Fluoxetine

Basic Information

Product Name

Fluoxetine

FDA Product Code

59651-308

Regulatory Information

NDC Product Code

59651-308

Application Number

ANDA213286

Marketing Category

C73584

Effective Date

January 25, 2024

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

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

CROSPOVIDONE (120 .MU.M)

Code: 68401960MK

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

HYPROMELLOSE 2910 (5 MPA.S)

Code: R75537T0T4

Class Code: IACT

MICROCRYSTALLINE CELLULOSE 102

Code: PNR0YF693Y

Class Code: IACT

POLYETHYLENE GLYCOL 400

Code: B697894SGQ

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

Active Moieties

Code: 01K63SUP8D

Fluoxetine

Basic Information

Regulatory Information

Company Information

Active Ingredients

STARCH, CORN

CROSPOVIDONE (120 .MU.M)

SILICON DIOXIDE

MAGNESIUM STEARATE

HYPROMELLOSE 2910 (5 MPA.S)

MICROCRYSTALLINE CELLULOSE 102

POLYETHYLENE GLYCOL 400

TITANIUM DIOXIDE

Active Moieties

FLUOXETINE