ARIPIPRAZOLE - aripiprazole tablet, orally disintegrating
Cadila Healthcare Limited

----------

ARIPIPRAZOLE ORALLY DISINTEGRATING TABLETS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1432-9

Aripiprazole Orally Disintegrating Tablets, 10 mg

90 tablets

Rx only

NDC 70771-1433-9

Aripiprazole Orally Disintegrating Tablets, 15 mg

90 tablets

Rx only

NDC 70771-1434-9

Aripiprazole Orally Disintegrating Tablets, 20 mg

90 tablets

Rx only

NDC 70771-1435-9

Aripiprazole Orally Disintegrating Tablets, 30 mg

90 tablets

Rx only

ARIPIPRAZOLE
aripiprazole tablet, orally disintegrating

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1432
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ARIPIPRAZOLE (UNII: 82VFR53I78) (ARIPIPRAZOLE - UNII:82VFR53I78)	ARIPIPRAZOLE	10 mg

Ingredient Name	Strength
Inactive Ingredients
ASPARTAME (UNII: Z0H242BBR1)
CALCIUM STEARATE (UNII: 776XM7047L)
MANNITOL (UNII: 3OWL53L36A)
PEPPERMINT (UNII: V95R5KMY2B)
CROSPOVIDONE (UNII: 2S7830E561)

Product Characteristics
Color	WHITE (WHITE TO OFF-WHITE)	Score	no score
Shape	CAPSULE (CAPSULE)	Size	8mm
Flavor	PEPPERMINT (FLAVOR FIRMENICH POWDER PEPPERMINT)	Imprint Code	ZF;41
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70771-1432-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	02/06/2019	12/30/2021
2	NDC:70771-1432-6	60 in 1 BOTTLE; Type 0: Not a Combination Product	02/06/2019	12/30/2021
3	NDC:70771-1432-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	02/06/2019	12/30/2021
4	NDC:70771-1432-1	120 in 1 BOTTLE; Type 0: Not a Combination Product	02/06/2019	12/30/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA090165	02/06/2019	12/30/2021

ARIPIPRAZOLE
aripiprazole tablet, orally disintegrating

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1433
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ARIPIPRAZOLE (UNII: 82VFR53I78) (ARIPIPRAZOLE - UNII:82VFR53I78)	ARIPIPRAZOLE	15 mg

Ingredient Name	Strength
Inactive Ingredients
ASPARTAME (UNII: Z0H242BBR1)
CALCIUM STEARATE (UNII: 776XM7047L)
CROSPOVIDONE (UNII: 2S7830E561)
MANNITOL (UNII: 3OWL53L36A)
PEPPERMINT (UNII: V95R5KMY2B)

Product Characteristics
Color	WHITE (WHITE TO OFF-WHITE)	Score	no score
Shape	ROUND (ROUND)	Size	8mm
Flavor	PEPPERMINT (FLAVOR FIRMENICH POWDER PEPPERMINT)	Imprint Code	ZF;42
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70771-1433-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	02/06/2019	12/30/2021
2	NDC:70771-1433-6	60 in 1 BOTTLE; Type 0: Not a Combination Product	02/06/2019	12/30/2021
3	NDC:70771-1433-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	02/06/2019	12/30/2021
4	NDC:70771-1433-1	120 in 1 BOTTLE; Type 0: Not a Combination Product	02/06/2019	12/30/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA090165	02/06/2019	12/30/2021

ARIPIPRAZOLE
aripiprazole tablet, orally disintegrating

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1434
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ARIPIPRAZOLE (UNII: 82VFR53I78) (ARIPIPRAZOLE - UNII:82VFR53I78)	ARIPIPRAZOLE	20 mg

Ingredient Name	Strength
Inactive Ingredients
ASPARTAME (UNII: Z0H242BBR1)
CALCIUM STEARATE (UNII: 776XM7047L)
CROSPOVIDONE (UNII: 2S7830E561)
MANNITOL (UNII: 3OWL53L36A)
PEPPERMINT (UNII: V95R5KMY2B)

Product Characteristics
Color	WHITE (WHITE TO OFF-WHITE)	Score	no score
Shape	OCTAGON (8 SIDED) (BARREL)	Size	8mm
Flavor	PEPPERMINT (FLAVOR FIRMENICH POWDER PEPPERMINT)	Imprint Code	ZF;43
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70771-1434-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	02/06/2019	12/30/2021
2	NDC:70771-1434-6	60 in 1 BOTTLE; Type 0: Not a Combination Product	02/06/2019	12/30/2021
3	NDC:70771-1434-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	02/06/2019	12/30/2021
4	NDC:70771-1434-1	120 in 1 BOTTLE; Type 0: Not a Combination Product	02/06/2019	12/30/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA090165	02/06/2019	12/30/2021

ARIPIPRAZOLE
aripiprazole tablet, orally disintegrating

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1435
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ARIPIPRAZOLE (UNII: 82VFR53I78) (ARIPIPRAZOLE - UNII:82VFR53I78)	ARIPIPRAZOLE	30 mg

Ingredient Name	Strength
Inactive Ingredients
ASPARTAME (UNII: Z0H242BBR1)
CALCIUM STEARATE (UNII: 776XM7047L)
CROSPOVIDONE (UNII: 2S7830E561)
MANNITOL (UNII: 3OWL53L36A)
PEPPERMINT (UNII: V95R5KMY2B)

Product Characteristics
Color	WHITE (WHITE TO OFF-WHITE)	Score	no score
Shape	ROUND (ROUND)	Size	10mm
Flavor	PEPPERMINT (FLAVOR FIRMENICH POWDER PEPPERMINT)	Imprint Code	ZF;44
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70771-1435-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	02/06/2019	12/30/2021
2	NDC:70771-1435-6	60 in 1 BOTTLE; Type 0: Not a Combination Product	02/06/2019	12/30/2021
3	NDC:70771-1435-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	02/06/2019	12/30/2021
4	NDC:70771-1435-1	120 in 1 BOTTLE; Type 0: Not a Combination Product	02/06/2019	12/30/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA090165	02/06/2019	12/30/2021

Labeler - Cadila Healthcare Limited (918596198)

Registrant - Cadila Healthcare Limited (918596198)

Name	Address	ID/FEI	Business Operations
Establishment
Cadila Healthcare Limited		918596198	ANALYSIS(70771-1432, 70771-1433, 70771-1434, 70771-1435) , MANUFACTURE(70771-1432, 70771-1433, 70771-1434, 70771-1435)

Revised: 12/2021

Document Id: 87917ed0-9aa4-444a-b3bf-6fb4a829d268

Set id: 34d09d2e-5780-48bd-a6ea-046108ba84be

Version: 5

Effective Time: 20211230

Cadila Healthcare Limited