Label: ARIPIPRAZOLE tablet, orally disintegrating

  • NDC Code(s): 70771-1432-1, 70771-1432-3, 70771-1432-6, 70771-1432-9, view more
    70771-1433-1, 70771-1433-3, 70771-1433-6, 70771-1433-9, 70771-1434-1, 70771-1434-3, 70771-1434-6, 70771-1434-9, 70771-1435-1, 70771-1435-3, 70771-1435-6, 70771-1435-9
  • 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 70771-1432-9

    Aripiprazole Orally Disintegrating Tablets, 10 mg

    90 tablets

    Rx only

    Aripiprazole Orally Disintegrating Tablets

    NDC 70771-1433-9

    Aripiprazole Orally Disintegrating Tablets, 15 mg

    90 tablets

    Rx only

    Aripiprazole Orally Disintegrating Tablets

    NDC 70771-1434-9

    Aripiprazole Orally Disintegrating Tablets, 20 mg

    90 tablets

    Rx only

    Aripiprazole Orally Disintegrating Tablets

    NDC 70771-1435-9

    Aripiprazole Orally Disintegrating Tablets, 30 mg

    90 tablets

    Rx only

    Aripiprazole Orally Disintegrating Tablets
  • INGREDIENTS AND APPEARANCE
    ARIPIPRAZOLE 
    aripiprazole tablet, orally disintegrating
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1432
    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)  
    MANNITOL (UNII: 3OWL53L36A)  
    PEPPERMINT (UNII: V95R5KMY2B)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
    ShapeCAPSULE (CAPSULE) Size8mm
    FlavorPEPPERMINT (FLAVOR FIRMENICH POWDER PEPPERMINT) Imprint Code ZF;41
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1432-330 in 1 BOTTLE; Type 0: Not a Combination Product02/06/2019
    2NDC:70771-1432-660 in 1 BOTTLE; Type 0: Not a Combination Product02/06/2019
    3NDC:70771-1432-990 in 1 BOTTLE; Type 0: Not a Combination Product02/06/2019
    4NDC:70771-1432-1120 in 1 BOTTLE; Type 0: Not a Combination Product02/06/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09016502/06/2019
    ARIPIPRAZOLE 
    aripiprazole tablet, orally disintegrating
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1433
    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)  
    MANNITOL (UNII: 3OWL53L36A)  
    PEPPERMINT (UNII: V95R5KMY2B)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
    ShapeROUND (ROUND) Size8mm
    FlavorPEPPERMINT (FLAVOR FIRMENICH POWDER PEPPERMINT) Imprint Code ZF;42
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1433-330 in 1 BOTTLE; Type 0: Not a Combination Product02/06/2019
    2NDC:70771-1433-660 in 1 BOTTLE; Type 0: Not a Combination Product02/06/2019
    3NDC:70771-1433-990 in 1 BOTTLE; Type 0: Not a Combination Product02/06/2019
    4NDC:70771-1433-1120 in 1 BOTTLE; Type 0: Not a Combination Product02/06/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09016502/06/2019
    ARIPIPRAZOLE 
    aripiprazole tablet, orally disintegrating
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1434
    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)  
    MANNITOL (UNII: 3OWL53L36A)  
    PEPPERMINT (UNII: V95R5KMY2B)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
    ShapeOCTAGON (8 SIDED) (BARREL) Size8mm
    FlavorPEPPERMINT (FLAVOR FIRMENICH POWDER PEPPERMINT) Imprint Code ZF;43
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1434-330 in 1 BOTTLE; Type 0: Not a Combination Product02/06/2019
    2NDC:70771-1434-660 in 1 BOTTLE; Type 0: Not a Combination Product02/06/2019
    3NDC:70771-1434-990 in 1 BOTTLE; Type 0: Not a Combination Product02/06/2019
    4NDC:70771-1434-1120 in 1 BOTTLE; Type 0: Not a Combination Product02/06/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09016502/06/2019
    ARIPIPRAZOLE 
    aripiprazole tablet, orally disintegrating
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1435
    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)  
    MANNITOL (UNII: 3OWL53L36A)  
    PEPPERMINT (UNII: V95R5KMY2B)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
    ShapeROUND (ROUND) Size10mm
    FlavorPEPPERMINT (FLAVOR FIRMENICH POWDER PEPPERMINT) Imprint Code ZF;44
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1435-330 in 1 BOTTLE; Type 0: Not a Combination Product02/06/2019
    2NDC:70771-1435-660 in 1 BOTTLE; Type 0: Not a Combination Product02/06/2019
    3NDC:70771-1435-990 in 1 BOTTLE; Type 0: Not a Combination Product02/06/2019
    4NDC:70771-1435-1120 in 1 BOTTLE; Type 0: Not a Combination Product02/06/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09016502/06/2019
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198ANALYSIS(70771-1432, 70771-1433, 70771-1434, 70771-1435) , MANUFACTURE(70771-1432, 70771-1433, 70771-1434, 70771-1435)