Olanzapine and Fluoxetine

Basic Information

Product Name

FDA Product Code

42291-652

Regulatory Information

NDC Product Code

42291-652

Application Number

ANDA202074

Marketing Category

C73584

Effective Date

January 10, 2024

Territorial Authority

USA

FDA Title

Olanzapine and Fluoxetine Capsules USP Rx Only These highlights do not include all the information needed to use OLANZAPINE AND FLUOXETINE CAPSULES safely and effectively. See full prescribing information for OLANZAPINE AND FLUOXETINE CAPSULES. OLANZAPINE and FLUOXETINE capsules, for oral use Initial U.S. Approval: 2003

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

FD&C BLUE NO. 2

Code: L06K8R7DQK

Class Code: IACT

FD&C BLUE NO. 1

Code: H3R47K3TBD

Class Code: IACT

D&C YELLOW NO. 10

Code: 35SW5USQ3G

Class Code: IACT

INDIGOTINDISULFONATE SODIUM

Code: D3741U8K7L

Class Code: IACT

FERROSOFERRIC OXIDE

Code: XM0M87F357

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

FD&C RED NO. 40

Code: WZB9127XOA

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

GELATIN, UNSPECIFIED

Code: 2G86QN327L

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

SHELLAC

Code: 46N107B71O

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

FD&C YELLOW NO. 6

Code: H77VEI93A8

Class Code: IACT

OLANZAPINE

Quantity: 3 mg in 1 1

Code: N7U69T4SZR

Class Code: ACTIB

FLUOXETINE HYDROCHLORIDE

Quantity: 25 mg in 1 1

Code: I9W7N6B1KJ

Class Code: ACTIM

Active Moieties

OLANZAPINE

Code: N7U69T4SZR

FLUOXETINE

Code: 01K63SUP8D

Basic Information

Regulatory Information

Company Information

Active Ingredients

FD&C BLUE NO. 2

FD&C BLUE NO. 1

D&C YELLOW NO. 10

INDIGOTINDISULFONATE SODIUM

FERROSOFERRIC OXIDE

STARCH, CORN

FD&C RED NO. 40

PROPYLENE GLYCOL

GELATIN, UNSPECIFIED

MAGNESIUM STEARATE

SHELLAC

TITANIUM DIOXIDE

FD&C YELLOW NO. 6

Active Moieties

OLANZAPINE

FLUOXETINE