FDA Product

GABAPENTIN

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

Basic Information

Product Name

GABAPENTIN

FDA Product Code

61919-839

Regulatory Information

NDC Product Code

61919-839

Application Number

ANDA075350

Marketing Category

C73584

Effective Date

April 4, 2016

Territorial Authority

USA

FDA Title

GABAPENTIN 300mg 30CAPS

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

1

Company Information

ManufacturerDIRECT RX

DUNS Number

079254320

Active Ingredients

Quantity: 300 mg in 1 1

Code: 6CW7F3G59X

Class Code: ACTIB

Inactive Ingredients

D&C YELLOW NO. 10

Code: 35SW5USQ3G

Class Code: IACT

FERROSOFERRIC OXIDE

Code: XM0M87F357

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

SHELLAC

Code: 46N107B71O

Class Code: IACT

FD&C BLUE NO. 2

Code: L06K8R7DQK

Class Code: IACT

FD&C BLUE NO. 1

Code: H3R47K3TBD

Class Code: IACT

GELATIN

Code: 2G86QN327L

Class Code: IACT

MANNITOL

Code: 3OWL53L36A

Class Code: IACT

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

FD&C RED NO. 40

Code: WZB9127XOA

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

FERRIC OXIDE RED

Code: 1K09F3G675

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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