Gabapentin

Product NDC

45861-011

11-digit product format

458610011

Labeler code

45861

Product ID

45861-011_b7de5c70-4b14-4f5c-b1ca-b8e73be4de01

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Gabapentin

Dosage form

CAPSULE

Route

ORAL

Labeler

Pharmaceutica North America, Inc.

Application

ANDA090705

Marketing category

ANDA

Marketing start

2012-08-09

Marketing end

0000-00-00

Substance

GABAPENTIN

Active strength

300 mg/1

Pharmacologic classes

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

NDC exclude flag

E

Listing certified through

2018-12-31

Current FDA listing

Historical FDA.report record