Label: INDOMETHACIN capsule

  • NDC Code(s): 70771-1004-0, 70771-1004-1, 70771-1004-2, 70771-1004-5, view more
    70771-1005-0, 70771-1005-1, 70771-1005-2, 70771-1005-5
  • 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

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1004-01

    Indomethacin capsules USP, 25 mg

    100 Capsules

    Rx only

    Indomethacin Capsules, USP

    NDC 70771-1005-01

    Indomethacin capsules USP, 50 mg

    100 Capsules

    Rx only

    IndomethacineCapsules, USP
  • INGREDIENTS AND APPEARANCE
    INDOMETHACIN 
    indomethacin capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1004
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    INDOMETHACIN (UNII: XXE1CET956) (INDOMETHACIN - UNII:XXE1CET956) INDOMETHACIN50 mg
    Inactive Ingredients
    Ingredient NameStrength
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    GELATIN (UNII: 2G86QN327L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorGREEN (GREEN) Scoreno score
    ShapeCAPSULE (CAPSULE) Size19mm
    FlavorImprint Code 294;50mg
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1004-1100 in 1 BOTTLE; Type 0: Not a Combination Product07/21/2016
    2NDC:70771-1004-5500 in 1 BOTTLE; Type 0: Not a Combination Product07/21/2016
    3NDC:70771-1004-01000 in 1 BOTTLE; Type 0: Not a Combination Product07/21/2016
    4NDC:70771-1004-210 in 1 BLISTER PACK; Type 0: Not a Combination Product07/21/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09040307/21/2016
    INDOMETHACIN 
    indomethacin capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1005
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    INDOMETHACIN (UNII: XXE1CET956) (INDOMETHACIN - UNII:XXE1CET956) INDOMETHACIN25 mg
    Inactive Ingredients
    Ingredient NameStrength
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    GELATIN (UNII: 2G86QN327L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorGREEN (GREEN) Scoreno score
    ShapeCAPSULE (CAPSULE) Size16mm
    FlavorImprint Code 293;25mg
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1005-1100 in 1 BOTTLE; Type 0: Not a Combination Product07/21/2016
    2NDC:70771-1005-5500 in 1 BOTTLE; Type 0: Not a Combination Product07/21/2016
    3NDC:70771-1005-01000 in 1 BOTTLE; Type 0: Not a Combination Product07/21/2016
    4NDC:70771-1005-210 in 1 BLISTER PACK; Type 0: Not a Combination Product07/21/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09040307/21/2016
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198ANALYSIS(70771-1004, 70771-1005) , MANUFACTURE(70771-1004, 70771-1005)