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 useInitial U.S. Approval: 2009
Approved
Approval ID
6f17cc91-86b3-42e3-9bf2-935dd360c3eb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 2, 2019
Manufacturers
FDA
Taro Pharmaceuticals U.S.A., Inc.
DUNS: 145186370
Products 8
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 Code51672-4184
Application NumberANDA207098
Product Classification
M
Marketing Category
C73584
G
Generic Name
Iloperidone
Product Specifications
Route of AdministrationORAL
Effective DateMarch 29, 2018
FDA Product Classification
INGREDIENTS (8)
microcrystalline celluloseInactive
Code: OP1R32D61U
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
IloperidoneActive
Quantity: 12 mg in 1 1
Code: VPO7KJ050N
Classification: ACTIB
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
hypromellose, unspecifiedInactive
Code: 3NXW29V3WO
Classification: IACT
crospovidone (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
Iloperidone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51672-4182
Application NumberANDA207098
Product Classification
M
Marketing Category
C73584
G
Generic Name
Iloperidone
Product Specifications
Route of AdministrationORAL
Effective DateMarch 29, 2018
FDA Product Classification
INGREDIENTS (8)
hypromellose, unspecifiedInactive
Code: 3NXW29V3WO
Classification: IACT
IloperidoneActive
Quantity: 8 mg in 1 1
Code: VPO7KJ050N
Classification: ACTIB
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
crospovidone (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
microcrystalline celluloseInactive
Code: OP1R32D61U
Classification: IACT
Iloperidone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51672-4183
Application NumberANDA207098
Product Classification
M
Marketing Category
C73584
G
Generic Name
Iloperidone
Product Specifications
Route of AdministrationORAL
Effective DateMarch 29, 2018
FDA Product Classification
INGREDIENTS (8)
crospovidone (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
hypromellose, unspecifiedInactive
Code: 3NXW29V3WO
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
IloperidoneActive
Quantity: 10 mg in 1 1
Code: VPO7KJ050N
Classification: ACTIB
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
microcrystalline celluloseInactive
Code: OP1R32D61U
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
Iloperidone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51672-4181
Application NumberANDA207098
Product Classification
M
Marketing Category
C73584
G
Generic Name
Iloperidone
Product Specifications
Route of AdministrationORAL
Effective DateMarch 29, 2018
FDA Product Classification
INGREDIENTS (8)
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
IloperidoneActive
Quantity: 6 mg in 1 1
Code: VPO7KJ050N
Classification: ACTIB
crospovidone (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
hypromellose, unspecifiedInactive
Code: 3NXW29V3WO
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
microcrystalline celluloseInactive
Code: OP1R32D61U
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
Iloperidone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51672-4180
Application NumberANDA207098
Product Classification
M
Marketing Category
C73584
G
Generic Name
Iloperidone
Product Specifications
Route of AdministrationORAL
Effective DateMarch 29, 2018
FDA Product Classification
INGREDIENTS (8)
IloperidoneActive
Quantity: 4 mg in 1 1
Code: VPO7KJ050N
Classification: ACTIB
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
crospovidone (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
hypromellose, unspecifiedInactive
Code: 3NXW29V3WO
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
microcrystalline celluloseInactive
Code: OP1R32D61U
Classification: IACT
Iloperidone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51672-4178
Application NumberANDA207098
Product Classification
M
Marketing Category
C73584
G
Generic Name
Iloperidone
Product Specifications
Route of AdministrationORAL
Effective DateMarch 29, 2018
FDA Product Classification
INGREDIENTS (8)
IloperidoneActive
Quantity: 1 mg in 1 1
Code: VPO7KJ050N
Classification: ACTIB
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
crospovidone (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
hypromellose, unspecifiedInactive
Code: 3NXW29V3WO
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
microcrystalline celluloseInactive
Code: OP1R32D61U
Classification: IACT
Iloperidone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51672-4179
Application NumberANDA207098
Product Classification
M
Marketing Category
C73584
G
Generic Name
Iloperidone
Product Specifications
Route of AdministrationORAL
Effective DateMarch 29, 2018
FDA Product Classification
INGREDIENTS (8)
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
hypromellose, unspecifiedInactive
Code: 3NXW29V3WO
Classification: IACT
IloperidoneActive
Quantity: 2 mg in 1 1
Code: VPO7KJ050N
Classification: ACTIB
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
crospovidone (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
microcrystalline celluloseInactive
Code: OP1R32D61U
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
Iloperidone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51672-4213
Application NumberANDA207098
Product Classification
M
Marketing Category
C73584
G
Generic Name
Iloperidone
Product Specifications
Effective DateMarch 29, 2018
FDA Product Classification