Olanzapine
HIGHLIGHTS OF PRESCRIBING INFORMATION 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
5b7d091a-7e7a-46ac-ab13-49ef27b1b0a5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 14, 2020
Manufacturers
FDA
Indoco Remedies Limited
DUNS: 650445950
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 Code14445-109
Application NumberANDA206155
Product Classification
M
Marketing Category
C73584
G
Generic Name
Olanzapine
Product Specifications
Route of AdministrationORAL
Effective DateAugust 14, 2020
FDA Product Classification
INGREDIENTS (12)
OLANZAPINEActive
Quantity: 10 mg in 1 1
Code: N7U69T4SZR
Classification: ACTIB
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
Olanzapine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code14445-111
Application NumberANDA206155
Product Classification
M
Marketing Category
C73584
G
Generic Name
Olanzapine
Product Specifications
Route of AdministrationORAL
Effective DateAugust 14, 2020
FDA Product Classification
INGREDIENTS (13)
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
OLANZAPINEActive
Quantity: 20 mg in 1 1
Code: N7U69T4SZR
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
Olanzapine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code14445-110
Application NumberANDA206155
Product Classification
M
Marketing Category
C73584
G
Generic Name
Olanzapine
Product Specifications
Route of AdministrationORAL
Effective DateAugust 14, 2020
FDA Product Classification
INGREDIENTS (12)
OLANZAPINEActive
Quantity: 15 mg in 1 1
Code: N7U69T4SZR
Classification: ACTIB
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
Olanzapine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code14445-106
Application NumberANDA206155
Product Classification
M
Marketing Category
C73584
G
Generic Name
Olanzapine
Product Specifications
Route of AdministrationORAL
Effective DateAugust 14, 2020
FDA Product Classification
INGREDIENTS (12)
OLANZAPINEActive
Quantity: 2.5 mg in 1 1
Code: N7U69T4SZR
Classification: ACTIB
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
Olanzapine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code14445-108
Application NumberANDA206155
Product Classification
M
Marketing Category
C73584
G
Generic Name
Olanzapine
Product Specifications
Route of AdministrationORAL
Effective DateAugust 14, 2020
FDA Product Classification
INGREDIENTS (12)
OLANZAPINEActive
Quantity: 7.5 mg in 1 1
Code: N7U69T4SZR
Classification: ACTIB
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
Olanzapine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code14445-107
Application NumberANDA206155
Product Classification
M
Marketing Category
C73584
G
Generic Name
Olanzapine
Product Specifications
Route of AdministrationORAL
Effective DateAugust 14, 2020
FDA Product Classification
INGREDIENTS (12)
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
OLANZAPINEActive
Quantity: 5 mg in 1 1
Code: N7U69T4SZR
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT