Label: HEXATRIONE 2%- triamcinolone hexacetonide injection, suspension

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Unapproved drug for use in drug shortage

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated May 26, 2026

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  • HOW SUPPLIED

    NDC 59137-570-01

    • 2 mL single-dose ampoule (40 mg/2mL). One ampoule per carton.
  • PRINCIPAL DISPLAY PANEL

    20 mg/mL (2 mL Ampoule) - Ampoule Label

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    20 mg/mL (2 mL Ampoule) - Carton Label

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  • INGREDIENTS AND APPEARANCE
    HEXATRIONE  2%
    triamcinolone hexacetonide injection, suspension
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:59137-570
    Route of AdministrationINTRA-ARTICULAR
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRIAMCINOLONE HEXACETONIDE (UNII: I7GT1U99Y9) (TRIAMCINOLONE ACETONIDE - UNII:F446C597KA) TRIAMCINOLONE HEXACETONIDE40 mg  in 2 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBITOL SOLUTION 70% (UNII: 8KW3E207O2)  
    WATER (UNII: 059QF0KO0R)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59137-570-011 in 1 CARTON05/05/202605/31/2028
    12 mL in 1 AMPULE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug for use in drug shortage03/03/2021
    Labeler - Medexus Pharma, Inc. (078811131)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fisiopharma SRL441067444manufacture(59137-570)