Baclofen

Product NDC

49999-607

11-digit product format

499990607

Labeler code

49999

Product ID

49999-607_38d135c0-0089-458f-880c-c298c4f77552

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Baclofen

Dosage form

TABLET

Route

ORAL

Labeler

Lake Erie Medical DBA Quality Care Products LLC

Application

ANDA074584

Marketing category

ANDA

Marketing start

2010-05-19

Marketing end

0000-00-00

Substance

BACLOFEN

Active strength

10 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

2020-12-31

Current FDA listing

Historical FDA.report record