Bisoprolol Fumarate and Hydrochlorothiazide
Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP
Approved
Approval ID
35ed3030-a9b3-4e4e-99cd-6d5c31ad22fa
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 7, 2022
Manufacturers
FDA
Zydus Lifesciences Limited
DUNS: 918596198
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
bisoprolol fumarate and hydrochlorothiazide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70771-1762
Application NumberANDA215666
Product Classification
M
Marketing Category
C73584
G
Generic Name
bisoprolol fumarate and hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateNovember 7, 2022
FDA Product Classification
INGREDIENTS (11)
BISOPROLOL FUMARATEActive
Quantity: 10 mg in 1 1
Code: UR59KN573L
Classification: ACTIB
HYDROCHLOROTHIAZIDEActive
Quantity: 6.25 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSPOVIDONE (35 .MU.M)Inactive
Code: 40UAA97IT9
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
bisoprolol fumarate and hydrochlorothiazide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70771-1761
Application NumberANDA215666
Product Classification
M
Marketing Category
C73584
G
Generic Name
bisoprolol fumarate and hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateNovember 7, 2022
FDA Product Classification
INGREDIENTS (14)
BISOPROLOL FUMARATEActive
Quantity: 5 mg in 1 1
Code: UR59KN573L
Classification: ACTIB
HYDROCHLOROTHIAZIDEActive
Quantity: 6.25 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONE (35 .MU.M)Inactive
Code: 40UAA97IT9
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
D&C YELLOW NO. 10 ALUMINUM LAKEInactive
Code: CQ3XH3DET6
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
bisoprolol fumarate and hydrochlorothiazide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70771-1760
Application NumberANDA215666
Product Classification
M
Marketing Category
C73584
G
Generic Name
bisoprolol fumarate and hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateNovember 7, 2022
FDA Product Classification
INGREDIENTS (13)
HYDROCHLOROTHIAZIDEActive
Quantity: 6.25 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
BISOPROLOL FUMARATEActive
Quantity: 2.5 mg in 1 1
Code: UR59KN573L
Classification: ACTIB
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
CROSPOVIDONE (35 .MU.M)Inactive
Code: 40UAA97IT9
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 11/7/2022
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
