OLANZAPINE

Basic Information

Product Name

OLANZAPINE

FDA Product Code

13668-089

Regulatory Information

NDC Product Code

13668-089

Application Number

ANDA091415

Marketing Category

C73584

Effective Date

December 8, 2022

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use OLANZAPINE safely and effectively. See full prescribing information for OLANZAPINE. OLANZAPINE tablets, for oral use OLANZAPINE orally disintegrating tablets, for oral use Initial U.S. Approval: 1996

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

ASPARTAME

Code: Z0H242BBR1

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

CROSPOVIDONE

Code: 2S7830E561

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

OLANZAPINE

Quantity: 15 mg in 1 1

Code: N7U69T4SZR

Class Code: ACTIB

MANNITOL

Code: 3OWL53L36A

Class Code: IACT

Active Moieties

Code: N7U69T4SZR

OLANZAPINE

Basic Information

Regulatory Information

Company Information

Active Ingredients

ASPARTAME

CELLULOSE, MICROCRYSTALLINE

CROSPOVIDONE

MAGNESIUM STEARATE

MANNITOL

Active Moieties

OLANZAPINE