Label: ARIPIPRAZOLE tablet

  • NDC Code(s): 70771-1451-1, 70771-1451-3, 70771-1451-4, 70771-1451-5, view more
    70771-1452-1, 70771-1452-3, 70771-1453-0, 70771-1453-3, 70771-1453-6, 70771-1453-7, 70771-1453-9, 70771-1454-0, 70771-1454-3, 70771-1454-6, 70771-1454-7, 70771-1454-9, 70771-1455-0, 70771-1455-3, 70771-1455-6, 70771-1455-7, 70771-1455-9, 70771-1456-0, 70771-1456-3, 70771-1456-6, 70771-1456-7, 70771-1456-9
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 13, 2020

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

  • 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
  • INGREDIENTS AND APPEARANCE
    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)