Fluoxetine

Basic Information

Product Name

Fluoxetine

FDA Product Code

71205-974

Regulatory Information

NDC Product Code

71205-974

Application Number

ANDA204597

Marketing Category

C73584

Effective Date

March 1, 2022

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use FLUOXETINE CAPSULES, safely and effectively. See full prescribing information for FLUOXETINE CAPSULES. FLUOXETINE capsules, 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

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

GELATIN, UNSPECIFIED

Code: 2G86QN327L

Class Code: IACT

FD&C RED NO. 3

Code: PN2ZH5LOQY

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

FD&C YELLOW NO. 6

Code: H77VEI93A8

Class Code: IACT

POTASSIUM HYDROXIDE

Code: WZH3C48M4T

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

SHELLAC

Code: 46N107B71O

Class Code: IACT

AMMONIA

Code: 5138Q19F1X

Class Code: IACT

FD&C BLUE NO. 1

Code: H3R47K3TBD

Class Code: IACT

FERROSOFERRIC OXIDE

Code: XM0M87F357

Class Code: IACT

Active Moieties

Code: 01K63SUP8D

Fluoxetine

Basic Information

Regulatory Information

Company Information

Active Ingredients

SILICON DIOXIDE

STARCH, CORN

SODIUM LAURYL SULFATE

GELATIN, UNSPECIFIED

FD&C RED NO. 3

TITANIUM DIOXIDE

FD&C YELLOW NO. 6

POTASSIUM HYDROXIDE

PROPYLENE GLYCOL

SHELLAC

AMMONIA

FD&C BLUE NO. 1

FERROSOFERRIC OXIDE

Active Moieties

Fluoxetine