Fluoxetine

Basic Information

Product Name

Fluoxetine

FDA Product Code

62332-242

Regulatory Information

NDC Product Code

62332-242

Application Number

ANDA208698

Marketing Category

C73584

Effective Date

August 1, 2023

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use FLUOXETINE TABLETS safely and effectively. See full prescribing information for FLUOXETINE TABLETS. FLUOXETINE tablets, for oral use Initial U.S. Approval: 1987

Labeling Type

Human Prescription Drug Label

Version Number

Active Ingredients

FLUOXETINE HYDROCHLORIDE

Quantity: 10 mg in 1 1

Code: I9W7N6B1KJ

Class Code: ACTIM

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

CROSPOVIDONE (120 .MU.M)

Code: 68401960MK

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

HYPROMELLOSE, UNSPECIFIED

Code: 3NXW29V3WO

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

POLYETHYLENE GLYCOL, UNSPECIFIED

Code: 3WJQ0SDW1A

Class Code: IACT

Active Moieties

Code: 01K63SUP8D

Fluoxetine

Basic Information

Regulatory Information

Company Information

Active Ingredients

MICROCRYSTALLINE CELLULOSE

CROSPOVIDONE (120 .MU.M)

STARCH, CORN

HYPROMELLOSE, UNSPECIFIED

SILICON DIOXIDE

MAGNESIUM STEARATE

TITANIUM DIOXIDE

POLYETHYLENE GLYCOL, UNSPECIFIED

Active Moieties

FLUOXETINE