nebivolol

Basic Information

Product Name

nebivolol

FDA Product Code

0904-7189

Regulatory Information

NDC Product Code

0904-7189

Application Number

ANDA203966

Marketing Category

C73584

Effective Date

February 14, 2022

Territorial Authority

USA

FDA Title

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

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

HYPROMELLOSE 2910 (6 MPA.S)

Code: 0WZ8WG20P6

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

FD&C BLUE NO. 2

Code: L06K8R7DQK

Class Code: IACT

FD&C YELLOW NO. 6

Code: H77VEI93A8

Class Code: IACT

NEBIVOLOL HYDROCHLORIDE

Quantity: 5 mg in 1 1

Code: JGS34J7L9I

Class Code: ACTIM

Active Moieties

Code: 030Y90569U

nebivolol

Basic Information

Regulatory Information

Company Information

Active Ingredients

LACTOSE MONOHYDRATE

CROSCARMELLOSE SODIUM

HYPROMELLOSE 2910 (6 MPA.S)

MICROCRYSTALLINE CELLULOSE

MAGNESIUM STEARATE

STARCH, CORN

FD&C BLUE NO. 2

FD&C YELLOW NO. 6

Active Moieties

NEBIVOLOL