Bisoprolol Fumarate
Bisoprolol Fumarate Tablets, USP
Approved
Approval ID
3c393b41-9423-4ea6-8a79-0cbff0693471
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 10, 2023
Manufacturers
FDA
Viona Pharmaceuticals Inc
DUNS: 081468959
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Bisoprolol Fumarate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72578-112
Application NumberANDA215680
Product Classification
M
Marketing Category
C73584
G
Generic Name
Bisoprolol Fumarate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 10, 2023
FDA Product Classification
INGREDIENTS (10)
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
BISOPROLOL FUMARATEActive
Quantity: 10 mg in 1 1
Code: UR59KN573L
Classification: ACTIB
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
CROSPOVIDONE (12 MPA.S AT 5%)Inactive
Code: 40UAA97IT9
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
Bisoprolol Fumarate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72578-111
Application NumberANDA215680
Product Classification
M
Marketing Category
C73584
G
Generic Name
Bisoprolol Fumarate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 10, 2023
FDA Product Classification
INGREDIENTS (13)
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
BISOPROLOL FUMARATEActive
Quantity: 5 mg in 1 1
Code: UR59KN573L
Classification: ACTIB
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
D&C YELLOW NO. 10 ALUMINUM LAKEInactive
Code: CQ3XH3DET6
Classification: IACT
CROSPOVIDONE (12 MPA.S AT 5%)Inactive
Code: 40UAA97IT9
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT