Olanzapine
These highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets for oral use Initial U.S. Approval: 1996
Approved
Approval ID
ea3259d5-36ee-4ac9-b849-9625626e2187
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 17, 2023
Manufacturers
FDA
NorthStar RxLLC
DUNS: 830546433
Products 6
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 Code72603-159
Application NumberANDA202862
Product Classification
M
Marketing Category
C73584
G
Generic Name
Olanzapine
Product Specifications
Route of AdministrationORAL
Effective DateAugust 17, 2023
FDA Product Classification
INGREDIENTS (7)
OLANZAPINEActive
Quantity: 20 mg in 1 1
Code: N7U69T4SZR
Classification: ACTIB
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
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
Olanzapine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72603-157
Application NumberANDA202862
Product Classification
M
Marketing Category
C73584
G
Generic Name
Olanzapine
Product Specifications
Route of AdministrationORAL
Effective DateAugust 17, 2023
FDA Product Classification
INGREDIENTS (6)
OLANZAPINEActive
Quantity: 10 mg in 1 1
Code: N7U69T4SZR
Classification: ACTIB
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Olanzapine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72603-155
Application NumberANDA202862
Product Classification
M
Marketing Category
C73584
G
Generic Name
Olanzapine
Product Specifications
Route of AdministrationORAL
Effective DateAugust 17, 2023
FDA Product Classification
INGREDIENTS (6)
OLANZAPINEActive
Quantity: 5 mg in 1 1
Code: N7U69T4SZR
Classification: ACTIB
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
Olanzapine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72603-156
Application NumberANDA202862
Product Classification
M
Marketing Category
C73584
G
Generic Name
Olanzapine
Product Specifications
Route of AdministrationORAL
Effective DateAugust 17, 2023
FDA Product Classification
INGREDIENTS (6)
OLANZAPINEActive
Quantity: 7.5 mg in 1 1
Code: N7U69T4SZR
Classification: ACTIB
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
Olanzapine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72603-154
Application NumberANDA202862
Product Classification
M
Marketing Category
C73584
G
Generic Name
Olanzapine
Product Specifications
Route of AdministrationORAL
Effective DateAugust 17, 2023
FDA Product Classification
INGREDIENTS (6)
OLANZAPINEActive
Quantity: 2.5 mg in 1 1
Code: N7U69T4SZR
Classification: ACTIB
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
Olanzapine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72603-158
Application NumberANDA202862
Product Classification
M
Marketing Category
C73584
G
Generic Name
Olanzapine
Product Specifications
Route of AdministrationORAL
Effective DateAugust 17, 2023
FDA Product Classification
INGREDIENTS (7)
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
OLANZAPINEActive
Quantity: 15 mg in 1 1
Code: N7U69T4SZR
Classification: ACTIB
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT