Gabapentin

Basic Information

Product Name

Gabapentin

FDA Product Code

68788-8489

Regulatory Information

NDC Product Code

68788-8489

Application Number

ANDA204989

Marketing Category

C73584

Effective Date

July 21, 2023

Territorial Authority

USA

FDA Title

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

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

TALC

Code: 7SEV7J4R1U

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

GELATIN, UNSPECIFIED

Code: 2G86QN327L

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

GABAPENTIN

Quantity: 100 mg in 1 1

Code: 6CW7F3G59X

Class Code: ACTIB

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

Active Moieties

Code: 6CW7F3G59X

Gabapentin

Basic Information

Regulatory Information

Company Information

Active Ingredients

TALC

STARCH, CORN

GELATIN, UNSPECIFIED

TITANIUM DIOXIDE

SODIUM LAURYL SULFATE

Active Moieties

GABAPENTIN