Label: MESALAMINE suppository

  • NDC Code(s): 70771-1513-6, 70771-1513-7
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 1, 2020

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  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1513-6

    Mesalamine suppositories, 1000 mg

    30 rectal suppositories

    Rx only

    Blister label

    Image

    NDC 70771-1513-7

    Mesalamine rectal suppositories, 1000 mg

    30 rectal suppositories

    Rx only

    Carton label

    Image

  • INGREDIENTS AND APPEARANCE
    MESALAMINE 
    mesalamine suppository
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1513
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MESALAMINE (UNII: 4Q81I59GXC) (MESALAMINE - UNII:4Q81I59GXC) MESALAMINE1000 mg
    Inactive Ingredients
    Ingredient NameStrength
    FAT, HARD (UNII: 8334LX7S21)  
    Product Characteristics
    ColorWHITE (OFF WHITE TO LIGHT TAN COLORED) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1513-75 in 1 POUCH02/14/2020
    1NDC:70771-1513-66 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20895302/14/2020
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (650650802)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited650650802ANALYSIS(70771-1513) , MANUFACTURE(70771-1513)