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FDA Product

GABAPENTIN

Product approved by U.S. Food and Drug Administration (US)

Basic Information

GABAPENTIN

72189-113

Regulatory Information

72189-113

ANDA090007

C73584

June 28, 2023

USA

GABAPENTIN

HUMAN PRESCRIPTION DRUG LABEL

13

Company Information

DIRECT RX

079254320

Active Ingredients

GABAPENTIN

Quantity: 400 mg in 1 1

Code: 6CW7F3G59X

Class Code: ACTIB

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

GELATIN

Code: 2G86QN327L

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

FD&C BLUE NO. 2

Code: L06K8R7DQK

Class Code: IACT

SHELLAC

Code: 46N107B71O

Class Code: IACT

Active Moieties

GABAPENTIN

Code: 6CW7F3G59X

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