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
75616c31-8fed-4014-a9f2-4a028eccd586
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 4, 2022
Manufacturers
FDA
American Health Packaging
DUNS: 929561009
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 Code68084-740
Application NumberANDA076255
Product Classification
M
Marketing Category
C73584
G
Generic Name
Olanzapine
Product Specifications
Route of AdministrationORAL
Effective DateOctober 4, 2022
FDA Product Classification
INGREDIENTS (9)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
OLANZAPINEActive
Quantity: 10 mg in 1 1
Code: N7U69T4SZR
Classification: ACTIB
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
Olanzapine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68084-525
Application NumberANDA076255
Product Classification
M
Marketing Category
C73584
G
Generic Name
Olanzapine
Product Specifications
Route of AdministrationORAL
Effective DateOctober 4, 2022
FDA Product Classification
INGREDIENTS (9)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
OLANZAPINEActive
Quantity: 2.5 mg in 1 1
Code: N7U69T4SZR
Classification: ACTIB
Olanzapine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68084-723
Application NumberANDA076255
Product Classification
M
Marketing Category
C73584
G
Generic Name
Olanzapine
Product Specifications
Route of AdministrationORAL
Effective DateOctober 4, 2022
FDA Product Classification
INGREDIENTS (9)
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
OLANZAPINEActive
Quantity: 5 mg in 1 1
Code: N7U69T4SZR
Classification: ACTIB