HEPLISAV-B

UNIISPL

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

Identification

ManufacturerA-S Medication Solutions

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5009045260
5 SYRINGE in 1 CARTON (50090-4526-0) / .5 mL in 1 SYRINGE (50090-4526-1)

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": "50090-4526_bc19aced-d2fa-4b4f-8824-e15a56fe422d",
  "productndc": "50090-4526",
  "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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