Label: EPURIS- isotretinoin capsule

  • NDC Code(s): 66277-335-10, 66277-335-30, 66277-336-10, 66277-336-30
  • Packager: Galephar Pharmaceutical Research Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Export only

Drug Label Information

Updated December 6, 2024

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  • Epuris 10 mg Box of 3 blister cards

    Epuris Mexico 10 mg

  • Epuris 20 mg Box of 3 blister cards

    Epuris Mexico 20 mg

  • INGREDIENTS AND APPEARANCE
    EPURIS 
    isotretinoin capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:66277-335
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOTRETINOIN (UNII: EH28UP18IF) (ISOTRETINOIN - UNII:EH28UP18IF) ISOTRETINOIN20 mg
    Inactive Ingredients
    Ingredient NameStrength
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    PEG-32 HYDROGENATED PALM GLYCERIDES (UNII: G6EP177239)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    Product Characteristics
    ColorredScoreno score
    ShapeCAPSULESize22mm
    FlavorImprint Code G241;20
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66277-335-303 in 1 BOX10/01/2023
    1NDC:66277-335-1010 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Export only10/01/2023
    EPURIS 
    isotretinoin capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:66277-336
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOTRETINOIN (UNII: EH28UP18IF) (ISOTRETINOIN - UNII:EH28UP18IF) ISOTRETINOIN10 mg
    Inactive Ingredients
    Ingredient NameStrength
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    PEG-32 HYDROGENATED PALM GLYCERIDES (UNII: G6EP177239)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeCAPSULESize18mm
    FlavorImprint Code G240;10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66277-336-303 in 1 BOX10/01/2023
    1NDC:66277-336-1010 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Export only10/01/2023
    Labeler - Galephar Pharmaceutical Research Inc. (003551624)
    Registrant - Galephar Pharmaceutical Research Inc. (968996160)
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