Label: HYDROXYCHLOROQUINE SULFATE tablet, film coated

  • NDC Code(s): 65841-633-01, 65841-633-05, 65841-633-30
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL

Drug Label Information

Updated April 21, 2020

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  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 65841-633-01 in bottle of 100 tablets

    Hydroxychloroquine Sulfate Tablets USP, 200 mg

    Rx only

    100 tablets

    Hydroxychloroquine sulfate tablets
  • INGREDIENTS AND APPEARANCE
    HYDROXYCHLOROQUINE SULFATE 
    hydroxychloroquine sulfate tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-633
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROXYCHLOROQUINE SULFATE (UNII: 8Q2869CNVH) (HYDROXYCHLOROQUINE - UNII:4QWG6N8QKH) HYDROXYCHLOROQUINE SULFATE200 mg
    Inactive Ingredients
    Ingredient NameStrength
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
    ShapeOVAL (CAPSULE) Size13mm
    FlavorImprint Code ZC38
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-633-01100 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2008
    2NDC:65841-633-05500 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2008
    3NDC:65841-633-3010 in 1 CARTON01/03/2008
    310 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04065701/03/2008
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198ANALYSIS(65841-633) , MANUFACTURE(65841-633)