Nebivolol
These highlights do not include all the information needed to use NEBIVOLOL TABLETS safely and effectively. See full prescribing information for NEBIVOLOL TABLETS. NEBIVOLOL tablets, for oral use Initial U.S. Approval: 2007
Approved
Approval ID
19d20396-ade8-400e-94f4-69913637d051
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 9, 2023
Manufacturers
FDA
Modavar Pharmaceuticals LLC
DUNS: 858949204
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Nebivolol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72241-032
Application NumberANDA208717
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nebivolol
Product Specifications
Route of AdministrationORAL
Effective DateNovember 9, 2023
FDA Product Classification
INGREDIENTS (10)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
NEBIVOLOL HYDROCHLORIDEActive
Quantity: 2.5 mg in 1 1
Code: JGS34J7L9I
Classification: ACTIM
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
Nebivolol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72241-034
Application NumberANDA208717
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nebivolol
Product Specifications
Route of AdministrationORAL
Effective DateNovember 9, 2023
FDA Product Classification
INGREDIENTS (10)
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
NEBIVOLOL HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: JGS34J7L9I
Classification: ACTIM
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Nebivolol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72241-035
Application NumberANDA208717
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nebivolol
Product Specifications
Route of AdministrationORAL
Effective DateNovember 9, 2023
FDA Product Classification
INGREDIENTS (10)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
NEBIVOLOL HYDROCHLORIDEActive
Quantity: 20 mg in 1 1
Code: JGS34J7L9I
Classification: ACTIM
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
Nebivolol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72241-033
Application NumberANDA208717
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nebivolol
Product Specifications
Route of AdministrationORAL
Effective DateNovember 9, 2023
FDA Product Classification
INGREDIENTS (10)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
NEBIVOLOL HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: JGS34J7L9I
Classification: ACTIM
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT