Bisoprolol Fumarate and Hydrochlorothiazide
Bisoprolol Fumarate and Hydrochlorothiazide Tablets
Approved
Approval ID
ec524b62-3b42-4c36-bca6-7ef442fcd477
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 15, 2011
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-4577
Application NumberANDA075579
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 15, 2011
Generic NameBisoprolol Fumarate and Hydrochlorothiazide
INGREDIENTS (12)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
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
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
Bisoprolol Fumarate and Hydrochlorothiazide
PRODUCT DETAILS
NDC Product Code54868-4578
Application NumberANDA075579
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 15, 2011
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
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Bisoprolol Fumarate and Hydrochlorothiazide
PRODUCT DETAILS
NDC Product Code54868-4576
Application NumberANDA075579
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 15, 2011
Generic NameBisoprolol Fumarate and Hydrochlorothiazide
INGREDIENTS (13)
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
BISOPROLOL FUMARATEActive
Quantity: 5 mg in 1 1
Code: UR59KN573L
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYDROCHLOROTHIAZIDEActive
Quantity: 6.25 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT