HAVRIX

UNIISPL

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

Identification

ManufacturerGlaxoSmithKline Biologicals SA

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5816082652
10 SYRINGE in 1 CARTON (58160-826-52) / 1 mL in 1 SYRINGE (58160-826-43)

Annotations

UNII (FDA Substance ID)

5BFC8LZ6LQ

HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED)

RxCUI 798361

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "5BFC8LZ6LQ",
    "rxcui": "798361",
    "inchikey": null,
    "display_name": "HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED)",
    "substance_type": "structurallyDiverse",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR",
  "spl_meta": {
    "f9499a4d-1288-4bd3-9d59-1d72092c38cd": {
      "match": "brand_token",
      "title": "HAVRIX (HEPATITIS A VACCINE) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]",
      "spl_version": "33",
      "published_date": "2026-05-27"
    }
  },
  "productid": "58160-826_da1bf14f-4608-4053-ba84-1875481ba838",
  "productndc": "58160-826",
  "dosage_form": "INJECTION, SUSPENSION",
  "dea_schedule": null,
  "product_type": "VACCINE",
  "substance_name": "HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED)",
  "proprietary_name": "HAVRIX",
  "active_ingred_unit": "[iU]/mL",
  "application_number": "BLA103475",
  "marketing_category": "BLA",
  "nonproprietary_name": "Hepatitis A Vaccine",
  "start_marketing_date": "20070413",
  "active_numerator_strength": "1440"
}

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