Nebivolol

Basic Information

Product Name

Nebivolol

FDA Product Code

31722-586

Regulatory Information

NDC Product Code

31722-586

Application Number

ANDA203825

Marketing Category

C73584

Effective Date

January 31, 2024

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 use Initial U.S. Approval: 2007

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

HYPROMELLOSE 2910 (5 MPA.S)

Code: R75537T0T4

Class Code: IACT

FD&C YELLOW NO. 6

Code: H77VEI93A8

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

NEBIVOLOL HYDROCHLORIDE

Quantity: 5 mg in 1 1

Code: JGS34J7L9I

Class Code: ACTIM

MICROCRYSTALLINE CELLULOSE 102

Code: PNR0YF693Y

Class Code: IACT

Active Moieties

Code: 030Y90569U

Nebivolol

Basic Information

Regulatory Information

Company Information

Active Ingredients

SILICON DIOXIDE

CROSCARMELLOSE SODIUM

HYPROMELLOSE 2910 (5 MPA.S)

FD&C YELLOW NO. 6

LACTOSE MONOHYDRATE

MAGNESIUM STEARATE

MICROCRYSTALLINE CELLULOSE 102

Active Moieties

NEBIVOLOL