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Olanzapine

OLANZAPINE tablet, orally disintegrating for oral use Initial U.S. Approval: 1996

Approved
Approval ID

9847a0e4-24fc-f4e8-e053-2995a90a961e

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 27, 2023

Manufacturers
FDA

Golden State Medical Supply, Inc.

DUNS: 603184490

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 Code51407-263
Application NumberANDA091265
Product Classification
M
Marketing Category
C73584
G
Generic Name
Olanzapine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 27, 2023
FDA Product Classification

INGREDIENTS (7)

MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
CARBOXYMETHYLCELLULOSE CALCIUMInactive
Code: UTY7PDF93L
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
OLANZAPINEActive
Quantity: 15 mg in 1 1
Code: N7U69T4SZR
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

Olanzapine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code51407-262
Application NumberANDA091265
Product Classification
M
Marketing Category
C73584
G
Generic Name
Olanzapine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 27, 2023
FDA Product Classification

INGREDIENTS (7)

MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CARBOXYMETHYLCELLULOSE CALCIUMInactive
Code: UTY7PDF93L
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
OLANZAPINEActive
Quantity: 10 mg in 1 1
Code: N7U69T4SZR
Classification: ACTIB

Olanzapine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code51407-264
Application NumberANDA091265
Product Classification
M
Marketing Category
C73584
G
Generic Name
Olanzapine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 27, 2023
FDA Product Classification

INGREDIENTS (7)

MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
CARBOXYMETHYLCELLULOSE CALCIUMInactive
Code: UTY7PDF93L
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
OLANZAPINEActive
Quantity: 20 mg in 1 1
Code: N7U69T4SZR
Classification: ACTIB

Olanzapine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code51407-261
Application NumberANDA091265
Product Classification
M
Marketing Category
C73584
G
Generic Name
Olanzapine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 27, 2023
FDA Product Classification

INGREDIENTS (7)

MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CARBOXYMETHYLCELLULOSE CALCIUMInactive
Code: UTY7PDF93L
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
OLANZAPINEActive
Quantity: 5 mg in 1 1
Code: N7U69T4SZR
Classification: ACTIB

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Olanzapine - FDA Drug Approval Details