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 February 23, 2021

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  • HEALTH CARE PROVIDER LETTER

    DHCP page 1

    DHCP page 2DHCP page 3DHCP page 4DHCP page 5DHCP page 6DHCP page 7

  • 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

    Ampoule Label

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

    Carton

  • 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 CARTON03/03/2021
    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
    Valdepharm260128560manufacture(59137-570)