HEPLISAV-B

UNIISPL

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerDynavax Technologies Corporation

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4352800305
5 SYRINGE in 1 CARTON (43528-003-05) / .5 mL in 1 SYRINGE (43528-003-01)

Annotations

UNII (FDA Substance ID)

XL4HLC6JH6

HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "XL4HLC6JH6",
    "rxcui": null,
    "inchikey": null,
    "display_name": "HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN",
    "substance_type": "structurallyDiverse",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR",
  "spl_meta": {
    "1a8b8271-208d-ecde-e063-6294a90a54c6": {
      "match": "brand_token",
      "title": "HEPLISAV-B (HEPATITIS B VACCINE (RECOMBINANT) ADJUVANTED) INJECTION, SOLUTION [BAMBOO US BIDCO LLC]",
      "spl_version": "5",
      "published_date": "2026-05-21"
    }
  },
  "productid": "43528-003_4b308f87-c35b-9d96-e063-6294a90aff8e",
  "productndc": "43528-003",
  "dosage_form": "INJECTION, SOLUTION",
  "dea_schedule": null,
  "product_type": "VACCINE",
  "substance_name": "HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN",
  "proprietary_name": "HEPLISAV-B",
  "active_ingred_unit": "ug/.5mL",
  "application_number": "BLA125428",
  "marketing_category": "BLA",
  "nonproprietary_name": "Hepatitis B Vaccine (Recombinant) Adjuvanted",
  "start_marketing_date": "20180101",
  "active_numerator_strength": "20"
}

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