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    NDC 43528-0003-05 HEPLISAV-B 20 ug/.5mL Details

    HEPLISAV-B 20 ug/.5mL

    HEPLISAV-B is a INTRAMUSCULAR INJECTION, SOLUTION in the VACCINE category. It is labeled and distributed by Dynavax Technologies Corporation. The primary component is HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN.

    Product Information

    NDC 43528-0003
    Product ID 43528-003_f698a0e4-1e23-47f3-aee5-2d6c54131e5a
    Associated GPIs 1710001030E520
    GCN Sequence Number 078645
    GCN Sequence Number Description hepatitis B vaccine/CpG1018/PF SYRINGE 20 MCG/0.5 INTRAMUSC
    HIC3 W7B
    HIC3 Description VIRAL/TUMORIGENIC VACCINES
    GCN 45012
    HICL Sequence Number 044645
    HICL Sequence Number Description HEPATITIS B VACCINE RECOMBINANT/VACCINE ADJUVANT CPG 1018/PF
    Brand/Generic Brand
    Proprietary Name HEPLISAV-B
    Proprietary Name Suffix n/a
    Non-Proprietary Name Hepatitis B Vaccine (Recombinant) Adjuvanted
    Product Type VACCINE
    Dosage Form INJECTION, SOLUTION
    Route INTRAMUSCULAR
    Active Ingredient Strength 20
    Active Ingredient Units ug/.5mL
    Substance Name HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN
    Labeler Name Dynavax Technologies Corporation
    Pharmaceutical Class Actively Acquired Immunity [PE], Hepatitis B Vaccines [CS], Inactivated Hepatitis B Virus Vaccine [EPC], Vaccines, Inactivated [CS]
    DEA Schedule n/a
    Marketing Category BLA
    Application Number BLA125428
    Listing Certified Through 2024-12-31

    Package

    NDC 43528-0003-05 (43528000305)

    NDC Package Code 43528-003-05
    Billing NDC 43528000305
    Package 5 SYRINGE in 1 CARTON (43528-003-05) / .5 mL in 1 SYRINGE (43528-003-01)
    Marketing Start Date 2018-01-01
    NDC Exclude Flag N
    Pricing Information N/A