RECOMBIVAX HB

UNIISPL

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

Identification

ManufacturerBamboo US BidCo LLC

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
8370308502
.5 mL in 1 SYRINGE (83703-085-02)

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; SUBCUTANEOUS",
  "spl_meta": {
    "4c4c3b6a-0522-51a3-e063-6394a90ac5ed": {
      "match": "brand_token",
      "title": "RECOMBIVAX HB (HEPATITIS B VACCINE (RECOMBINANT)) INJECTION, SUSPENSION [BAMBOO US BIDCO LLC]",
      "spl_version": "1",
      "published_date": "2026-05-21"
    }
  },
  "productid": "83703-085_4c4c32a1-19c6-7646-e063-6294a90a431e",
  "productndc": "83703-085",
  "dosage_form": "INJECTION, SUSPENSION",
  "dea_schedule": null,
  "product_type": "VACCINE",
  "substance_name": "HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN",
  "proprietary_name": "RECOMBIVAX HB",
  "active_ingred_unit": "ug/.5mL",
  "application_number": "BLA101066",
  "marketing_category": "BLA",
  "nonproprietary_name": "Hepatitis B Vaccine (Recombinant)",
  "start_marketing_date": "20260226",
  "active_numerator_strength": "5"
}

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