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FDA Drug information

Bisoprolol Fumarate and Hydrochlorothiazide

Read time: 1 mins
Marketing start date: 27 Apr 2024
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Summary of product characteristics


Effective Time

20221107

Version

1

Spl Product Data Elements

Bisoprolol Fumarate and Hydrochlorothiazide bisoprolol fumarate and hydrochlorothiazide BISOPROLOL FUMARATE BISOPROLOL HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE MICROCRYSTALLINE CELLULOSE 102 BUTYLATED HYDROXYANISOLE ANHYDROUS DIBASIC CALCIUM PHOSPHATE MAGNESIUM STEARATE SILICON DIOXIDE CROSPOVIDONE (35 .MU.M) HYPROMELLOSE 2910 (6 MPA.S) TITANIUM DIOXIDE POLYETHYLENE GLYCOL 8000 FERRIC OXIDE YELLOW FERRIC OXIDE RED with occasional greyish to black speckles round 113 Bisoprolol Fumarate and Hydrochlorothiazide bisoprolol fumarate and hydrochlorothiazide BISOPROLOL FUMARATE BISOPROLOL HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE MICROCRYSTALLINE CELLULOSE 102 BUTYLATED HYDROXYANISOLE ANHYDROUS DIBASIC CALCIUM PHOSPHATE MAGNESIUM STEARATE SILICON DIOXIDE CROSPOVIDONE (35 .MU.M) HYPROMELLOSE 2910 (6 MPA.S) TITANIUM DIOXIDE POLYETHYLENE GLYCOL 8000 FD&C RED NO. 40 D&C YELLOW NO. 10 ALUMINUM LAKE ALUMINUM OXIDE light pink to pink round 114 Bisoprolol Fumarate and Hydrochlorothiazide bisoprolol fumarate and hydrochlorothiazide BISOPROLOL FUMARATE BISOPROLOL HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE MICROCRYSTALLINE CELLULOSE 102 BUTYLATED HYDROXYANISOLE ANHYDROUS DIBASIC CALCIUM PHOSPHATE MAGNESIUM STEARATE SILICON DIOXIDE CROSPOVIDONE (35 .MU.M) HYPROMELLOSE 2910 (6 MPA.S) TITANIUM DIOXIDE POLYETHYLENE GLYCOL 8000 with occasional greyish to black speckles round 115

Application Number

ANDA215666

Brand Name

Bisoprolol Fumarate and Hydrochlorothiazide

Generic Name

bisoprolol fumarate and hydrochlorothiazide

Product Ndc

70771-1760

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1760-3 Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP 2.5 mg/6.25 mg 30 Tablets Unit-of-Use Rx only NDC 70771-1761-3 Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP 5 mg/6.25 mg 30 Tablets Unit-of-Use Rx only NDC 70771-1762-3 Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP 10 mg/6.25 mg 30 Tablets Unit-of-Use Rx only 2.5 mg/6.25 mg 5 mg/6.25 mg 10 mg/6.25 mg

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