ARIPIPRAZOLE- aripiprazole tablet 
Cadila Healthcare Limited

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ARIPIPRAZOLE TABLETS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1451-1

Aripiprazole Tablets, 2 mg

100 tablets

Rx only

Aripiprazole  Tablets

NDC 70771-1452-1

Aripiprazole Tablets, 5 mg

100 tablets

Rx only

Aripiprazole  Tablets

NDC 70771-1453-9

Aripiprazole Tablets, 10 mg

90 tablets

Rx only

Aripiprazole  Tablets

NDC 70771-1454-9

Aripiprazole Tablets, 15 mg

90 tablets

Rx only

Aripiprazole Tablets

NDC 70771-1455-9

Aripiprazole Tablets, 20 mg

90 tablets

Rx only

Aripiprazole Tablets

NDC 70771-1456-9

Aripiprazole Tablets, 30 mg

90 tablets

Rx only

Aripiprazole Tablets
ARIPIPRAZOLE 
aripiprazole tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1452
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARIPIPRAZOLE (UNII: 82VFR53I78) (ARIPIPRAZOLE - UNII:82VFR53I78) ARIPIPRAZOLE5 mg
Inactive Ingredients
Ingredient NameStrength
ASPARTAME (UNII: Z0H242BBR1)  
CALCIUM STEARATE (UNII: 776XM7047L)  
CROSPOVIDONE (UNII: 2S7830E561)  
PEPPERMINT (UNII: V95R5KMY2B)  
MANNITOL (UNII: 3OWL53L36A)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeFREEFORM (BARREL) Size8mm
FlavorPEPPERMINT (FLAVOR FIRMENICH POWDER PEPPERMINT) Imprint Code ZE;13
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1452-330 in 1 BOTTLE; Type 0: Not a Combination Product06/04/2019
2NDC:70771-1452-1100 in 1 BOTTLE; Type 0: Not a Combination Product06/04/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09047206/04/2019
ARIPIPRAZOLE 
aripiprazole tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1453
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARIPIPRAZOLE (UNII: 82VFR53I78) (ARIPIPRAZOLE - UNII:82VFR53I78) ARIPIPRAZOLE10 mg
Inactive Ingredients
Ingredient NameStrength
ASPARTAME (UNII: Z0H242BBR1)  
CALCIUM STEARATE (UNII: 776XM7047L)  
CROSPOVIDONE (UNII: 2S7830E561)  
PEPPERMINT (UNII: V95R5KMY2B)  
MANNITOL (UNII: 3OWL53L36A)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeCAPSULE (CAPSULE) Size8mm
FlavorPEPPERMINT (FLAVOR FIRMENICH POWDER PEPPERMINT) Imprint Code ZE;4
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1453-330 in 1 BOTTLE; Type 0: Not a Combination Product06/04/2019
2NDC:70771-1453-660 in 1 BOTTLE; Type 0: Not a Combination Product06/04/2019
3NDC:70771-1453-990 in 1 BOTTLE; Type 0: Not a Combination Product06/04/2019
4NDC:70771-1453-7120 in 1 BOTTLE; Type 0: Not a Combination Product06/04/2019
5NDC:70771-1453-01000 in 1 BOTTLE; Type 0: Not a Combination Product06/04/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09047206/04/2019
ARIPIPRAZOLE 
aripiprazole tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1454
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARIPIPRAZOLE (UNII: 82VFR53I78) (ARIPIPRAZOLE - UNII:82VFR53I78) ARIPIPRAZOLE15 mg
Inactive Ingredients
Ingredient NameStrength
ASPARTAME (UNII: Z0H242BBR1)  
CALCIUM STEARATE (UNII: 776XM7047L)  
CROSPOVIDONE (UNII: 2S7830E561)  
PEPPERMINT (UNII: V95R5KMY2B)  
MANNITOL (UNII: 3OWL53L36A)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeROUND (ROUND) Size8mm
FlavorPEPPERMINT (FLAVOR FIRMENICH POWDER PEPPERMINT) Imprint Code ZE;14
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1454-330 in 1 BOTTLE; Type 0: Not a Combination Product06/04/2019
2NDC:70771-1454-660 in 1 BOTTLE; Type 0: Not a Combination Product06/04/2019
3NDC:70771-1454-990 in 1 BOTTLE; Type 0: Not a Combination Product06/04/2019
4NDC:70771-1454-7120 in 1 BOTTLE; Type 0: Not a Combination Product06/04/2019
