SPL MEDGUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1451-1

Aripiprazole Tablets, 2 mg

100 tablets

Rx only

NDC 70771-1452-1

Aripiprazole Tablets, 5 mg

100 tablets

Rx only

NDC 70771-1453-9

Aripiprazole Tablets, 10 mg

90 tablets

Rx only

NDC 70771-1454-9

Aripiprazole Tablets, 15 mg

90 tablets

Rx only

NDC 70771-1455-9

Aripiprazole Tablets, 20 mg

90 tablets

Rx only

NDC 70771-1456-9

Aripiprazole Tablets, 30 mg

90 tablets

Rx only

ARIPIPRAZOLE
aripiprazole tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1452
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ARIPIPRAZOLE (UNII: 82VFR53I78) (ARIPIPRAZOLE - UNII:82VFR53I78)	ARIPIPRAZOLE	5 mg

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

Product Characteristics
Color	WHITE (WHITE TO OFF-WHITE)	Score	no score
Shape	FREEFORM (BARREL)	Size	8mm
Flavor	PEPPERMINT (FLAVOR FIRMENICH POWDER PEPPERMINT)	Imprint Code	ZE;13
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1452-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	06/04/2019
2	NDC:70771-1452-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	06/04/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA090472	06/04/2019

ARIPIPRAZOLE
aripiprazole tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1453
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)
CROSPOVIDONE (UNII: 2S7830E561)
PEPPERMINT (UNII: V95R5KMY2B)
MANNITOL (UNII: 3OWL53L36A)

Product Characteristics
Color	WHITE (WHITE TO OFF-WHITE)	Score	no score
Shape	CAPSULE (CAPSULE)	Size	8mm
Flavor	PEPPERMINT (FLAVOR FIRMENICH POWDER PEPPERMINT)	Imprint Code	ZE;4
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1453-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	06/04/2019
2	NDC:70771-1453-6	60 in 1 BOTTLE; Type 0: Not a Combination Product	06/04/2019
3	NDC:70771-1453-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	06/04/2019
4	NDC:70771-1453-7	120 in 1 BOTTLE; Type 0: Not a Combination Product	06/04/2019
5	NDC:70771-1453-0	1000 in 1 BOTTLE; Type 0: Not a Combination Product	06/04/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA090472	06/04/2019

ARIPIPRAZOLE
aripiprazole tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1454
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)
PEPPERMINT (UNII: V95R5KMY2B)
MANNITOL (UNII: 3OWL53L36A)

Product Characteristics
Color	WHITE (WHITE TO OFF-WHITE)	Score	no score
Shape	ROUND (ROUND)	Size	8mm
Flavor	PEPPERMINT (FLAVOR FIRMENICH POWDER PEPPERMINT)	Imprint Code	ZE;14
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1454-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	06/04/2019
2	NDC:70771-1454-6	60 in 1 BOTTLE; Type 0: Not a Combination Product	06/04/2019
3	NDC:70771-1454-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	06/04/2019
4	NDC:70771-1454-7	120 in 1 BOTTLE; Type 0: Not a Combination Product	06/04/2019
5	NDC:70771-1454-0	1000 in 1 BOTTLE; Type 0: Not a Combination Product	06/04/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA090472	06/04/2019

ARIPIPRAZOLE
aripiprazole tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1455
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)
PEPPERMINT (UNII: V95R5KMY2B)
MANNITOL (UNII: 3OWL53L36A)

Product Characteristics
Color	WHITE (WHITE TO OFF-WHITE)	Score	no score
Shape	FREEFORM (BARREL)	Size	10mm
Flavor	PEPPERMINT (FLAVOR FIRMENICH POWDER PEPPERMINT)	Imprint Code	ZE;15
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1455-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	06/04/2019
2	NDC:70771-1455-6	60 in 1 BOTTLE; Type 0: Not a Combination Product	06/04/2019
3	NDC:70771-1455-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	06/04/2019
4	NDC:70771-1455-7	120 in 1 BOTTLE; Type 0: Not a Combination Product	06/04/2019
5	NDC:70771-1455-0	1000 in 1 BOTTLE; Type 0: Not a Combination Product	06/04/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA090472	06/04/2019

ARIPIPRAZOLE
aripiprazole tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1456
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)
PEPPERMINT (UNII: V95R5KMY2B)
MANNITOL (UNII: 3OWL53L36A)

Product Characteristics
Color	WHITE (WHITE TO OFF-WHITE)	Score	no score
Shape	ROUND (ROUND)	Size	10mm
Flavor	PEPPERMINT (FLAVOR FIRMENICH POWDER PEPPERMINT)	Imprint Code	ZE;16
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1456-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	06/04/2019
2	NDC:70771-1456-6	60 in 1 BOTTLE; Type 0: Not a Combination Product	06/04/2019
3	NDC:70771-1456-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	06/04/2019
4	NDC:70771-1456-7	120 in 1 BOTTLE; Type 0: Not a Combination Product	06/04/2019
5	NDC:70771-1456-0	1000 in 1 BOTTLE; Type 0: Not a Combination Product	06/04/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA090472	06/04/2019

ARIPIPRAZOLE
aripiprazole tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1451
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ARIPIPRAZOLE (UNII: 82VFR53I78) (ARIPIPRAZOLE - UNII:82VFR53I78)	ARIPIPRAZOLE	2 mg

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

Product Characteristics
Color	WHITE (WHITE TO OFF-WHITE)	Score	no score
Shape	CAPSULE (CAPSULE)	Size	6mm
Flavor		Imprint Code	L1
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1451-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	06/04/2019
2	NDC:70771-1451-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	06/04/2019
3	NDC:70771-1451-5	500 in 1 BOTTLE; Type 0: Not a Combination Product	06/04/2019
4	NDC:70771-1451-4	10 in 1 CARTON	06/04/2019
4		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA090472	06/04/2019

Labeler - Zydus Lifesciences Limited (918596198)

Registrant - Zydus Lifesciences Limited (918596198)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		918596198	ANALYSIS(70771-1451, 70771-1452, 70771-1453, 70771-1454, 70771-1455, 70771-1456) , MANUFACTURE(70771-1451, 70771-1452, 70771-1453, 70771-1454, 70771-1455, 70771-1456)

ARIPIPRAZOLE TABLETS

SPL MEDGUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL