Olanzapine
These highlights do not include all the information needed to use OLANZAPINE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for OLANZAPINE ORALLY DISINTEGRATING TABLETS. OLANZAPINE orally disintegrating tablets for Oral use Initial U.S. Approval: 1996
Approved
Approval ID
028aa88e-fa50-7aa8-cc0b-97c0c9a0357c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 27, 2025
Manufacturers
FDA
Jubilant Cadista Pharmacuticals Inc.
DUNS: 118694141
Products 4
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 Code59746-306
Application NumberANDA200221
Product Classification
M
Marketing Category
C73584
G
Generic Name
Olanzapine
Product Specifications
Route of AdministrationORAL
Effective DateMarch 27, 2025
FDA Product Classification
INGREDIENTS (11)
OlanzapineActive
Quantity: 5 mg in 1 1
Code: N7U69T4SZR
Classification: ACTIB
Hydroxypropyl Cellulose, Low SubstitutedInactive
Code: 2165RE0K14
Classification: IACT
MannitolInactive
Code: 3OWL53L36A
Classification: IACT
Cellulose, MicrocrystallineInactive
Code: OP1R32D61U
Classification: IACT
AspartameInactive
Code: Z0H242BBR1
Classification: IACT
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
MaltodextrinInactive
Code: 7CVR7L4A2D
Classification: IACT
Benzyl AlcoholInactive
Code: LKG8494WBH
Classification: IACT
Propylene GlycolInactive
Code: 6DC9Q167V3
Classification: IACT
Triethyl CitrateInactive
Code: 8Z96QXD6UM
Classification: IACT
Olanzapine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59746-309
Application NumberANDA200221
Product Classification
M
Marketing Category
C73584
G
Generic Name
Olanzapine
Product Specifications
Route of AdministrationORAL
Effective DateMarch 27, 2025
FDA Product Classification
INGREDIENTS (11)
OlanzapineActive
Quantity: 20 mg in 1 1
Code: N7U69T4SZR
Classification: ACTIB
Hydroxypropyl Cellulose, Low SubstitutedInactive
Code: 2165RE0K14
Classification: IACT
MannitolInactive
Code: 3OWL53L36A
Classification: IACT
Cellulose, MicrocrystallineInactive
Code: OP1R32D61U
Classification: IACT
AspartameInactive
Code: Z0H242BBR1
Classification: IACT
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
MaltodextrinInactive
Code: 7CVR7L4A2D
Classification: IACT
Triethyl CitrateInactive
Code: 8Z96QXD6UM
Classification: IACT
Benzyl AlcoholInactive
Code: LKG8494WBH
Classification: IACT
Propylene GlycolInactive
Code: 6DC9Q167V3
Classification: IACT
Olanzapine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59746-307
Application NumberANDA200221
Product Classification
M
Marketing Category
C73584
G
Generic Name
Olanzapine
Product Specifications
Route of AdministrationORAL
Effective DateMarch 27, 2025
FDA Product Classification
INGREDIENTS (11)
OlanzapineActive
Quantity: 10 mg in 1 1
Code: N7U69T4SZR
Classification: ACTIB
Hydroxypropyl Cellulose, Low SubstitutedInactive
Code: 2165RE0K14
Classification: IACT
Triethyl CitrateInactive
Code: 8Z96QXD6UM
Classification: IACT
Benzyl AlcoholInactive
Code: LKG8494WBH
Classification: IACT
Propylene GlycolInactive
Code: 6DC9Q167V3
Classification: IACT
MannitolInactive
Code: 3OWL53L36A
Classification: IACT
Cellulose, MicrocrystallineInactive
Code: OP1R32D61U
Classification: IACT
AspartameInactive
Code: Z0H242BBR1
Classification: IACT
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
MaltodextrinInactive
Code: 7CVR7L4A2D
Classification: IACT
Olanzapine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59746-308
Application NumberANDA200221
Product Classification
M
Marketing Category
C73584
G
Generic Name
Olanzapine
Product Specifications
Route of AdministrationORAL
Effective DateMarch 27, 2025
FDA Product Classification
INGREDIENTS (11)
Cellulose, MicrocrystallineInactive
Code: OP1R32D61U
Classification: IACT
AspartameInactive
Code: Z0H242BBR1
Classification: IACT
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
MaltodextrinInactive
Code: 7CVR7L4A2D
Classification: IACT
Triethyl CitrateInactive
Code: 8Z96QXD6UM
Classification: IACT
Benzyl AlcoholInactive
Code: LKG8494WBH
Classification: IACT
Propylene GlycolInactive
Code: 6DC9Q167V3
Classification: IACT
OlanzapineActive
Quantity: 15 mg in 1 1
Code: N7U69T4SZR
Classification: ACTIB
Hydroxypropyl Cellulose, Low SubstitutedInactive
Code: 2165RE0K14
Classification: IACT
MannitolInactive
Code: 3OWL53L36A
Classification: IACT