Label: TEGSEDI- inotersen injection, solution

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Export only

Drug Label Information

Updated August 13, 2025

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  • PRINCIPAL DISPLAY PANEL

    139-105-300 EXP

  • INGREDIENTS AND APPEARANCE
    TEGSEDI 
    inotersen injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:61434-031
    Route of AdministrationSUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    INOTERSEN SODIUM (UNII: 950736UC77) (INOTERSEN - UNII:0IEO0F56LV) INOTERSEN284 mg  in 1.5 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61434-031-03800 in 1 CASE10/05/2018
    11.5 mL in 1 SYRINGE; Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Export only10/05/2018
    Labeler - Catalent Indiana, LLC (172209277)
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