Label: METHOTREXATE tablet

  • NDC Code(s): 70771-1058-0, 70771-1058-1, 70771-1058-2, 70771-1058-3, view more
    70771-1058-5, 70771-1058-7, 70771-1058-9
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated July 28, 2020

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  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1058-1

    Methotrexate tablets, USP   2.5 mg

    Rx only

    36 tablets

    Methotrexate tablets, USP
  • INGREDIENTS AND APPEARANCE
    METHOTREXATE 
    methotrexate tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1058
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHOTREXATE (UNII: YL5FZ2Y5U1) (METHOTREXATE - UNII:YL5FZ2Y5U1) METHOTREXATE2.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorYELLOW (YELLOW) Score2 pieces
    ShapeROUND (ROUND) Size6mm
    FlavorImprint Code L2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1058-336 in 1 BOTTLE; Type 0: Not a Combination Product02/09/2017
    2NDC:70771-1058-990 in 1 BOTTLE; Type 0: Not a Combination Product02/09/2017
    3NDC:70771-1058-1100 in 1 BOTTLE; Type 0: Not a Combination Product02/09/2017
    4NDC:70771-1058-5500 in 1 BOTTLE; Type 0: Not a Combination Product02/09/2017
    5NDC:70771-1058-01000 in 1 BOTTLE; Type 0: Not a Combination Product02/09/2017
    6NDC:70771-1058-7100 in 1 CARTON02/09/2017
    6NDC:70771-1058-21 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20781202/09/2017
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Zydus Pharmaceuticals (USA) Inc. (156861945)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited863362789ANALYSIS(70771-1058) , MANUFACTURE(70771-1058)