FDA Product

Baclofen

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

Baclofen

FDA Product Code

55154-7876

Regulatory Information

NDC Product Code

55154-7876

Application Number

ANDA077241

Marketing Category

C73584

Effective Date

May 30, 2017

Territorial Authority

USA

FDA Title

Baclofen Tablets, USP

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

7

Company Information

ManufacturerCardinal Health 107, LLC

DUNS Number

118546603

Active Ingredients

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

Quantity: 20 mg in 1 1

Code: H789N3FKE8

Class Code: ACTIB

Active Moieties

BACLOFEN

Code: H789N3FKE8

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