

TALC

GELATIN

BUTYL ALCOHOL

POTASSIUM HYDROXIDE

SHELLAC

ALCOHOL

ISOPROPYL ALCOHOL

PROPYLENE GLYCOL

AMMONIA

TITANIUM DIOXIDE

Active Moieties

GABAPENTIN