Label: MESALAMINE suppository

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

Drug Label Information

Updated October 31, 2022

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

View All Sections
  • 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 - Zydus Lifesciences Limited (918596198)
    Registrant - Zydus Lifesciences Limited (650650802)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited650650802ANALYSIS(70771-1513) , MANUFACTURE(70771-1513)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!