MedPath
FDA Product

Nebivolol

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

Basic Information

Nebivolol

70756-292

Regulatory Information

70756-292

ANDA216172

C73584

July 13, 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

5

Company Information

080268943

Active Ingredients

NEBIVOLOL HYDROCHLORIDE

Quantity: 10 mg in 1 1

Code: JGS34J7L9I

Class Code: ACTIM

Inactive Ingredients

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

D&C RED NO. 27 ALUMINUM LAKE

Code: ZK64F7XSTX

Class Code: IACT

HYPROMELLOSE 2910 (15 MPA.S)

Code: 36SFW2JZ0W

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

POLYSORBATE 80

Code: 6OZP39ZG8H

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

FD&C BLUE NO. 2--ALUMINUM LAKE

Code: 4AQJ3LG584

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

Active Moieties

NEBIVOLOL

Code: 030Y90569U

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