MedPath
FDA Product

Nebivolol

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

Basic Information

Nebivolol

62559-278

Regulatory Information

62559-278

ANDA203659

C73584

September 17, 2021

USA

These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . Initial U.S. Approval: 2007

HUMAN PRESCRIPTION DRUG LABEL

5

Company Information

145588013

Active Ingredients

NEBIVOLOL HYDROCHLORIDE

Quantity: 20 mg in 1 1

Code: JGS34J7L9I

Class Code: ACTIM

Inactive Ingredients

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

MICROCRYSTALLINE CELLULOSE 101

Code: 7T9FYH5QMK

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

HYPROMELLOSE 2910 (5 MPA.S)

Code: R75537T0T4

Class Code: IACT

MICROCRYSTALLINE CELLULOSE 102

Code: PNR0YF693Y

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

POLYSORBATE 80

Code: 6OZP39ZG8H

Class Code: IACT

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

MAGNESIUM PALMITOSTEARATE

Code: R4OXA9G5BV

Class Code: IACT

Active Moieties

NEBIVOLOL

Code: 030Y90569U

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