FDA Product

Bisoprolol Fumarate

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

Basic Information

Product Name

Bisoprolol Fumarate

FDA Product Code

71335-2178

Regulatory Information

NDC Product Code

71335-2178

Application Number

ANDA215563

Marketing Category

C73584

Effective Date

October 24, 2022

Territorial Authority

USA

FDA Title

Bisoprolol Fumarate Tablets, USP Rx Only

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

102

Company Information

ManufacturerBryant Ranch Prepack

DUNS Number

171714327

Active Ingredients

BISOPROLOL FUMARATE

Quantity: 5 mg in 1 1

Code: UR59KN573L

Class Code: ACTIB

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

FERROSOFERRIC OXIDE

Code: XM0M87F357

Class Code: IACT

ANHYDROUS DIBASIC CALCIUM PHOSPHATE

Code: L11K75P92J

Class Code: IACT

FERRIC OXIDE RED

Code: 1K09F3G675

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

Active Moieties

BISOPROLOL

Code: Y41JS2NL6U

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