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United States· US:83703-048_49dccf66-c7fd-0ce9-e063-6394a90a3cf1

HEPLISAV-B

A medicinal product containing hepatitis b vaccine (recombinant) adjuvanted, registered in United States by Bamboo US BidCo LLC.

US label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedHEPLISAV-BATC—REGISTER NO.US:83703-048_49dccf66…PACKS LISTED1CHECKEDJune 3, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about hepatitis b vaccine (recombinant) adjuvantedAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
Hepatitis B Vaccine (Recombinant) Adjuvanted
Manufacturer
Bamboo US BidCo LLC
Country
United States (US)
ATC code
—
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
June 3, 2026

Packs & prices · 1

  • ndc11
    8370304805
    5 SYRINGE in 1 CARTON (83703-048-05) / .5 mL in 1 SYRINGE (83703-048-01)

Regulatory notes

UNII (FDA substance ID)
XL4HLC6JH6
HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN
DailyMed SPL labels
1 version tracked

Same medicine, other countries

Hepatitis b vaccine (recombinant) adjuvanted in 11 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All hepatitis b vaccine (recombinant) adjuvanted products

Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.

For developers

The same record over the API, and the raw payload
GET /v1/drugs/7b8b6145-7abb-4267-9c03-e83ce98a3e05
GET /v1/drugs/7b8b6145-7abb-4267-9c03-e83ce98a3e05?format=fhir

Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.

{
  "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": "83703-048_49dccf66-c7fd-0ce9-e063-6394a90a3cf1",
  "productndc": "83703-048",
  "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"
}
API referenceMCP serverPlans

See everything about hepatitis b vaccine (recombinant) adjuvanted.

This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.

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