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 useInitial U.S. Approval: 2007
Approved
Approval ID
cb47560d-9e35-4b0f-b12b-6ea478684a5b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 1, 2023
Manufacturers
FDA
Glenmark Pharmaceuticals Inc., USA
DUNS: 130597813
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
nebivolol hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68462-616
Application NumberANDA203821
Product Classification
M
Marketing Category
C73584
G
Generic Name
nebivolol hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 1, 2023
FDA Product Classification
INGREDIENTS (12)
NEBIVOLOL HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: JGS34J7L9I
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSPOVIDONE (12 MPA.S AT 5%)Inactive
Code: 40UAA97IT9
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
nebivolol hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68462-618
Application NumberANDA203821
Product Classification
M
Marketing Category
C73584
G
Generic Name
nebivolol hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 1, 2023
FDA Product Classification
INGREDIENTS (11)
NEBIVOLOL HYDROCHLORIDEActive
Quantity: 20 mg in 1 1
Code: JGS34J7L9I
Classification: ACTIM
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSPOVIDONE (12 MPA.S AT 5%)Inactive
Code: 40UAA97IT9
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
nebivolol hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68462-617
Application NumberANDA203821
Product Classification
M
Marketing Category
C73584
G
Generic Name
nebivolol hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 1, 2023
FDA Product Classification
INGREDIENTS (12)
NEBIVOLOL HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: JGS34J7L9I
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
D&C RED NO. 27Inactive
Code: 2LRS185U6K
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONE (12 MPA.S AT 5%)Inactive
Code: 40UAA97IT9
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
nebivolol hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68462-615
Application NumberANDA203821
Product Classification
M
Marketing Category
C73584
G
Generic Name
nebivolol hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 1, 2023
FDA Product Classification
INGREDIENTS (11)
NEBIVOLOL HYDROCHLORIDEActive
Quantity: 2.5 mg in 1 1
Code: JGS34J7L9I
Classification: ACTIM
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONE (12 MPA.S AT 5%)Inactive
Code: 40UAA97IT9
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT