BISOPROLOL FUMARATE
BISOPROLOL FUMARATE Tablets, USP Rx only
Approved
Approval ID
ae10b8e1-557d-4437-8a1d-89d7844122c8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 7, 2023
Manufacturers
FDA
Alembic Pharmaceuticals Limited
DUNS: 650574663
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 Code46708-603
Application NumberANDA204891
Product Classification
M
Marketing Category
C73584
G
Generic Name
BISOPROLOL FUMARATE
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 7, 2023
FDA Product Classification
INGREDIENTS (11)
BISOPROLOL FUMARATEActive
Quantity: 5 mg in 1 1
Code: UR59KN573L
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
BISOPROLOL FUMARATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code46708-604
Application NumberANDA204891
Product Classification
M
Marketing Category
C73584
G
Generic Name
BISOPROLOL FUMARATE
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 7, 2023
FDA Product Classification
INGREDIENTS (11)
BISOPROLOL FUMARATEActive
Quantity: 10 mg in 1 1
Code: UR59KN573L
Classification: ACTIB
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT