Clozapine
These highlights do not include all the information needed to use CLOZAPINE TABLETS safely and effectively. See full prescribing information for CLOZAPINE TABLETS. CLOZAPINE tablets, for oral use Initial U.S. Approval: 1989
Approved
Approval ID
d5c8a456-6f3c-4963-b321-4ed746f690e4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 27, 2023
Manufacturers
FDA
Mylan Institutional Inc.
DUNS: 039615992
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
clozapine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51079-921
Application NumberANDA075417
Product Classification
M
Marketing Category
C73584
G
Generic Name
clozapine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 27, 2023
FDA Product Classification
INGREDIENTS (8)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
CLOZAPINEActive
Quantity: 25 mg in 1 1
Code: J60AR2IKIC
Classification: ACTIB
clozapine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51079-749
Application NumberANDA075417
Product Classification
M
Marketing Category
C73584
G
Generic Name
clozapine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 27, 2023
FDA Product Classification
INGREDIENTS (8)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
CLOZAPINEActive
Quantity: 200 mg in 1 1
Code: J60AR2IKIC
Classification: ACTIB
clozapine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51079-922
Application NumberANDA075417
Product Classification
M
Marketing Category
C73584
G
Generic Name
clozapine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 27, 2023
FDA Product Classification
INGREDIENTS (8)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
CLOZAPINEActive
Quantity: 100 mg in 1 1
Code: J60AR2IKIC
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT