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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

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