Label: AZATHIOPRINE tablet

  • NDC Code(s): 65841-602-01, 65841-602-05
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated July 24, 2020

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  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 65841-602-01 in bottle of 100 tablets

    Azathioprine Tablets USP, 50 mg

    100 tablets

    Rx only

    Azathioprine Tablets, USP
  • INGREDIENTS AND APPEARANCE
    AZATHIOPRINE 
    azathioprine tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-602
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AZATHIOPRINE (UNII: MRK240IY2L) (AZATHIOPRINE - UNII:MRK240IY2L) AZATHIOPRINE50 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorYELLOW (YELLOW) Score2 pieces
    ShapeROUND (ROUND) Size8mm
    FlavorImprint Code ZC;59
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-602-01100 in 1 BOTTLE; Type 0: Not a Combination Product07/11/2007
    2NDC:65841-602-05500 in 1 BOTTLE; Type 0: Not a Combination Product07/11/2007
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07762107/11/2007
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198ANALYSIS(65841-602) , MANUFACTURE(65841-602)