RISPERIDONE TABLET, ORALLY DISINTEGRATING [CADILA HEALTHCARE LIMITED]

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RISPERIDONE TABLET, ORALLY DISINTEGRATING [CADILA HEALTHCARE LIMITED]
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NDC 65841-640-06, 65841-641-06, 65841-642-06
Set ID 1522f0b9-2bbc-4785-bada-fa6ae7986bb4
Category HUMAN PRESCRIPTION DRUG LABEL
Packager Cadila Healthcare Limited
Generic Name
Product Class Atypical Antipsychotic
Product Number
Application Number ANDA078516
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  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 65841-640-06 in bottle of 30 tablets

    Risperidone Orally Disintegrating Tablets, 0.5 mg

    Rx only

    30 tablets

    Risperidone Orally Disintegrating Tablets

    NDC 65841-641-06 in bottle of 30 tablets

    Risperidone Orally Disintegrating Tablets, 1 mg

    Rx only

    30 tablets

    Risperidone Orally Disintegrating Tablets

    NDC 65841-642-06 in bottle of 30 tablets

    Risperidone Orally Disintegrating Tablets, 2 mg

    Rx only

    30 tablets

    Risperidone Orally Disintegrating Tablets
  • INGREDIENTS AND APPEARANCE
    RISPERIDONE 
    risperidone tablet, orally disintegrating
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-640
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    RISPERIDONE (UNII: L6UH7ZF8HC) (RISPERIDONE - UNII:L6UH7ZF8HC) RISPERIDONE0.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    ASPARTAME (UNII: Z0H242BBR1)  
    CALCIUM STEARATE (UNII: 776XM7047L)  
    CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
    MANNITOL (UNII: 3OWL53L36A)  
    PEPPERMINT (UNII: V95R5KMY2B)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER (UNII: 905HNO1SIH)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
    ShapeROUND (ROUND) Size6mm
    FlavorPEPPERMINT (FLAVOR FIRMENICH POWDER PEPPERMINT) Imprint Code ZD;22
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-640-0630 in 1 BOTTLE; Type 0: Not a Combination Product06/29/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07851606/29/2010
    RISPERIDONE 
    risperidone tablet, orally disintegrating
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-641
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    RISPERIDONE (UNII: L6UH7ZF8HC) (RISPERIDONE - UNII:L6UH7ZF8HC) RISPERIDONE1 mg
    Inactive Ingredients
    Ingredient NameStrength
    ASPARTAME (UNII: Z0H242BBR1)  
    CALCIUM STEARATE (UNII: 776XM7047L)  
    CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
    MANNITOL (UNII: 3OWL53L36A)  
    PEPPERMINT (UNII: V95R5KMY2B)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER (UNII: 905HNO1SIH)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
    ShapeROUND (ROUND) Size8mm
    FlavorPEPPERMINT (FLAVOR FIRMENICH POWDER PEPPERMINT) Imprint Code ZD;21
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-641-0630 in 1 BOTTLE; Type 0: Not a Combination Product06/29/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07851606/29/2010
    RISPERIDONE 
    risperidone tablet, orally disintegrating
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-642
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    RISPERIDONE (UNII: L6UH7ZF8HC) (RISPERIDONE - UNII:L6UH7ZF8HC) RISPERIDONE2 mg
    Inactive Ingredients
    Ingredient NameStrength
    ASPARTAME (UNII: Z0H242BBR1)  
    CALCIUM STEARATE (UNII: 776XM7047L)  
    CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
    MANNITOL (UNII: 3OWL53L36A)  
    PEPPERMINT (UNII: V95R5KMY2B)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER (UNII: 905HNO1SIH)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
    ShapeROUND (ROUND) Size10mm
    FlavorPEPPERMINT (FLAVOR FIRMENICH POWDER PEPPERMINT) Imprint Code ZD;20
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-642-0630 in 1 BOTTLE; Type 0: Not a Combination Product06/29/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07851606/29/2010
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198ANALYSIS(65841-640, 65841-641, 65841-642) , MANUFACTURE(65841-640, 65841-641, 65841-642)
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