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FDA Drug information

Bisoprolol Fumarate

Read time: 1 mins
Marketing start date: 23 Dec 2024
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Summary of product characteristics


Effective Time

20220726

Version

1

Spl Product Data Elements

Bisoprolol Fumarate Bisoprolol Fumarate BISOPROLOL FUMARATE BISOPROLOL ALUMINUM OXIDE ANHYDROUS DIBASIC CALCIUM PHOSPHATE BUTYLATED HYDROXYANISOLE CROSPOVIDONE (12 MPA.S AT 5%) D&C YELLOW NO. 10 ALUMINUM LAKE FD&C RED NO. 40 HYPROMELLOSE 2910 (6 MPA.S) MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 6000 SILICON DIOXIDE TITANIUM DIOXIDE light pink to pink 111 Bisoprolol Fumarate Bisoprolol Fumarate BISOPROLOL FUMARATE BISOPROLOL ANHYDROUS DIBASIC CALCIUM PHOSPHATE BUTYLATED HYDROXYANISOLE CROSPOVIDONE (12 MPA.S AT 5%) HYPROMELLOSE 2910 (6 MPA.S) MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 6000 SILICON DIOXIDE TITANIUM DIOXIDE white to off white colored with occasional greyish 112

Application Number

ANDA215680

Brand Name

Bisoprolol Fumarate

Generic Name

Bisoprolol Fumarate

Product Ndc

70771-1726

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1726-3 Bisoprolol Fumarate Tablets USP, 5 mg 30 Tablets Unit-of-Use Rx only NDC 70771-1727-3 Bisoprolol Fumarate Tablets USP, 10 mg 30 Tablets Unit-of-Use Rx only 5 mg label 10 mg label

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