BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE - bisoprolol fumarate and hydrochlorothiazide tablet, film coated 
Zydus Lifesciences Limited

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Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP

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

2.5 mg/6.25 mg

NDC 70771-1761-3

Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP 5 mg/6.25 mg

30 Tablets Unit-of-Use

Rx only

5 mg/6.25 mg

NDC 70771-1762-3

Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP 10 mg/6.25 mg

30 Tablets Unit-of-Use

Rx only

10 mg/6.25 mg
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 
bisoprolol fumarate and hydrochlorothiazide tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1760
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISOPROLOL FUMARATE (UNII: UR59KN573L) (BISOPROLOL - UNII:Y41JS2NL6U) BISOPROLOL FUMARATE2.5 mg
HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) HYDROCHLOROTHIAZIDE6.25 mg
Inactive Ingredients
Ingredient NameStrength
MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)  
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSPOVIDONE (35 .MU.M) (UNII: 40UAA97IT9)  
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Product Characteristics
ColorYELLOW (with occasional greyish to black speckles) Scoreno score
ShapeROUND (round) Size7mm
FlavorImprint Code 113
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1760-330 in 1 BOTTLE; Type 0: Not a Combination Product03/01/2023
2NDC:70771-1760-1100 in 1 BOTTLE; Type 0: Not a Combination Product03/01/2023
3NDC:70771-1760-5500 in 1 BOTTLE; Type 0: Not a Combination Product03/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21566603/01/2023
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 
bisoprolol fumarate and hydrochlorothiazide tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1761
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISOPROLOL FUMARATE (UNII: UR59KN573L) (BISOPROLOL - UNII:Y41JS2NL6U) BISOPROLOL FUMARATE5 mg
HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) HYDROCHLOROTHIAZIDE6.25 mg
Inactive Ingredients
Ingredient NameStrength
MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)  
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSPOVIDONE (35 .MU.M) (UNII: 40UAA97IT9)  
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
Product Characteristics
ColorPINK (light pink to pink) Scoreno score
ShapeROUND (round) Size7mm
FlavorImprint Code 114
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1761-330 in 1 BOTTLE; Type 0: Not a Combination Product03/01/2023
2NDC:70771-1761-1100 in 1 BOTTLE; Type 0: Not a Combination Product03/01/2023
3NDC:70771-1761-5500 in 1 BOTTLE; Type 0: Not a Combination Product03/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21566603/01/2023
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 
bisoprolol fumarate and hydrochlorothiazide tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1762
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISOPROLOL FUMARATE (UNII: UR59KN573L) (BISOPROLOL - UNII:Y41JS2NL6U) BISOPROLOL FUMARATE10 mg
HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) HYDROCHLOROTHIAZIDE6.25 mg
Inactive Ingredients
Ingredient NameStrength
MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)  
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSPOVIDONE (35 .MU.M) (UNII: 40UAA97IT9)  
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
Product Characteristics
ColorWHITE (with occasional greyish to black speckles) Scoreno score
ShapeROUND (round) Size7mm
FlavorImprint Code 115
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1762-330 in 1 BOTTLE; Type 0: Not a Combination Product03/01/2023
2NDC:70771-1762-1100 in 1 BOTTLE; Type 0: Not a Combination Product03/01/2023
3NDC:70771-1762-5500 in 1 BOTTLE; Type 0: Not a Combination Product03/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21566603/01/2023
Labeler - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited863362789ANALYSIS(70771-1760, 70771-1761, 70771-1762) , MANUFACTURE(70771-1760, 70771-1761, 70771-1762)

Revised: 11/2022
Document Id: 9d6e36f0-a9e4-4b66-997a-fd5f8e4e1cf7
Set id: 35ed3030-a9b3-4e4e-99cd-6d5c31ad22fa
Version: 1
Effective Time: 20221107
 
Zydus Lifesciences Limited