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
71c6577c-ffea-4934-bc10-2d35942f8a16
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 4, 2011
Manufacturers
FDA
Dispensing Solutions, Inc.
DUNS: 066070785
Products 4
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 Code68258-7093
Application NumberNDA020592
Product Classification
M
Marketing Category
C73594
G
Generic Name
Olanzapine
Product Specifications
Route of AdministrationORAL
Effective DateOctober 4, 2011
FDA Product Classification
INGREDIENTS (10)
OlanzapineActive
Quantity: 15 mg in 1 1
Code: N7U69T4SZR
Classification: ACTIB
Carnauba waxInactive
Code: R12CBM0EIZ
Classification: IACT
CrospovidoneInactive
Code: 68401960MK
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
Hydroxypropyl celluloseInactive
Code: RFW2ET671P
Classification: IACT
LactoseInactive
Code: J2B2A4N98G
Classification: IACT
Cellulose, MicrocrystallineInactive
Code: OP1R32D61U
Classification: IACT
Magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
TriacetinInactive
Code: XHX3C3X673
Classification: IACT
Titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Olanzapine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68258-7091
Application NumberNDA020592
Product Classification
M
Marketing Category
C73594
G
Generic Name
Olanzapine
Product Specifications
Route of AdministrationORAL
Effective DateOctober 4, 2011
FDA Product Classification
INGREDIENTS (11)
Carnauba waxInactive
Code: R12CBM0EIZ
Classification: IACT
CrospovidoneInactive
Code: 68401960MK
Classification: IACT
OlanzapineActive
Quantity: 5 mg in 1 1
Code: N7U69T4SZR
Classification: ACTIB
Hydroxypropyl celluloseInactive
Code: RFW2ET671P
Classification: IACT
LactoseInactive
Code: J2B2A4N98G
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
Magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
Cellulose, MicrocrystallineInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
Titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
Olanzapine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68258-7090
Application NumberNDA020592
Product Classification
M
Marketing Category
C73594
G
Generic Name
Olanzapine
Product Specifications
Route of AdministrationORAL
Effective DateOctober 4, 2011
FDA Product Classification
INGREDIENTS (11)
Titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
OlanzapineActive
Quantity: 2.5 mg in 1 1
Code: N7U69T4SZR
Classification: ACTIB
Carnauba waxInactive
Code: R12CBM0EIZ
Classification: IACT
CrospovidoneInactive
Code: 68401960MK
Classification: IACT
Hydroxypropyl celluloseInactive
Code: RFW2ET671P
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
LactoseInactive
Code: J2B2A4N98G
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
Magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
Cellulose, MicrocrystallineInactive
Code: OP1R32D61U
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
Olanzapine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68258-7092
Application NumberNDA020592
Product Classification
M
Marketing Category
C73594
G
Generic Name
Olanzapine
Product Specifications
Route of AdministrationORAL
Effective DateOctober 4, 2011
FDA Product Classification
INGREDIENTS (11)
Carnauba waxInactive
Code: R12CBM0EIZ
Classification: IACT
CrospovidoneInactive
Code: 68401960MK
Classification: IACT
OlanzapineActive
Quantity: 10 mg in 1 1
Code: N7U69T4SZR
Classification: ACTIB
Hydroxypropyl celluloseInactive
Code: RFW2ET671P
Classification: IACT
Magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
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