Gabapentin

Product NDC

67544-354

11-digit product format

675440354

Labeler code

67544

Product ID

67544-354_03cba200-f94b-4357-bee2-b32b12f19891

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Gabapentin

Dosage form

CAPSULE

Route

ORAL

Labeler

Aphena Pharma Solutions - Tennessee, LLC

Application

ANDA075350

Marketing category

ANDA

Marketing start

2004-10-04

Marketing end

0000-00-00

Substance

GABAPENTIN

Active strength

400 mg/1

Pharmacologic classes

Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]

NDC exclude flag

No

Listing certified through

2019-12-31

Current FDA listing

Historical FDA.report record