MedPath
FDA Product

Fluoxetine

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

Basic Information

Fluoxetine

63187-218

Regulatory Information

63187-218

ANDA075872

C73584

October 1, 2022

USA

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

HUMAN PRESCRIPTION DRUG LABEL

4

Company Information

Proficient Rx LP

079196022

Active Ingredients

FLUOXETINE HYDROCHLORIDE

Quantity: 10 mg in 1 1

Code: I9W7N6B1KJ

Class Code: ACTIM

D&C YELLOW NO. 10

Code: 35SW5USQ3G

Class Code: IACT

FD&C BLUE NO. 2

Code: L06K8R7DQK

Class Code: IACT

ALUMINUM OXIDE

Code: LMI26O6933

Class Code: IACT

FD&C YELLOW NO. 6

Code: H77VEI93A8

Class Code: IACT

HYPROMELLOSE 2910 (5 MPA.S)

Code: R75537T0T4

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

POVIDONE K30

Code: U725QWY32X

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

INDIGOTINDISULFONATE SODIUM

Code: D3741U8K7L

Class Code: IACT

POLYETHYLENE GLYCOL 6000

Code: 30IQX730WE

Class Code: IACT

POLYETHYLENE GLYCOL 8000

Code: Q662QK8M3B

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

Active Moieties

FLUOXETINE

Code: 01K63SUP8D

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