NDC Code(s) : 0378-0630-91, 0378-0630-01, 0378-0630-88, 0378-0631-91, 0378-0631-01, 0378-0631-88, 0378-0632-91, 0378-0632-01, 0378-0632-88, 0378-0633-91, 0378-0633-01, 0378-0633-88, 0378-0634-91, 0378-0634-01, 0378-0634-88, 0378-0635-91, 0378-0635-01, 0378-0635-88, 0378-0636-91, 0378-0636-01, 0378-0636-88
Packager : Mylan Pharmaceuticals Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

IloperidoneIloperidone TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-0630
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ILOPERIDONE(UNII: VPO7KJ050N)
(ILOPERIDONE - UNII:VPO7KJ050N) 		ILOPERIDONE1 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE(UNII: 68401960MK)
HYPROMELLOSES(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SODIUM BICARBONATE(UNII: 8MDF5V39QO)
WATER(UNII: 059QF0KO0R)
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 6 mm
Flavor Imprint Code 050
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0378-0630-9160 in 1 BOTTLE Type 0: Not a Combination Product20/03/2017
2NDC:0378-0630-01100 in 1 BOTTLE Type 0: Not a Combination Product20/03/2017
3NDC:0378-0630-8810 in 1 CARTON 20/03/2017
310 in 1 BLISTER PACK Type 0: Not a Combination Product20/03/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207231 03/20/2017
IloperidoneIloperidone TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-0631
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ILOPERIDONE(UNII: VPO7KJ050N)
(ILOPERIDONE - UNII:VPO7KJ050N) 		ILOPERIDONE2 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE(UNII: 68401960MK)
HYPROMELLOSES(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SODIUM BICARBONATE(UNII: 8MDF5V39QO)
WATER(UNII: 059QF0KO0R)
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 7 mm
Flavor Imprint Code 051
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0378-0631-9160 in 1 BOTTLE Type 0: Not a Combination Product20/03/2017
2NDC:0378-0631-01100 in 1 BOTTLE Type 0: Not a Combination Product20/03/2017
3NDC:0378-0631-8810 in 1 CARTON 20/03/2017
310 in 1 BLISTER PACK Type 0: Not a Combination Product20/03/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207231 03/20/2017
IloperidoneIloperidone TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-0632
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ILOPERIDONE(UNII: VPO7KJ050N)
(ILOPERIDONE - UNII:VPO7KJ050N) 		ILOPERIDONE4 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE(UNII: 68401960MK)
HYPROMELLOSES(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SODIUM BICARBONATE(UNII: 8MDF5V39QO)
WATER(UNII: 059QF0KO0R)
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 7 mm
Flavor Imprint Code 052
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0378-0632-9160 in 1 BOTTLE Type 0: Not a Combination Product20/03/2017
2NDC:0378-0632-01100 in 1 BOTTLE Type 0: Not a Combination Product20/03/2017
3NDC:0378-0632-8810 in 1 CARTON 20/03/2017
310 in 1 BLISTER PACK Type 0: Not a Combination Product20/03/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207231 03/20/2017
IloperidoneIloperidone TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-0633
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ILOPERIDONE(UNII: VPO7KJ050N)
(ILOPERIDONE - UNII:VPO7KJ050N) 		ILOPERIDONE6 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE(UNII: 68401960MK)
HYPROMELLOSES(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM SALICYLATE(UNII: 41728CY7UX)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SODIUM BICARBONATE(UNII: 8MDF5V39QO)
WATER(UNII: 059QF0KO0R)
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 7 mm
Flavor Imprint Code 053
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0378-0633-9160 in 1 BOTTLE Type 0: Not a Combination Product20/03/2017
2NDC:0378-0633-01100 in 1 BOTTLE Type 0: Not a Combination Product20/03/2017
3NDC:0378-0633-8810 in 1 CARTON 20/03/2017
310 in 1 BLISTER PACK Type 0: Not a Combination Product20/03/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207231 03/20/2017
IloperidoneIloperidone TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-0634
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ILOPERIDONE(UNII: VPO7KJ050N)
(ILOPERIDONE - UNII:VPO7KJ050N) 		ILOPERIDONE8 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE(UNII: 68401960MK)
HYPROMELLOSES(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SODIUM BICARBONATE(UNII: 8MDF5V39QO)
WATER(UNII: 059QF0KO0R)
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 8 mm
Flavor Imprint Code 054
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0378-0634-9160 in 1 BOTTLE Type 0: Not a Combination Product20/03/2017
2NDC:0378-0634-01100 in 1 BOTTLE Type 0: Not a Combination Product20/03/2017
3NDC:0378-0634-8810 in 1 CARTON 20/03/2017
310 in 1 BLISTER PACK Type 0: Not a Combination Product20/03/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207231 03/20/2017
IloperidoneIloperidone TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-0635
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ILOPERIDONE(UNII: VPO7KJ050N)
(ILOPERIDONE - UNII:VPO7KJ050N) 		ILOPERIDONE10 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE(UNII: 68401960MK)
HYPROMELLOSES(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SODIUM BICARBONATE(UNII: 8MDF5V39QO)
WATER(UNII: 059QF0KO0R)
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 9 mm
Flavor Imprint Code 055
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0378-0635-9160 in 1 BOTTLE Type 0: Not a Combination Product20/03/2017
2NDC:0378-0635-01100 in 1 BOTTLE Type 0: Not a Combination Product20/03/2017
3NDC:0378-0635-8810 in 1 CARTON 20/03/2017
310 in 1 BLISTER PACK Type 0: Not a Combination Product20/03/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207231 03/20/2017
IloperidoneIloperidone TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-0636
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ILOPERIDONE(UNII: VPO7KJ050N)
(ILOPERIDONE - UNII:VPO7KJ050N) 		ILOPERIDONE12 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE(UNII: 68401960MK)
HYPROMELLOSES(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SODIUM BICARBONATE(UNII: 8MDF5V39QO)
WATER(UNII: 059QF0KO0R)
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 10 mm
Flavor Imprint Code 056
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0378-0636-9160 in 1 BOTTLE Type 0: Not a Combination Product20/03/2017
2NDC:0378-0636-01100 in 1 BOTTLE Type 0: Not a Combination Product20/03/2017
3NDC:0378-0636-8810 in 1 CARTON 20/03/2017
310 in 1 BLISTER PACK Type 0: Not a Combination Product20/03/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207231 03/20/2017

