BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE tablet, film coated

Bisoprolol Fumarate and Hydrochlorothiazide by

Drug Labeling and Warnings

Bisoprolol Fumarate and Hydrochlorothiazide 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: 70771-1760-3

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

INGREDIENTS AND APPEARANCE

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 
bisoprolol fumarate and hydrochlorothiazide tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1760
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISOPROLOL FUMARATE (UNII: UR59KN573L) (BISOPROLOL - UNII:Y41JS2NL6U)	BISOPROLOL FUMARATE	2.5 mg
HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)	HYDROCHLOROTHIAZIDE	6.25 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	YELLOW (with occasional greyish to black speckles)	Score	no score
Shape	ROUND (round)	Size	7mm
Flavor		Imprint Code	113
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1760-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2023
2	NDC: 70771-1760-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2023
3	NDC: 70771-1760-5	500 in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA215666	03/01/2023

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 
bisoprolol fumarate and hydrochlorothiazide tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1761
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
HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)	HYDROCHLOROTHIAZIDE	6.25 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	PINK (light pink to pink)	Score	no score
Shape	ROUND (round)	Size	7mm
Flavor		Imprint Code	114
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1761-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2023
2	NDC: 70771-1761-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2023
3	NDC: 70771-1761-5	500 in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA215666	03/01/2023

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 
bisoprolol fumarate and hydrochlorothiazide tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1762
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
HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)	HYDROCHLOROTHIAZIDE	6.25 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE (with occasional greyish to black speckles)	Score	no score
Shape	ROUND (round)	Size	7mm
Flavor		Imprint Code	115
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1762-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2023
2	NDC: 70771-1762-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2023
3	NDC: 70771-1762-5	500 in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA215666	03/01/2023

Labeler - Zydus Lifesciences Limited (918596198)

Establishment
Name	Address	ID/FEI	Business Operations
Zydus Lifesciences Limited		863362789	ANALYSIS(70771-1760, 70771-1761, 70771-1762) , MANUFACTURE(70771-1760, 70771-1761, 70771-1762)