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
3347d1c8-04c9-5ce1-8cda-b38e0412b709
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 19, 2023
Manufacturers
FDA
Apotex Corp.
DUNS: 845263701
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 Code60505-3113
Application NumberANDA090798
Product Classification
M
Marketing Category
C73584
G
Generic Name
Olanzapine
Product Specifications
Route of AdministrationORAL
Effective DateJuly 19, 2023
FDA Product Classification
INGREDIENTS (9)
OlanzapineActive
Quantity: 10 mg in 1 1
Code: N7U69T4SZR
Classification: ACTIB
Cellulose, MicrocrystallineInactive
Code: OP1R32D61U
Classification: IACT
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
Starch, CornInactive
Code: O8232NY3SJ
Classification: IACT
Hypromellose 2910 (6 Mpa.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
Polyethylene Glycol 1000Inactive
Code: U076Q6Q621
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Olanzapine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60505-3140
Application NumberANDA090798
Product Classification
M
Marketing Category
C73584
G
Generic Name
Olanzapine
Product Specifications
Route of AdministrationORAL
Effective DateJuly 19, 2023
FDA Product Classification
INGREDIENTS (11)
OlanzapineActive
Quantity: 20 mg in 1 1
Code: N7U69T4SZR
Classification: ACTIB
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
Cellulose, MicrocrystallineInactive
Code: OP1R32D61U
Classification: IACT
Starch, CornInactive
Code: O8232NY3SJ
Classification: IACT
Hypromellose 2910 (6 Mpa.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Ferric Oxide RedInactive
Code: 1K09F3G675
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
Ferric Oxide YellowInactive
Code: EX438O2MRT
Classification: IACT
Polyethylene Glycol 1000Inactive
Code: U076Q6Q621
Classification: IACT
Olanzapine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60505-3112
Application NumberANDA090798
Product Classification
M
Marketing Category
C73584
G
Generic Name
Olanzapine
Product Specifications
Route of AdministrationORAL
Effective DateJuly 19, 2023
FDA Product Classification
INGREDIENTS (9)
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
OlanzapineActive
Quantity: 7.5 mg in 1 1
Code: N7U69T4SZR
Classification: ACTIB
Cellulose, MicrocrystallineInactive
Code: OP1R32D61U
Classification: IACT
Hypromellose 2910 (6 Mpa.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
Starch, CornInactive
Code: O8232NY3SJ
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
Polyethylene Glycol 1000Inactive
Code: U076Q6Q621
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Olanzapine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60505-3114
Application NumberANDA090798
Product Classification
M
Marketing Category
C73584
G
Generic Name
Olanzapine
Product Specifications
Route of AdministrationORAL
Effective DateJuly 19, 2023
FDA Product Classification
INGREDIENTS (10)
OlanzapineActive
Quantity: 15 mg in 1 1
Code: N7U69T4SZR
Classification: ACTIB
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
Starch, CornInactive
Code: O8232NY3SJ
Classification: IACT
Cellulose, MicrocrystallineInactive
Code: OP1R32D61U
Classification: IACT
Hypromellose 2910 (6 Mpa.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
Polyethylene Glycol 1000Inactive
Code: U076Q6Q621
Classification: IACT
Fd&C Blue No. 2Inactive
Code: L06K8R7DQK
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Olanzapine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60505-3111
Application NumberANDA090798
Product Classification
M
Marketing Category
C73584
G
Generic Name
Olanzapine
Product Specifications
Route of AdministrationORAL
Effective DateJuly 19, 2023
FDA Product Classification
INGREDIENTS (9)
Cellulose, MicrocrystallineInactive
Code: OP1R32D61U
Classification: IACT
OlanzapineActive
Quantity: 5 mg in 1 1
Code: N7U69T4SZR
Classification: ACTIB
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
Starch, CornInactive
Code: O8232NY3SJ
Classification: IACT
Hypromellose 2910 (6 Mpa.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
Polyethylene Glycol 1000Inactive
Code: U076Q6Q621
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Olanzapine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60505-3110
Application NumberANDA090798
Product Classification
M
Marketing Category
C73584
G
Generic Name
Olanzapine
Product Specifications
Route of AdministrationORAL
Effective DateJuly 19, 2023
FDA Product Classification
INGREDIENTS (9)
OlanzapineActive
Quantity: 2.5 mg in 1 1
Code: N7U69T4SZR
Classification: ACTIB
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
Hypromellose 2910 (6 Mpa.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
Starch, CornInactive
Code: O8232NY3SJ
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Cellulose, MicrocrystallineInactive
Code: OP1R32D61U
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
Polyethylene Glycol 1000Inactive
Code: U076Q6Q621
Classification: IACT