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FDA Product

bisoprolol fumarate and hydrochlorothiazide

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

Basic Information

bisoprolol fumarate and hydrochlorothiazide

71335-1161

Regulatory Information

71335-1161

ANDA079106

C73584

February 11, 2022

USA

Bisoprolol Fumarate and Hydrochlorothiazide Tablets USP

HUMAN PRESCRIPTION DRUG LABEL

100

Company Information

171714327

Active Ingredients

HYDROCHLOROTHIAZIDE

Quantity: 6.25 mg in 1 1

Code: 0J48LPH2TH

Class Code: ACTIB

ANHYDROUS DIBASIC CALCIUM PHOSPHATE

Code: L11K75P92J

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

COPOVIDONE K25-31

Code: D9C330MD8B

Class Code: IACT

HYPROMELLOSE 2910 (5 MPA.S)

Code: R75537T0T4

Class Code: IACT

BISOPROLOL FUMARATE

Quantity: 2.5 mg in 1 1

Code: UR59KN573L

Class Code: ACTIB

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

POLYETHYLENE GLYCOL 6000

Code: 30IQX730WE

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

Active Moieties

BISOPROLOL

Code: Y41JS2NL6U

HYDROCHLOROTHIAZIDE

Code: 0J48LPH2TH

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