OLANZAPINE
These highlights do not include all the information needed to use OLANZAPINE safely and effectively. See full prescribing information for OLANZAPINE. OLANZAPINE tablets USP, for oral use OLANZAPINE orally disintegrating tablets, USP for oral use Initial U.S. Approval: 1996
Approved
Approval ID
98697cfd-5521-f8a9-af17-555031690b08
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 7, 2023
Manufacturers
FDA
AvPAK
DUNS: 832926666
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 Code50268-616
Application NumberANDA091415
Product Classification
M
Marketing Category
C73584
G
Generic Name
OLANZAPINE
Product Specifications
Route of AdministrationORAL
Effective DateNovember 7, 2023
FDA Product Classification
INGREDIENTS (6)
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
OLANZAPINEActive
Quantity: 10 mg in 1 1
Code: N7U69T4SZR
Classification: ACTIB
OLANZAPINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50268-615
Application NumberANDA091415
Product Classification
M
Marketing Category
C73584
G
Generic Name
OLANZAPINE
Product Specifications
Route of AdministrationORAL
Effective DateNovember 7, 2023
FDA Product Classification
INGREDIENTS (6)
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
OLANZAPINEActive
Quantity: 5 mg in 1 1
Code: N7U69T4SZR
Classification: ACTIB
OLANZAPINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50268-617
Application NumberANDA091415
Product Classification
M
Marketing Category
C73584
G
Generic Name
OLANZAPINE
Product Specifications
Route of AdministrationORAL
Effective DateNovember 7, 2023
FDA Product Classification
INGREDIENTS (6)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
OLANZAPINEActive
Quantity: 15 mg in 1 1
Code: N7U69T4SZR
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT