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 useInitial U.S. Approval: 2007
Approved
Approval ID
673f5ad2-c09b-4a89-9407-efdadd007917
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 3, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 2
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 Code54868-5944
Application NumberNDA021742
Product Classification
M
Marketing Category
C73594
G
Generic Name
nebivolol hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 3, 2012
FDA Product Classification
INGREDIENTS (13)
nebivolol hydrochlorideActive
Quantity: 5 mg in 1 1
Code: JGS34J7L9I
Classification: ACTIM
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
D&C RED NO. 27Inactive
Code: 2LRS185U6K
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
hypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
nebivolol hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-6018
Application NumberNDA021742
Product Classification
M
Marketing Category
C73594
G
Generic Name
nebivolol hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 3, 2012
FDA Product Classification
INGREDIENTS (13)
nebivolol hydrochlorideActive
Quantity: 10 mg in 1 1
Code: JGS34J7L9I
Classification: ACTIM
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
D&C RED NO. 27Inactive
Code: 2LRS185U6K
Classification: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
hypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT