Bystolic
These highlights do not include all the information needed to use BYSTOLIC safely and effectively. See full prescribing information for BYSTOLIC. BYSTOLIC (nebivolol) tablets, for oral use Initial U.S. Approval: 2007
Approved
Approval ID
07ed02ff-523f-437e-bddc-5c41a4bb0062
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 1, 2014
Manufacturers
FDA
Carilion Materials Management
DUNS: 079239644
Products 1
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 Code68151-5135
Application NumberNDA021742
Product Classification
M
Marketing Category
C73594
G
Generic Name
nebivolol hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 1, 2014
FDA Product Classification
INGREDIENTS (13)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
nebivolol hydrochlorideActive
Quantity: 10 mg in 1 1
Code: JGS34J7L9I
Classification: ACTIM
D&C RED NO. 27Inactive
Code: 2LRS185U6K
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT