Label: FLUZONE QUADRIVALENT NORTHERN HEMISPHERE (influenza a virus a/victoria/2570/2019 ivr-215 (h1n1) antigen (formaldehyde inactivated), influenza a virus a/darwin/9/2021 san-010 (h3n2) antigen (formaldehyde inactivated), influenza b virus b/phuket/3073/2013 antigen (formaldehyde inactivated), and influenza b virus b/michigan/01/2021 antigen- formaldehyde inactivated injection, suspension

  • NDC Code(s): 83703-044-50, 83703-044-88
  • Packager: Bamboo US BidCo LLC
  • Category: VACCINE LABEL
  • DEA Schedule: None
  • Marketing Status: Biologic Licensing Application

Drug Label Information

Updated June 14, 2024

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  • PRINCIPAL DISPLAY PANEL - 0.5 mL Syringe Package

    2022 – 2023 Formula

    10 Single-Dose
    Prefilled Syringes
    0.5 mL each

    Rx only

    4
    STRAINS

    Influenza Vaccine
    Fluzone ®Quadrivalent

    For 6 months of age and older
    For intramuscular injection only

    SANOFI PASTEUR

    PRINCIPAL DISPLAY PANEL - 0.5 mL Syringe Package - 49281-422-50

  • PRINCIPAL DISPLAY PANEL - 10 Syringe Package

    2022 – 2023 Formula

    10 Single-Dose
    Prefilled Syringes
    0.5 mL each

    Rx only

    4
    STRAINS

    Influenza Vaccine
    Fluzone ®Quadrivalent

    For 6 months of age and older
    For intramuscular injection only

    SANOFI PASTEUR

    PRINCIPAL DISPLAY PANEL - 10 Syringe Package - 49281-422-50

  • INGREDIENTS AND APPEARANCE
    FLUZONE QUADRIVALENT NORTHERN HEMISPHERE 
    influenza a virus a/victoria/2570/2019 ivr-215 (h1n1) antigen (formaldehyde inactivated), influenza a virus a/darwin/9/2021 san-010 (h3n2) antigen (formaldehyde inactivated), influenza b virus b/phuket/3073/2013 antigen (formaldehyde inactivated), and influenza b virus b/michigan/01/2021 antigen (formaldehyde inactivated) injection, suspension
    Product Information
    Product TypeVACCINEItem Code (Source)NDC:83703-044
    Route of AdministrationINTRAMUSCULAR
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: WD5E5VYM2E) (INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:ERB9SJ9VMQ) INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)15 ug  in 0.5 mL
    INFLUENZA A VIRUS A/DARWIN/9/2021 SAN-010 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: KJA387FHB2) (INFLUENZA A VIRUS A/DARWIN/9/2021 SAN-010 (H3N2) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:6S4Y8A8UEY) INFLUENZA A VIRUS A/DARWIN/9/2021 SAN-010 (H3N2) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)15 ug  in 0.5 mL
    INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: B93BQX9789) (INFLUENZA B VIRUS B/PHUKET/3073/2013 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:9HB0XUS9TM) INFLUENZA B VIRUS B/PHUKET/3073/2013 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)15 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)15 ug  in 0.5 mL
    Inactive Ingredients
    Ingredient NameStrength
    OCTOXYNOL-9 (UNII: 7JPC6Y25QS)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)  
    WATER (UNII: 059QF0KO0R)  
    FORMALDEHYDE (UNII: 1HG84L3525)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83703-044-5010 in 1 PACKAGE
    1NDC:83703-044-880.5 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
    BLABLA10391407/01/2022
    Labeler - Bamboo US BidCo LLC (119087615)
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