MedPath
FDA Product

Nebivolol

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Nebivolol

60687-652

Regulatory Information

60687-652

ANDA203828

C73584

June 20, 2023

USA

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

HUMAN PRESCRIPTION DRUG LABEL

2

Company Information

929561009

Active Ingredients

NEBIVOLOL HYDROCHLORIDE

Quantity: 10 mg in 1 1

Code: JGS34J7L9I

Class Code: ACTIM

Inactive Ingredients

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

FD&C BLUE NO. 2

Code: L06K8R7DQK

Class Code: IACT

D&C RED NO. 27

Code: 2LRS185U6K

Class Code: IACT

HYPROMELLOSE 2910 (15 MPA.S)

Code: 36SFW2JZ0W

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

POLYETHYLENE GLYCOL 6000

Code: 30IQX730WE

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

Active Moieties

NEBIVOLOL

Code: 030Y90569U

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