Nebivolol Hydrochloride
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
b1762bbb-b5be-48a7-8101-bb736f28845a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 11, 2023
Manufacturers
FDA
Unichem Pharmaceuticals (USA), Inc.
DUNS: 181620514
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 Code29300-375
Application NumberANDA213830
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nebivolol Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 11, 2023
FDA Product Classification
INGREDIENTS (11)
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
NEBIVOLOL HYDROCHLORIDEActive
Quantity: 2.5 mg in 1 1
Code: JGS34J7L9I
Classification: ACTIM
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
Nebivolol Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code29300-378
Application NumberANDA213830
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nebivolol Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 11, 2023
FDA Product Classification
INGREDIENTS (10)
NEBIVOLOL HYDROCHLORIDEActive
Quantity: 20 mg in 1 1
Code: JGS34J7L9I
Classification: ACTIM
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
Nebivolol Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code29300-376
Application NumberANDA213830
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nebivolol Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 11, 2023
FDA Product Classification
INGREDIENTS (11)
NEBIVOLOL HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: JGS34J7L9I
Classification: ACTIM
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
Nebivolol Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code29300-377
Application NumberANDA213830
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nebivolol Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 11, 2023
FDA Product Classification
INGREDIENTS (11)
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
NEBIVOLOL HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: JGS34J7L9I
Classification: ACTIM
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT