Label: FLUCELVAX QUADRIVALENT (influenza a virus a/georgia/12/2022 cvr-167 (h1n1) antigen (mdck cell derived, propiolactone inactivated), influenza a virus a/darwin/11/2021 (h3n2) antigen (mdck cell derived, propiolactone inactivated),influenza b virus b/singapore/wuh4618/2021 antigen (mdck cell derived, propiolactone inactivated),influenza b virus b/singapore/inftt-16-0610/2016 antigen- mdck cell derived, propiolactone inactivated injection, suspension

  • NDC Code(s): 83703-037-03, 83703-037-04
  • Packager: Bamboo US BidCo LLC
  • Category: VACCINE LABEL
  • DEA Schedule: None
  • Marketing Status: Biologic Licensing Application

Drug Label Information

Updated June 17, 2024

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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 Injection Only

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

    Rx Only

    Influenza Vaccine

    FLUCELVAX®

    QUADRIVALENT

    2023 – 2024 Formula

    Seqirus™

    Principal Display Panel – 0.5 mL Carton Label

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel – 0.5 mL Syringe Label

    Influenza Vaccine

    FLUCELVAX®

    QUADRIVALENT

    2023 - 2024 Formula

    0.5 mL dose

    Rx Only

    FOR IM USE ONLY

    Principal Display Panel – 0.5 mL Syringe Label
  • INGREDIENTS AND APPEARANCE
    FLUCELVAX QUADRIVALENT 
    influenza a virus a/georgia/12/2022 cvr-167 (h1n1) antigen (mdck cell derived, propiolactone inactivated), influenza a virus a/darwin/11/2021 (h3n2) antigen (mdck cell derived, propiolactone inactivated),influenza b virus b/singapore/wuh4618/2021 antigen (mdck cell derived, propiolactone inactivated),influenza b virus b/singapore/inftt-16-0610/2016 antigen (mdck cell derived, propiolactone inactivated) injection, suspension
    Product Information
    Product TypeVACCINEItem Code (Source)NDC:83703-037
    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/DARWIN/11/2021 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) (UNII: PV9K2R8HRM) (INFLUENZA A VIRUS A/DARWIN/11/2021 (H3N2) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) - UNII:C6PM4NXJ33) INFLUENZA A VIRUS A/DARWIN/11/2021 (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
    INFLUENZA B VIRUS B/SINGAPORE/INFTT-16-0610/2016 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) (UNII: G4VX46P9M6) (INFLUENZA B VIRUS B/SINGAPORE/INFTT-16-0610/2016 HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) - UNII:0JXM8X6ZW8) INFLUENZA B VIRUS B/SINGAPORE/INFTT-16-0610/2016 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:83703-037-0310 in 1 CARTON
    1NDC:83703-037-040.5 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
    BLABLA12540807/01/202307/31/2024
    Labeler - Bamboo US BidCo LLC (119087615)
    Establishment
    NameAddressID/FEIBusiness Operations
    Seqirus Inc.080102141manufacture, label, pack, analysis
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