Label: ARIPIPRAZOLE tablet, orally disintegrating

  • NDC Code(s): 76483-100-00, 76483-100-01, 76483-100-02, 76483-100-03, view more
    76483-101-00, 76483-101-01, 76483-101-02, 76483-101-03, 76483-102-00, 76483-102-01, 76483-102-02, 76483-102-03, 76483-103-00, 76483-103-01, 76483-103-02, 76483-103-03
  • Packager: SQUARE PHARMACEUTICALS LIMITED
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated June 15, 2022

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  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 76483-100-00

    Aripiprazole Orally Disintegrating Tablets, USP 10 mg

    30 Tablets

    Rx Only

    Aripiprazole Orally Disintegrating Tablets, USP 10 mg; 30 counts

    NDC 76483-100-01

    Aripiprazole Orally Disintegrating Tablets, USP 10 mg

    60 Tablets

    Rx Only

    Aripiprazole Orally Disintegrating Tablets, USP 10 mg; 60 Counts

    NDC 76483-100-02

    Aripiprazole Orally Disintegrating Tablets, USP 10 mg

    90 Tablets

    Rx Only

    Aripiprazole Orally Disintegrating Tablets, USP 10 mg; 90 Counts

    NDC 76483-100-03

    Aripiprazole Orally Disintegrating Tablets, USP 10 mg

    120 Tablets

    Rx Only

    Aripiprazole Orally Disintegrating Tablets, USP 10 mg; 120 Counts

    NDC 76483-101-00

    Aripiprazole Orally Disintegrating Tablets, USP 15 mg

    30 Tablets

    Rx Only

    Aripiprazole Orally Disintegrating Tablets, USP 15 mg; 30 Counts

    NDC 76483-101-01

    Aripiprazole Orally Disintegrating Tablets, USP 15 mg

    60 Tablets

    Rx Only

    Aripiprazole Orally Disintegrating Tablets, USP 15 mg; 60 Counts

    NDC 76483-101-02

    Aripiprazole Orally Disintegrating Tablets, USP 15 mg

    90 Tablets

    Rx Only

    Aripiprazole Orally Disintegrating Tablets, USP 15 mg; 90 Counts

    NDC 76483-101-03

    Aripiprazole Orally Disintegrating Tablets, USP 15 mg

    120 Tablets

    Rx Only

    Aripiprazole Orally Disintegrating Tablets, USP 15 mg; 120 Counts

    NDC 76483-102-00

    Aripiprazole Orally Disintegrating Tablets, USP 20 mg

    30 Tablets

    Rx Only

    Aripiprazole Orally Disintegrating Tablets, USP 20 mg; 30 Counts

    NDC 76483-102-01

    Aripiprazole Orally Disintegrating Tablets, USP 20 mg

    60 Tablets

    Rx Only

    Aripiprazole Orally Disintegrating Tablets, USP 20 mg; 60 Counts

    NDC 76483-102-02

    Aripiprazole Orally Disintegrating Tablets, USP 20 mg

    90 Tablets

    Rx Only

    Aripiprazole Orally Disintegrating Tablets, USP 20 mg; 90 Counts

    NDC 76483-102-03

    Aripiprazole Orally Disintegrating Tablets, USP 20 mg

    120 Tablets

    Rx Only

    Aripiprazole Orally Disintegrating Tablets, USP 20 mg; 120 Counts

    NDC 76483-103-00

    Aripiprazole Orally Disintegrating Tablets, USP 30 mg

    30 Tablets

    Rx Only

    Aripiprazole Orally Disintegrating Tablets, USP 30 mg; 30 Counts

    NDC 76483-103-01

    Aripiprazole Orally Disintegrating Tablets, USP 30 mg

    60 Tablets

    Rx Only

    Aripiprazole Orally Disintegrating Tablets, USP 30 mg; 60 Counts

    NDC 76483-103-02

    Aripiprazole Orally Disintegrating Tablets, USP 30 mg

    90 Tablets

    Rx Only

    Aripiprazole Orally Disintegrating Tablets, USP 30 mg; 90 Counts

    NDC 76483-103-03

    Aripiprazole Orally Disintegrating Tablets, USP 30 mg

    120 Tablets

    Rx Only

    Aripiprazole Orally Disintegrating Tablets, USP 30 mg; 120 Counts
  • INGREDIENTS AND APPEARANCE
    ARIPIPRAZOLE 
    aripiprazole tablet, orally disintegrating
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:76483-100
    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
    ShapeCAPSULESize8mm
    FlavorPEPPERMINT (FLAVOR FIRMENICH POWDER PEPPERMINT) Imprint Code ZF;41
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76483-100-0030 in 1 BOTTLE; Type 0: Not a Combination Product06/20/2022
    2NDC:76483-100-0160 in 1 BOTTLE; Type 0: Not a Combination Product06/20/2022
    3NDC:76483-100-0290 in 1 BOTTLE; Type 0: Not a Combination Product06/20/2022
    4NDC:76483-100-03120 in 1 BOTTLE; Type 0: Not a Combination Product06/20/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09016506/20/2022
    ARIPIPRAZOLE 
    aripiprazole tablet, orally disintegrating
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:76483-101
    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
    ShapeROUNDSize8mm
    FlavorPEPPERMINT (FLAVOR FIRMENICH POWDER PEPPERMINT) Imprint Code ZF;42
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76483-101-0030 in 1 BOTTLE; Type 0: Not a Combination Product06/20/2022
    2NDC:76483-101-0160 in 1 BOTTLE; Type 0: Not a Combination Product06/20/2022
    3NDC:76483-101-0290 in 1 BOTTLE; Type 0: Not a Combination Product06/20/2022
    4NDC:76483-101-03120 in 1 BOTTLE; Type 0: Not a Combination Product06/20/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09016506/20/2022
    ARIPIPRAZOLE 
    aripiprazole tablet, orally disintegrating
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:76483-102
    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:76483-102-0030 in 1 BOTTLE; Type 0: Not a Combination Product06/20/2022
    2NDC:76483-102-0160 in 1 BOTTLE; Type 0: Not a Combination Product06/20/2022
    3NDC:76483-102-0290 in 1 BOTTLE; Type 0: Not a Combination Product06/20/2022
    4NDC:76483-102-03120 in 1 BOTTLE; Type 0: Not a Combination Product06/20/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09016506/20/2022
    ARIPIPRAZOLE 
    aripiprazole tablet, orally disintegrating
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:76483-103
    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:76483-103-0030 in 1 BOTTLE; Type 0: Not a Combination Product06/20/2022
    2NDC:76483-103-0160 in 1 BOTTLE; Type 0: Not a Combination Product06/20/2022
    3NDC:76483-103-0290 in 1 BOTTLE; Type 0: Not a Combination Product06/20/2022
    4NDC:76483-103-03120 in 1 BOTTLE; Type 0: Not a Combination Product06/20/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09016506/20/2022
    Labeler - SQUARE PHARMACEUTICALS LIMITED (731487153)
    Registrant - SQUARE PHARMACEUTICALS LIMITED (731487153)
    Establishment
    NameAddressID/FEIBusiness Operations
    SQUARE PHARMACEUTICALS LIMITED731487153ANALYSIS(76483-100, 76483-101, 76483-102, 76483-103) , LABEL(76483-100, 76483-101, 76483-102, 76483-103) , MANUFACTURE(76483-100, 76483-101, 76483-102, 76483-103) , PACK(76483-100, 76483-101, 76483-102, 76483-103)
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