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
9db7aefb-f607-4158-a310-181e631bc648
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 4, 2024
Manufacturers
FDA
Major Pharmaceuticals
DUNS: 191427277
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
CLOZAPINE
PRODUCT DETAILS
NDC Product Code0904-7406
Application NumberANDA206433
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 4, 2024
Generic NameCLOZAPINE
INGREDIENTS (7)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CLOZAPINEActive
Quantity: 50 mg in 1 1
Code: J60AR2IKIC
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
CLOZAPINE
PRODUCT DETAILS
NDC Product Code0904-7089
Application NumberANDA206433
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 4, 2024
Generic NameCLOZAPINE
INGREDIENTS (7)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
CLOZAPINEActive
Quantity: 25 mg in 1 1
Code: J60AR2IKIC
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
CLOZAPINE
PRODUCT DETAILS
NDC Product Code0904-7087
Application NumberANDA206433
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 4, 2024
Generic NameCLOZAPINE
INGREDIENTS (7)
CLOZAPINEActive
Quantity: 100 mg in 1 1
Code: J60AR2IKIC
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CLOZAPINE
PRODUCT DETAILS
NDC Product Code0904-7088
Application NumberANDA206433
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 4, 2024
Generic NameCLOZAPINE
INGREDIENTS (7)
CLOZAPINEActive
Quantity: 200 mg in 1 1
Code: J60AR2IKIC
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT