Label: INDOMETHACIN capsule, extended release

  • NDC Code(s): 70771-1203-0, 70771-1203-1, 70771-1203-2, 70771-1203-4, view more
    70771-1203-5, 70771-1203-6
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 31, 2020

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  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1203-6

    Indomethacin Extended-release Capsules, 75 mg

    60 Capsules

    Rx only

    label
  • INGREDIENTS AND APPEARANCE
    INDOMETHACIN 
    indomethacin capsule, extended release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1203
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    INDOMETHACIN (UNII: XXE1CET956) (INDOMETHACIN - UNII:XXE1CET956) INDOMETHACIN75 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    GELATIN (UNII: 2G86QN327L)  
    SHELLAC (UNII: 46N107B71O)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    AMMONIA (UNII: 5138Q19F1X)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorBLUE (DARK BLUE) , BLUE (DARK BLUE) Scoreno score
    ShapeCAPSULE (CAPSULE) Size19mm
    FlavorImprint Code ZA;79;75mg
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1203-660 in 1 BOTTLE; Type 0: Not a Combination Product02/08/2018
    2NDC:70771-1203-1100 in 1 BOTTLE; Type 0: Not a Combination Product02/08/2018
    3NDC:70771-1203-5500 in 1 BOTTLE; Type 0: Not a Combination Product02/08/2018
    4NDC:70771-1203-01000 in 1 BOTTLE; Type 0: Not a Combination Product02/08/2018
    5NDC:70771-1203-410 in 1 CARTON02/08/2018
    5NDC:70771-1203-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20271102/08/2018
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198ANALYSIS(70771-1203) , MANUFACTURE(70771-1203)