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
NDC Product Code70771-1762
Application NumberANDA215666
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateNovember 7, 2022
Generic Namebisoprolol fumarate and hydrochlorothiazide
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
NDC Product Code70771-1761
Application NumberANDA215666
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateNovember 7, 2022
Generic Namebisoprolol fumarate and hydrochlorothiazide
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
NDC Product Code70771-1760
Application NumberANDA215666
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateNovember 7, 2022
Generic Namebisoprolol fumarate and hydrochlorothiazide
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
