Iloperidone
These highlights do not include all the information needed to use ILOPERIDONE TABLETS safely and effectively. See full prescribing information for ILOPERIDONE TABLETS. ILOPERIDONE tablets, for oral use Initial U.S. Approval: 2009
Approved
Approval ID
eeb0fcfd-e4e8-4fb1-9635-901dc9446235
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 21, 2022
Manufacturers
FDA
Mylan Pharmaceuticals Inc.
DUNS: 059295980
Products 7
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Iloperidone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-0632
Application NumberANDA207231
Product Classification
M
Marketing Category
C73584
G
Generic Name
Iloperidone
Product Specifications
Route of AdministrationORAL
Effective DateDecember 21, 2022
FDA Product Classification
INGREDIENTS (9)
ILOPERIDONEActive
Quantity: 4 mg in 1 1
Code: VPO7KJ050N
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Iloperidone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-0633
Application NumberANDA207231
Product Classification
M
Marketing Category
C73584
G
Generic Name
Iloperidone
Product Specifications
Route of AdministrationORAL
Effective DateDecember 21, 2022
FDA Product Classification
INGREDIENTS (9)
ILOPERIDONEActive
Quantity: 6 mg in 1 1
Code: VPO7KJ050N
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM SALICYLATEInactive
Code: 41728CY7UX
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
Iloperidone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-0635
Application NumberANDA207231
Product Classification
M
Marketing Category
C73584
G
Generic Name
Iloperidone
Product Specifications
Route of AdministrationORAL
Effective DateDecember 21, 2022
FDA Product Classification
INGREDIENTS (9)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ILOPERIDONEActive
Quantity: 10 mg in 1 1
Code: VPO7KJ050N
Classification: ACTIB
Iloperidone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-0634
Application NumberANDA207231
Product Classification
M
Marketing Category
C73584
G
Generic Name
Iloperidone
Product Specifications
Route of AdministrationORAL
Effective DateDecember 21, 2022
FDA Product Classification
INGREDIENTS (9)
ILOPERIDONEActive
Quantity: 8 mg in 1 1
Code: VPO7KJ050N
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
Iloperidone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-0630
Application NumberANDA207231
Product Classification
M
Marketing Category
C73584
G
Generic Name
Iloperidone
Product Specifications
Route of AdministrationORAL
Effective DateDecember 21, 2022
FDA Product Classification
INGREDIENTS (9)
ILOPERIDONEActive
Quantity: 1 mg in 1 1
Code: VPO7KJ050N
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Iloperidone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-0631
Application NumberANDA207231
Product Classification
M
Marketing Category
C73584
G
Generic Name
Iloperidone
Product Specifications
Route of AdministrationORAL
Effective DateDecember 21, 2022
FDA Product Classification
INGREDIENTS (9)
ILOPERIDONEActive
Quantity: 2 mg in 1 1
Code: VPO7KJ050N
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
Iloperidone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-0636
Application NumberANDA207231
Product Classification
M
Marketing Category
C73584
G
Generic Name
Iloperidone
Product Specifications
Route of AdministrationORAL
Effective DateDecember 21, 2022
FDA Product Classification
INGREDIENTS (8)
ILOPERIDONEActive
Quantity: 12 mg in 1 1
Code: VPO7KJ050N
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT