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
fecef8fc-b66b-4133-b66f-8d6b72750622
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 7, 2023
Manufacturers
FDA
Ascend Laboratories, LLC
DUNS: 141250469
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 Code67877-390
Application NumberANDA203828
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nebivolol
Product Specifications
Route of AdministrationORAL
Effective DateJuly 13, 2023
FDA Product Classification
INGREDIENTS (10)
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
NEBIVOLOL HYDROCHLORIDEActive
Quantity: 20 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
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
Nebivolol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67877-391
Application NumberANDA203828
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nebivolol
Product Specifications
Route of AdministrationORAL
Effective DateJuly 13, 2023
FDA Product Classification
INGREDIENTS (11)
NEBIVOLOL HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: JGS34J7L9I
Classification: ACTIM
D&C RED NO. 27Inactive
Code: 2LRS185U6K
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
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
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
Nebivolol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67877-392
Application NumberANDA203828
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nebivolol
Product Specifications
Route of AdministrationORAL
Effective DateJuly 13, 2023
FDA Product Classification
INGREDIENTS (10)
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 YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Nebivolol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67877-393
Application NumberANDA203828
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nebivolol
Product Specifications
Route of AdministrationORAL
Effective DateJuly 13, 2023
FDA Product Classification
INGREDIENTS (10)
NEBIVOLOL HYDROCHLORIDEActive
Quantity: 2.5 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
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
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