LABELER - Mylan Pharmaceuticals Inc.(059295980)

REGISTRANT - Inventia Healthcare Private Limited(650452522)

Establishment
Name Address ID/FEI Business Operations
Inventia healthcare Limited 677604412 ANALYSIS(0378-0630, 0378-0631, 0378-0632, 0378-0633, 0378-0634, 0378-0635, 0378-0636), MANUFACTURE(0378-0630, 0378-0631, 0378-0632, 0378-0633, 0378-0634, 0378-0635, 0378-0636)

PRINCIPAL DISPLAY PANEL

Iloperidone Tablets 1 mg Label 60 counts

9e1900e4-eae1-4295-826c-d598e3486e5a-02

PRINCIPAL DISPLAY PANEL

Iloperidone Tablets 2  mg Label 60 counts

9e1900e4-eae1-4295-826c-d598e3486e5a-03

PRINCIPAL DISPLAY PANEL

Iloperidone Tablets 4 mg Label 60 counts

9e1900e4-eae1-4295-826c-d598e3486e5a-04

PRINCIPAL DISPLAY PANEL

Iloperidone Tablets 6 mg Label 60 counts

9e1900e4-eae1-4295-826c-d598e3486e5a-05

PRINCIPAL DISPLAY PANEL

Iloperidone Tablets 8 mg Label 60 counts

9e1900e4-eae1-4295-826c-d598e3486e5a-06

PRINCIPAL DISPLAY PANEL

Iloperidone Tablets  10  mg Label 60 counts

9e1900e4-eae1-4295-826c-d598e3486e5a-07

PRINCIPAL DISPLAY PANEL

Iloperidone Tablets  12  mg Label 60 counts

9e1900e4-eae1-4295-826c-d598e3486e5a-08