RECOMBIVAX HB

UNIISPL

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

Identification

ManufacturerMerck Sharp & Dohme LLC

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0006409402
10 SYRINGE in 1 CARTON (0006-4094-02) / 1 mL in 1 SYRINGE (0006-4094-01)

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; 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": "0006-4094_32dbed7b-c62b-4294-8476-d134c8c1a6f4",
  "productndc": "0006-4094",
  "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/mL",
  "application_number": "BLA101066",
  "marketing_category": "BLA",
  "nonproprietary_name": "Hepatitis B Vaccine (Recombinant)",
  "start_marketing_date": "19860723",
  "active_numerator_strength": "10"
}

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