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
66ef201f-85eb-44f0-9ef0-1b618c6e0bff
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 30, 2009
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-3941
Application NumberNDA020592
Product Classification
M
Marketing Category
C73594
G
Generic Name
Olanzapine
Product Specifications
Route of AdministrationORAL
Effective DateNovember 30, 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
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
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
Olanzapine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4255
Application NumberNDA020592
Product Classification
M
Marketing Category
C73594
G
Generic Name
Olanzapine
Product Specifications
Route of AdministrationORAL
Effective DateNovember 30, 2009
FDA Product Classification
INGREDIENTS (11)
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
HYPROMELLOSEInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
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
Olanzapine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4254
Application NumberNDA020592
Product Classification
M
Marketing Category
C73594
G
Generic Name
Olanzapine
Product Specifications
Route of AdministrationORAL
Effective DateNovember 30, 2009
FDA Product Classification
INGREDIENTS (11)
OLANZAPINEActive
Quantity: 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
HYPROMELLOSEInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
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
Olanzapine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5336
Application NumberNDA020592
Product Classification
M
Marketing Category
C73594
G
Generic Name
Olanzapine
Product Specifications
Route of AdministrationORAL
Effective DateNovember 30, 2009
FDA Product Classification
INGREDIENTS (11)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
OLANZAPINEActive
Quantity: 7.5 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
HYPROMELLOSEInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT