BISOPROLOL FUMARATE - bisoprolol fumarate tablet, film coated 
Zydus Lifesciences Limited

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Bisoprolol Fumarate Tablets, USP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1726-3

Bisoprolol Fumarate Tablets USP, 5 mg

30 Tablets

Unit-of-Use

Rx only

5 mg label

NDC 70771-1727-3

Bisoprolol Fumarate Tablets USP, 10 mg

30 Tablets

Unit-of-Use

Rx only

10 mg label
BISOPROLOL FUMARATE 
bisoprolol fumarate tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1726
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISOPROLOL FUMARATE (UNII: UR59KN573L) (BISOPROLOL - UNII:Y41JS2NL6U) BISOPROLOL FUMARATE5 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorPINK (light pink to pink) Score2 pieces
ShapeROUNDSize6mm
FlavorImprint Code 111
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1726-330 in 1 BOTTLE; Type 0: Not a Combination Product09/15/2022
2NDC:70771-1726-1100 in 1 BOTTLE; Type 0: Not a Combination Product09/15/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21568009/15/2022
BISOPROLOL FUMARATE 
bisoprolol fumarate tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1727
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISOPROLOL FUMARATE (UNII: UR59KN573L) (BISOPROLOL - UNII:Y41JS2NL6U) BISOPROLOL FUMARATE10 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITE (white to off white colored with occasional greyish) Scoreno score
ShapeROUNDSize7mm
FlavorImprint Code 112
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1727-330 in 1 BOTTLE; Type 0: Not a Combination Product09/15/2022
2NDC:70771-1727-1100 in 1 BOTTLE; Type 0: Not a Combination Product09/15/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21568009/15/2022
Labeler - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited863362789ANALYSIS(70771-1726, 70771-1727) , MANUFACTURE(70771-1726, 70771-1727)

Revised: 7/2022
Document Id: e6a69c5b-fe95-45b3-895f-259e4b49f6c5
Set id: 2d380e61-052c-4c33-8a35-01c9eb651d68
Version: 1
Effective Time: 20220726
 
Zydus Lifesciences Limited