Label: FLUZONE HIGH DOSE NORTHERN HEMISPHERE (influenza a virus a/victoria/4897/2022 ivr-238 (h1n1) antigen (formaldehyde inactivated), influenza a virus a/croatia/10136/rv/2023 (h3n2) antigen (formaldehyde inactivated), and influenza b virus b/michigan/01/2021 antigen- formaldehyde inactivated injection, suspension

  • NDC Code(s): 63552-722-05, 63552-722-10
  • Packager: Patheon Manufacturing Services LLC
  • Category: VACCINE LABEL
  • DEA Schedule: None
  • Marketing Status: Biologic Licensing Application

Drug Label Information

Updated November 4, 2025

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  • PRINCIPAL DISPLAY PANEL

    Fluzone

  • INGREDIENTS AND APPEARANCE
    FLUZONE HIGH DOSE NORTHERN HEMISPHERE 
    influenza a virus a/victoria/4897/2022 ivr-238 (h1n1) antigen (formaldehyde inactivated), influenza a virus a/croatia/10136/rv/2023 (h3n2) antigen (formaldehyde inactivated), and influenza b virus b/michigan/01/2021 antigen (formaldehyde inactivated) injection, suspension
    Product Information
    Product TypeVACCINEItem Code (Source)NDC:63552-722
    Route of AdministrationINTRAMUSCULAR
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    INFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: HQW9FZS4YK) (INFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (H3N2) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:SD82XNG5M6) INFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (H3N2) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)60 ug  in 0.5 mL
    INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: FF9YP4D23C) (INFLUENZA B VIRUS B/MICHIGAN/01/2021 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:CQV855H5FG) INFLUENZA B VIRUS B/MICHIGAN/01/2021 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)60 ug  in 0.5 mL
    INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: AU5C98U4BB) (INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:C46XJT9FQ9) INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)60 ug  in 0.5 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    OCTOXYNOL-9 (UNII: 7JPC6Y25QS)  
    SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)  
    WATER (UNII: 059QF0KO0R)  
    FORMALDEHYDE (UNII: 1HG84L3525)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63552-722-105 in 1 PACKAGE
    1NDC:63552-722-050.5 mL in 1 SYRINGE, GLASS; Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA10391409/01/2025
    Labeler - Patheon Manufacturing Services LLC (079415560)
    Registrant - Patheon Manufacturing Services LLC (062331516)
    Establishment
    NameAddressID/FEIBusiness Operations
    Patheon Manufacturing Services LLC062331516analysis(63552-722) , label(63552-722) , manufacture(63552-722) , pack(63552-722)
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