Label: RISPERIDONE tablet, film coated

  • NDC Code(s): 65841-665-01, 65841-665-05, 65841-665-06, 65841-665-10, view more
    65841-665-14, 65841-665-16, 65841-666-01, 65841-666-05, 65841-666-06, 65841-666-10, 65841-666-14, 65841-666-16, 65841-667-01, 65841-667-05, 65841-667-06, 65841-667-10, 65841-667-14, 65841-667-16, 65841-668-01, 65841-668-05, 65841-668-06, 65841-668-10, 65841-668-14, 65841-668-16, 65841-669-01, 65841-669-05, 65841-669-06, 65841-669-10, 65841-669-14, 65841-669-16, 65841-670-01, 65841-670-05, 65841-670-06, 65841-670-10, 65841-670-14, 65841-670-16
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 14, 2020

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

  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Risperidone Tablets USP, 0.25 mg

    NDC 65841-665-14

    60 tablets

    Rx only

    image

    Risperidone Tablets USP, 0.5 mg

    NDC 65841-666-14

    60 tablets

    Rx only

    image

    Risperidone Tablets USP, 1 mg

    NDC 65841-667-14

    60 Tablets

    Rx only

    image

    Risperidone Tablets USP, 2 mg

    NDC 65841-668-14

    60 Tablets

    Rx only

    image

    Risperidone Tablets USP, 3 mg

    NDC 65841-669-14

    60 Tablets

    Rx only

    image

    Risperidone Tablets USP, 4 mg

    NDC 65841-670-14

    60 Tablets

    Rx only

    image
  • INGREDIENTS AND APPEARANCE
    RISPERIDONE 
    risperidone tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-665
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    RISPERIDONE (UNII: L6UH7ZF8HC) (RISPERIDONE - UNII:L6UH7ZF8HC) RISPERIDONE0.25 mg
    Inactive Ingredients
    Ingredient NameStrength
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorYELLOW (DARK YELLOW) Scoreno score
    ShapeROUND (ROUND) Size5mm
    FlavorImprint Code Z;4
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-665-0630 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
    2NDC:65841-665-1460 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
    3NDC:65841-665-1690 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
    4NDC:65841-665-01100 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
    5NDC:65841-665-05500 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
    6NDC:65841-665-101000 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07804011/13/2008
    RISPERIDONE 
    risperidone tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-666
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    RISPERIDONE (UNII: L6UH7ZF8HC) (RISPERIDONE - UNII:L6UH7ZF8HC) RISPERIDONE0.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorRED (RED BROWN) Scoreno score
    ShapeROUND (ROUND) Size5mm
    FlavorImprint Code Z;6
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-666-0630 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
    2NDC:65841-666-1460 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
    3NDC:65841-666-1690 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
    4NDC:65841-666-01100 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
    5NDC:65841-666-05500 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
    6NDC:65841-666-101000 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07804011/13/2008
    RISPERIDONE 
    risperidone tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-667
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    RISPERIDONE (UNII: L6UH7ZF8HC) (RISPERIDONE - UNII:L6UH7ZF8HC) RISPERIDONE1 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
    ShapeROUND (ROUND) Size6mm
    FlavorImprint Code ZC;75
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-667-0630 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
    2NDC:65841-667-1460 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
    3NDC:65841-667-1690 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
    4NDC:65841-667-01100 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
    5NDC:65841-667-05500 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
    6NDC:65841-667-101000 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07804011/13/2008
    RISPERIDONE 
    risperidone tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-668
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    RISPERIDONE (UNII: L6UH7ZF8HC) (RISPERIDONE - UNII:L6UH7ZF8HC) RISPERIDONE2 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorORANGE (ORANGE) Scoreno score
    ShapeROUND (ROUND) Size8mm
    FlavorImprint Code ZC;76
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-668-0630 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
    2NDC:65841-668-1460 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
    3NDC:65841-668-1690 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
    4NDC:65841-668-01100 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
    5NDC:65841-668-05500 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
    6NDC:65841-668-101000 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07804011/13/2008
    RISPERIDONE 
    risperidone tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-669
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    RISPERIDONE (UNII: L6UH7ZF8HC) (RISPERIDONE - UNII:L6UH7ZF8HC) RISPERIDONE3 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorYELLOW (YELLOW) Scoreno score
    ShapeROUND (ROUND) Size10mm
    FlavorImprint Code ZC;77
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-669-0630 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
    2NDC:65841-669-1460 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
    3NDC:65841-669-1690 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
    4NDC:65841-669-01100 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
    5NDC:65841-669-05500 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
    6NDC:65841-669-101000 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07804011/12/2008
    RISPERIDONE 
    risperidone tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-670
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    RISPERIDONE (UNII: L6UH7ZF8HC) (RISPERIDONE - UNII:L6UH7ZF8HC) RISPERIDONE4 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorGREEN (GREEN) Scoreno score
    ShapeROUND (ROUND) Size11mm
    FlavorImprint Code ZC;78
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-670-0630 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
    2NDC:65841-670-1460 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
    3NDC:65841-670-1690 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
    4NDC:65841-670-01100 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
    5NDC:65841-670-05500 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
    6NDC:65841-670-101000 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07804011/13/2008
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198ANALYSIS(65841-665, 65841-666, 65841-667, 65841-668, 65841-669, 65841-670) , MANUFACTURE(65841-665, 65841-666, 65841-667, 65841-668, 65841-669, 65841-670)