Baclofen

Product NDC

0904-5222

11-digit product format

009045222

Labeler code

0904

Product ID

0904-5222_db95493e-fc0b-473a-aeef-fef88e8cbcc5

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Baclofen

Dosage form

TABLET

Route

ORAL

Labeler

Major Pharmaceuticals

Application

ANDA072235

Marketing category

ANDA

Marketing start

1998-07-21

Marketing end

0000-00-00

Substance

BACLOFEN

Active strength

20 mg/1

Pharmacologic classes

GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC]

NDC exclude flag

No

Listing certified through

2019-12-31

Current FDA listing

Historical FDA.report record