Zyprexa

These highlights do not include all the information needed to use ZYPREXA safely and effectively. See full prescribing information for ZYPREXA. ZYPREXA (olanzapine) Tablet for Oral use ZYPREXA ZYDIS (olanzapine) Tablet, Orally Disintegrating for Oral use ZYPREXA IntraMuscular (olanzapine) Injection, Powder, For Solution for Intramuscular use Initial U.S. Approval: 1996

Approved

Approval ID

a3c9ea17-3793-494a-8b32-44e48f9f4503

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 1, 2010

Manufacturers

FDA

Rebel Distributors Corp

DUNS: 118802834

Products 3

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Olanzapine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code21695-142

Application NumberNDA020592

Product Classification

Marketing Category

C73594

Generic Name

Olanzapine

Product Specifications

Route of AdministrationORAL

Effective DateDecember 4, 2009

FDA Product Classification

INGREDIENTS (11)

OlanzapineActive

Quantity: 10 mg in 1 1

Code: N7U69T4SZR

Classification: ACTIB

Carnauba waxInactive

Code: R12CBM0EIZ

Classification: IACT

CrospovidoneInactive

Code: 68401960MK

Classification: IACT

Magnesium stearateInactive

Code: 70097M6I30

Classification: IACT

Hydroxypropyl celluloseInactive

Code: RFW2ET671P

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

LactoseInactive

Code: J2B2A4N98G

Classification: IACT

Titanium dioxideInactive

Code: 15FIX9V2JP

Classification: IACT

Cellulose, MicrocrystallineInactive

Code: OP1R32D61U

Classification: IACT

POLYETHYLENE GLYCOLInactive

Code: 3WJQ0SDW1A

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

Olanzapine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code21695-140

Application NumberNDA020592

Product Classification

Marketing Category

C73594

Generic Name

Olanzapine

Product Specifications

Route of AdministrationORAL

Effective DateDecember 4, 2009

FDA Product Classification

INGREDIENTS (11)

OlanzapineActive

Quantity: 5 mg in 1 1

Code: N7U69T4SZR

Classification: ACTIB

Carnauba waxInactive

Code: R12CBM0EIZ

Classification: IACT

Magnesium stearateInactive

Code: 70097M6I30

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

Hydroxypropyl celluloseInactive

Code: RFW2ET671P

Classification: IACT

LactoseInactive

Code: J2B2A4N98G

Classification: IACT

Cellulose, MicrocrystallineInactive

Code: OP1R32D61U

Classification: IACT

Titanium dioxideInactive

Code: 15FIX9V2JP

Classification: IACT

POLYETHYLENE GLYCOLInactive

Code: 3WJQ0SDW1A

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

CrospovidoneInactive

Code: 68401960MK

Classification: IACT

Olanzapine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code21695-144

Application NumberNDA020592

Product Classification

Marketing Category

C73594

Generic Name

Olanzapine

Product Specifications

Route of AdministrationORAL

Effective DateDecember 4, 2009

FDA Product Classification

INGREDIENTS (11)

Carnauba waxInactive

Code: R12CBM0EIZ

Classification: IACT

OlanzapineActive

Quantity: 20 mg in 1 1

Code: N7U69T4SZR

Classification: ACTIB

Hydroxypropyl celluloseInactive

Code: RFW2ET671P

Classification: IACT

LactoseInactive

Code: J2B2A4N98G

Classification: IACT

CrospovidoneInactive

Code: 68401960MK

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

Magnesium stearateInactive

Code: 70097M6I30

Classification: IACT

Cellulose, MicrocrystallineInactive

Code: OP1R32D61U

Classification: IACT

Titanium dioxideInactive

Code: 15FIX9V2JP

Classification: IACT

Ferric Oxide RedInactive

Code: 1K09F3G675

Classification: IACT

Polyethylene glycol 4000Inactive

Code: 4R4HFI6D95

Classification: IACT

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Zyprexa

Products 3

Olanzapine

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (11)

Olanzapine

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (11)

Olanzapine

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (11)

MedPath

Product

Company

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