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United States · US · US:58160-815_f99d8a1b-e81c-4ccc-9a97-b47dc52039ad

TWINRIX

UNIISPL

Last synced from FDA National Drug Code directory (United States) on

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
    5816081552
    10 SYRINGE in 1 CARTON (58160-815-52) / 1 mL in 1 SYRINGE (58160-815-43)

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": {
    "18e8f9fc-4d62-4d30-4ab7-bac03336171e": {
      "match": "brand_token",
      "title": "TWINRIX (HEPATITIS A AND HEPATITIS B (RECOMBINANT) VACCINE) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]",
      "spl_version": "34",
      "published_date": "2026-05-27"
    }
  },
  "productid": "58160-815_f99d8a1b-e81c-4ccc-9a97-b47dc52039ad",
  "productndc": "58160-815",
  "dosage_form": "INJECTION, SUSPENSION",
  "dea_schedule": null,
  "product_type": "VACCINE",
  "substance_name": "HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED); HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN",
  "proprietary_name": "TWINRIX",
  "active_ingred_unit": "[iU]/mL; ug/mL",
  "application_number": "BLA103850",
  "marketing_category": "BLA",
  "nonproprietary_name": "Hepatitis A and Hepatitis B (Recombinant) Vaccine",
  "start_marketing_date": "20070607",
  "active_numerator_strength": "720; 20"
}

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