Iloperidone (Page 8 of 8)

PRINCIPAL DISPLAY PANEL — 6 mg Tablet Bottle Label

NDC 51672-4181-4

60 Tablets

Iloperidone Tablets 6 mg

Keep this and all medications out of the reach of children.

TARO

Rx only

PRINCIPAL DISPLAY PANEL -- 6 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 8 mg Tablet Bottle Label

NDC 51672-4182-4

60 Tablets

Iloperidone Tablets 8 mg

Keep this and all medications out of the reach of children.

TARO

Rx only

PRINCIPAL DISPLAY PANEL -- 8 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 10 mg Tablet Bottle Label

NDC 51672-4183-4

60 Tablets

Iloperidone Tablets 10 mg

Keep this and all medications out of the reach of children.

TARO

Rx only

PRINCIPAL DISPLAY PANEL -- 10 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 12 mg Tablet Bottle Label

NDC 51672-4184-4

60 Tablets

Iloperidone Tablets 12 mg

Keep this and all medications out of the reach of children.

TARO

Rx only

PRINCIPAL DISPLAY PANEL -- 12 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — Kit Titration Pack

51672-4213-7

Iloperidone Tablets

TITRATION PACK

This pack contains:

Two 1-mg tablets
Two 2-mg tablets
Two 4-mg tablets
Two 6-mg tablets

Store at 20° to 25°C (68° to 77°F)
[see USP Controlled RoomTemperature].

Protect from light and moisture.

Keep out of reach of children.

TARO

8 TABLETS

Rx only

PRINCIPAL DISPLAY PANEL -- Kit Titration Pack
(click image for full-size original)
ILOPERIDONE iloperidone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51672-4178
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Iloperidone (Iloperidone) Iloperidone 1 mg
Inactive Ingredients
Ingredient Name Strength
silicon dioxide
crospovidone (15 MPA.S AT 5%)
hypromellose, unspecified
lactose monohydrate
magnesium stearate
microcrystalline cellulose
water
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 6mm
Flavor Imprint Code T;1
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51672-4178-4 60 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207098 07/22/2019
ILOPERIDONE iloperidone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51672-4179
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Iloperidone (Iloperidone) Iloperidone 2 mg
Inactive Ingredients
Ingredient Name Strength
silicon dioxide
crospovidone (15 MPA.S AT 5%)
hypromellose, unspecified
lactose monohydrate
magnesium stearate
microcrystalline cellulose
water
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 6mm
Flavor Imprint Code T;2
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51672-4179-4 60 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207098 07/22/2019
ILOPERIDONE iloperidone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51672-4180
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Iloperidone (Iloperidone) Iloperidone 4 mg
Inactive Ingredients
Ingredient Name Strength
silicon dioxide
crospovidone (15 MPA.S AT 5%)
hypromellose, unspecified
lactose monohydrate
magnesium stearate
microcrystalline cellulose
water
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 8mm
Flavor Imprint Code T;4
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51672-4180-4 60 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207098 07/22/2019
ILOPERIDONE iloperidone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51672-4181
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Iloperidone (Iloperidone) Iloperidone 6 mg
Inactive Ingredients
Ingredient Name Strength
silicon dioxide
crospovidone (15 MPA.S AT 5%)
hypromellose, unspecified
lactose monohydrate
magnesium stearate
microcrystalline cellulose
water
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 9mm
Flavor Imprint Code T;6
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51672-4181-4 60 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207098 07/22/2019
ILOPERIDONE iloperidone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51672-4182
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Iloperidone (Iloperidone) Iloperidone 8 mg
Inactive Ingredients
Ingredient Name Strength
silicon dioxide
crospovidone (15 MPA.S AT 5%)
hypromellose, unspecified
lactose monohydrate
magnesium stearate
microcrystalline cellulose
water
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 10mm
Flavor Imprint Code T;8
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51672-4182-4 60 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207098 07/22/2019
ILOPERIDONE iloperidone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51672-4183
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Iloperidone (Iloperidone) Iloperidone 10 mg
Inactive Ingredients
Ingredient Name Strength
silicon dioxide
crospovidone (15 MPA.S AT 5%)
hypromellose, unspecified
lactose monohydrate
magnesium stearate
microcrystalline cellulose
water
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 11mm
Flavor Imprint Code T;10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51672-4183-4 60 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207098 07/22/2019
ILOPERIDONE iloperidone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51672-4184
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Iloperidone (Iloperidone) Iloperidone 12 mg
Inactive Ingredients
Ingredient Name Strength
silicon dioxide
crospovidone (15 MPA.S AT 5%)
hypromellose, unspecified
lactose monohydrate
magnesium stearate
microcrystalline cellulose
water
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 12mm
Flavor Imprint Code T;12
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51672-4184-4 60 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207098 07/22/2019
ILOPERIDONE iloperidone kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51672-4213
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51672-4213-7 1 BLISTER PACK in 1 DOSE PACK contains a BLISTER PACK
1 1 KIT in 1 BLISTER PACK This package is contained within the DOSE PACK (51672-4213-7)
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 2
Part 2 2
Part 3 2
Part 4 2
Part 1 of 4
ILOPERIDONE iloperidone tablet
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Iloperidone (Iloperidone) Iloperidone 1 mg
Inactive Ingredients
Ingredient Name Strength
silicon dioxide
crospovidone (15 MPA.S AT 5%)
hypromellose, unspecified
lactose monohydrate
magnesium stearate
microcrystalline cellulose
water
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 6mm
Flavor Imprint Code T;1
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207098 07/22/2019
Part 2 of 4
ILOPERIDONE iloperidone tablet
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Iloperidone (Iloperidone) Iloperidone 2 mg
Inactive Ingredients
Ingredient Name Strength
silicon dioxide
crospovidone (15 MPA.S AT 5%)
hypromellose, unspecified
lactose monohydrate
magnesium stearate
microcrystalline cellulose
water
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 6mm
Flavor Imprint Code T;2
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207098 07/22/2019
Part 3 of 4
ILOPERIDONE iloperidone tablet
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Iloperidone (Iloperidone) Iloperidone 4 mg
Inactive Ingredients
Ingredient Name Strength
silicon dioxide
crospovidone (15 MPA.S AT 5%)
hypromellose, unspecified
lactose monohydrate
magnesium stearate
microcrystalline cellulose
water
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 8mm
Flavor Imprint Code T;4
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207098 07/22/2019
Part 4 of 4
ILOPERIDONE iloperidone tablet
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Iloperidone (Iloperidone) Iloperidone 6 mg
Inactive Ingredients
Ingredient Name Strength
silicon dioxide
crospovidone (15 MPA.S AT 5%)
hypromellose, unspecified
lactose monohydrate
magnesium stearate
microcrystalline cellulose
water
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 9mm
Flavor Imprint Code T;6
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207098 07/22/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207098 07/22/2019
Labeler — Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
Name Address ID/FEI Operations
Taro Pharmaceutical Industries Ltd. 600072078 MANUFACTURE (51672-4178), MANUFACTURE (51672-4179), MANUFACTURE (51672-4180), MANUFACTURE (51672-4181), MANUFACTURE (51672-4182), MANUFACTURE (51672-4183), MANUFACTURE (51672-4184), MANUFACTURE (51672-4213)

Revised: 08/2019 Taro Pharmaceuticals U.S.A., Inc.

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