5NDC:70771-1454-01000 in 1 BOTTLE; Type 0: Not a Combination Product06/04/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09047206/04/2019
ARIPIPRAZOLE 
aripiprazole tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1455
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARIPIPRAZOLE (UNII: 82VFR53I78) (ARIPIPRAZOLE - UNII:82VFR53I78) ARIPIPRAZOLE20 mg
Inactive Ingredients
Ingredient NameStrength
ASPARTAME (UNII: Z0H242BBR1)  
CALCIUM STEARATE (UNII: 776XM7047L)  
CROSPOVIDONE (UNII: 2S7830E561)  
PEPPERMINT (UNII: V95R5KMY2B)  
MANNITOL (UNII: 3OWL53L36A)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeFREEFORM (BARREL) Size10mm
FlavorPEPPERMINT (FLAVOR FIRMENICH POWDER PEPPERMINT) Imprint Code ZE;15
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1455-330 in 1 BOTTLE; Type 0: Not a Combination Product06/04/2019
2NDC:70771-1455-660 in 1 BOTTLE; Type 0: Not a Combination Product06/04/2019
3NDC:70771-1455-990 in 1 BOTTLE; Type 0: Not a Combination Product06/04/2019
4NDC:70771-1455-7120 in 1 BOTTLE; Type 0: Not a Combination Product06/04/2019
5NDC:70771-1455-01000 in 1 BOTTLE; Type 0: Not a Combination Product06/04/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09047206/04/2019
ARIPIPRAZOLE 
aripiprazole tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1456
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARIPIPRAZOLE (UNII: 82VFR53I78) (ARIPIPRAZOLE - UNII:82VFR53I78) ARIPIPRAZOLE30 mg
Inactive Ingredients
Ingredient NameStrength
ASPARTAME (UNII: Z0H242BBR1)  
CALCIUM STEARATE (UNII: 776XM7047L)  
CROSPOVIDONE (UNII: 2S7830E561)  
PEPPERMINT (UNII: V95R5KMY2B)  
MANNITOL (UNII: 3OWL53L36A)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeROUND (ROUND) Size10mm
FlavorPEPPERMINT (FLAVOR FIRMENICH POWDER PEPPERMINT) Imprint Code ZE;16
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1456-330 in 1 BOTTLE; Type 0: Not a Combination Product06/04/2019
2NDC:70771-1456-660 in 1 BOTTLE; Type 0: Not a Combination Product06/04/2019
3NDC:70771-1456-990 in 1 BOTTLE; Type 0: Not a Combination Product06/04/2019
4NDC:70771-1456-7120 in 1 BOTTLE; Type 0: Not a Combination Product06/04/2019
5NDC:70771-1456-01000 in 1 BOTTLE; Type 0: Not a Combination Product06/04/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09047206/04/2019
ARIPIPRAZOLE 
aripiprazole tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1451
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARIPIPRAZOLE (UNII: 82VFR53I78) (ARIPIPRAZOLE - UNII:82VFR53I78) ARIPIPRAZOLE2 mg
Inactive Ingredients
Ingredient NameStrength
ASPARTAME (UNII: Z0H242BBR1)  
CALCIUM STEARATE (UNII: 776XM7047L)  
CROSPOVIDONE (UNII: 2S7830E561)  
MANNITOL (UNII: 3OWL53L36A)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeCAPSULE (CAPSULE) Size6mm
FlavorImprint Code L1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1451-330 in 1 BOTTLE; Type 0: Not a Combination Product06/04/2019
2NDC:70771-1451-1100 in 1 BOTTLE; Type 0: Not a Combination Product06/04/2019
3NDC:70771-1451-5500 in 1 BOTTLE; Type 0: Not a Combination Product06/04/2019
4NDC:70771-1451-410 in 1 CARTON06/04/2019
410 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09047206/04/2019
Labeler - Cadila Healthcare Limited (918596198)
Registrant - Cadila Healthcare Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Cadila Healthcare Limited918596198ANALYSIS(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)

Revised: 8/2020
Document Id: 20b8d0ef-b9a8-4cbb-a420-cf9d8e3b5827
Set id: 4970063e-778f-4c78-b518-ef9624a65f22
Version: 3
Effective Time: 20200813
 
Cadila Healthcare Limited