MedPath
FDA Product

Gabapentin

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

Basic Information

Gabapentin

68151-1030

Regulatory Information

68151-1030

ANDA075350

C73584

March 26, 2015

USA

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, USP for oral use Initial U.S. Approval: 1993

HUMAN PRESCRIPTION DRUG LABEL

2

Company Information

079239644

Active Ingredients

GABAPENTIN

Quantity: 400 mg in 1 1

Code: 6CW7F3G59X

Class Code: ACTIB

GELATIN

Code: 2G86QN327L

Class Code: IACT

FD&C RED NO. 40

Code: WZB9127XOA

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

FERROSOFERRIC OXIDE

Code: XM0M87F357

Class Code: IACT

MANNITOL

Code: 3OWL53L36A

Class Code: IACT

SHELLAC

Code: 46N107B71O

Class Code: IACT

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

D&C YELLOW NO. 10

Code: 35SW5USQ3G

Class Code: IACT

FD&C BLUE NO. 2

Code: L06K8R7DQK

Class Code: IACT

FD&C BLUE NO. 1

Code: H3R47K3TBD

Class Code: IACT

FERRIC OXIDE RED

Code: 1K09F3G675

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

Active Moieties

GABAPENTIN

Code: 6CW7F3G59X

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