BISOPROLOL FUMARATE tablet, film coated

Bisoprolol Fumarate by

Drug Labeling and Warnings

Bisoprolol Fumarate by is a Prescription medication manufactured, distributed, or labeled by Zydus Lifesciences Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

BISOPROLOL FUMARATE 
bisoprolol fumarate tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1726
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISOPROLOL FUMARATE (UNII: UR59KN573L) (BISOPROLOL - UNII:Y41JS2NL6U)	BISOPROLOL FUMARATE	5 mg

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM OXIDE (UNII: LMI26O6933)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
CROSPOVIDONE (12 MPA.S AT 5%) (UNII: 40UAA97IT9)
D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)
FD&C RED NO. 40 (UNII: WZB9127XOA)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	PINK (light pink to pink)	Score	2 pieces
Shape	ROUND	Size	6mm
Flavor		Imprint Code	111
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1726-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	09/15/2022
2	NDC: 70771-1726-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/15/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA215680	09/15/2022

BISOPROLOL FUMARATE 
bisoprolol fumarate tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1727
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISOPROLOL FUMARATE (UNII: UR59KN573L) (BISOPROLOL - UNII:Y41JS2NL6U)	BISOPROLOL FUMARATE	10 mg

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
CROSPOVIDONE (12 MPA.S AT 5%) (UNII: 40UAA97IT9)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE (white to off white colored with occasional greyish)	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	112
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1727-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	09/15/2022
2	NDC: 70771-1727-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/15/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA215680	09/15/2022

Labeler - Zydus Lifesciences Limited (918596198)

Establishment
Name	Address	ID/FEI	Business Operations
Zydus Lifesciences Limited		863362789	ANALYSIS(70771-1726, 70771-1727) , MANUFACTURE(70771-1726, 70771-1727)