Label: HEPLISAV-B (hepatitis b vaccine- recombinant adjuvanted injection, solution

  • NDC Code(s): 83703-048-01, 83703-048-05
  • 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 Panel - Carton - Vials

    Rx only

    Hepatitis B Vaccine
    (Recombinant),
    Adjuvanted

    HEPLISAV-B ™

    5 x 0.5 mL
    single-dose vials

    For intramuscular
    administration only

    DYNAVAX

    Image of Carton of Vials- Principal Panel
  • PRINCIPAL DISPLAY PANEL

    Principal Panel - Carton - Prefilled Syringes

    Rx only

    Hepatitis B Vaccine
    (Recombinant),
    Adjuvanted

    HEPLISAV-B ®

    5 x 0.5 mL single-dose syringes

    For intramuscular
    administration only

    For Adult Use Only

    NEEDLES NOT INCLUDED

    DYNAVAX

    Image of Carton of Syringes- Principal Panel

  • PRINCIPAL DISPLAY PANEL

    Principal Panel - Label - Prefilled Syringes

    HEPLISAV-B ®

    1 dose (0.5 mL)

    Hepatitis B Vaccine
    (Recombinant), Adjuvanted

    For IM use only DO NOT FREEZE
    Store at 2-8°C (36-46°F)
    Mfd. by Dynavax Tech. Corp.

    Image of Label for PRefilled Syringes - Principal Panel
  • INGREDIENTS AND APPEARANCE
    HEPLISAV-B 
    hepatitis b vaccine (recombinant) adjuvanted injection, solution
    Product Information
    Product TypeVACCINEItem Code (Source)NDC:83703-048
    Route of AdministrationINTRAMUSCULAR
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN (UNII: XL4HLC6JH6) (HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN - UNII:XL4HLC6JH6) HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN20 ug  in 0.5 mL
    Inactive Ingredients
    Ingredient NameStrength
    1018 ISS (UNII: 25DT549L0G)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE (UNII: E1W4N241FO)  
    SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83703-048-055 in 1 CARTON
    1NDC:83703-048-010.5 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12542801/01/2018
    Labeler - Bamboo US BidCo LLC (119087615)
    Registrant - Dynavax Technologies Corporation (964173801)
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