Label: FLUCELVAX (influenza a virus a/georgia/12/2022 cvr-167 (h1n1) antigen (mdck cell derived, propiolactone inactivated), influenza a virus a/victoria/800/2024 cvr-289 (h3n2) antigen (mdck cell derived, propiolactone inactivated), influenza b virus b/singapore/wuh4618/2021 antigen- mdck cell derived, propiolactone inactivated injection, suspension

  • NDC Code(s): 83703-088-03, 83703-088-04
  • Packager: Bamboo US BidCo LLC
  • Category: VACCINE LABEL
  • DEA Schedule: None
  • Marketing Status: Biologic Licensing Application

Drug Label Information

Updated June 17, 2026

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  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel – 0.5 mL Carton Label

    For use in persons 6 months of age and older

    For Intramuscular Use

    Ten 0.5 mL, single-dose, pre-filled syringes

    Rx Only

    Influenza Vaccine
    FLUCELVAX     ®

    2026 - 2027 FORMULA

    Seqirus™

    5

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel – 0.5 mL Syringe Label

    Influenza Vaccine
    FLUCELVAX     ®

    2026 - 2027 Formula

    0.5 mL dose

    Rx Only

    FOR IM USE

    For 6 months of age
    and older

    6

  • INGREDIENTS AND APPEARANCE
    FLUCELVAX 
    influenza a virus a/georgia/12/2022 cvr-167 (h1n1) antigen (mdck cell derived, propiolactone inactivated), influenza a virus a/victoria/800/2024 cvr-289 (h3n2) antigen (mdck cell derived, propiolactone inactivated), influenza b virus b/singapore/wuh4618/2021 antigen (mdck cell derived, propiolactone inactivated) injection, suspension
    Product Information
    Product TypeVACCINEItem Code (Source)NDC:83703-088
    Route of AdministrationINTRAMUSCULAR
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    INFLUENZA A VIRUS A/GEORGIA/12/2022 CVR-167 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) (UNII: B8P3XN76W4) (INFLUENZA A VIRUS A/GEORGIA/12/2022 CVR-167 (H1N1) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) - UNII:N8JKS3VK2A) INFLUENZA A VIRUS A/GEORGIA/12/2022 CVR-167 (H1N1) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)15 ug  in 0.5 mL
    INFLUENZA A VIRUS A/VICTORIA/800/2024 CVR-289 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) (UNII: 4HH5SUR63T) (INFLUENZA A VIRUS A/VICTORIA/800/2024 CVR-289 (H3N2) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) - UNII:9V9Y969F8M) INFLUENZA A VIRUS A/VICTORIA/800/2024 CVR-289 (H3N2) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)15 ug  in 0.5 mL
    INFLUENZA B VIRUS B/SINGAPORE/WUH4618/2021 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) (UNII: TUE3AGP9ME) (INFLUENZA B VIRUS B/SINGAPORE/WUH4618/2021 HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) - UNII:C76JLA4DM6) INFLUENZA B VIRUS B/SINGAPORE/WUH4618/2021 HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)15 ug  in 0.5 mL
    Inactive Ingredients
    Ingredient NameStrength
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)  
    POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83703-088-0310 in 1 CARTON
    1NDC:83703-088-040.5 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
    BLABLA12540808/01/2026
    Labeler - Bamboo US BidCo LLC (119087615)
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