GABAPENTIN

Product NDC

45861-111

11-digit product format

458610111

Labeler code

45861

Product ID

45861-111_9e916b9d-b233-44e1-ac33-5acf741611fe

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

GABAPENTIN

Dosage form

CAPSULE

Route

ORAL

Labeler

Pharmaceutica North America, Inc.

Application

ANDA077242

Marketing category

ANDA

Marketing start

2014-02-12

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