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
f0943b4e-6bdc-48c1-8ecd-39cf732e16f5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 4, 2023
Manufacturers
FDA
Modavar Pharmaceuticals LLC
DUNS: 858949204
Products 6
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Olanzapine
PRODUCT DETAILS
NDC Product Code72241-051
Application NumberANDA210022
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 19, 2023
Generic NameOlanzapine
INGREDIENTS (9)
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
OLANZAPINEActive
Quantity: 2.5 mg in 1 1
Code: N7U69T4SZR
Classification: ACTIB
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
Olanzapine
PRODUCT DETAILS
NDC Product Code72241-052
Application NumberANDA210022
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 19, 2023
Generic NameOlanzapine
INGREDIENTS (9)
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
OLANZAPINEActive
Quantity: 5 mg in 1 1
Code: N7U69T4SZR
Classification: ACTIB
Olanzapine
PRODUCT DETAILS
NDC Product Code72241-056
Application NumberANDA210022
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 19, 2023
Generic NameOlanzapine
INGREDIENTS (9)
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
OLANZAPINEActive
Quantity: 20 mg in 1 1
Code: N7U69T4SZR
Classification: ACTIB
Olanzapine
PRODUCT DETAILS
NDC Product Code72241-054
Application NumberANDA210022
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 19, 2023
Generic NameOlanzapine
INGREDIENTS (9)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
OLANZAPINEActive
Quantity: 10 mg in 1 1
Code: N7U69T4SZR
Classification: ACTIB
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
Olanzapine
PRODUCT DETAILS
NDC Product Code72241-055
Application NumberANDA210022
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 19, 2023
Generic NameOlanzapine
INGREDIENTS (9)
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
OLANZAPINEActive
Quantity: 15 mg in 1 1
Code: N7U69T4SZR
Classification: ACTIB
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
Olanzapine
PRODUCT DETAILS
NDC Product Code72241-053
Application NumberANDA210022
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 19, 2023
Generic NameOlanzapine
INGREDIENTS (9)
OLANZAPINEActive
Quantity: 7.5 mg in 1 1
Code: N7U69T4SZR
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT