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United States · US · US:50090-1645_608f8399-db16-4921-b0c8-153b81b1d568

TWINRIX

UNIISPL

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

Identification

ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5009016450
    10 SYRINGE in 1 CARTON (50090-1645-0) / 1 mL in 1 SYRINGE (50090-1645-9)

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": "50090-1645_608f8399-db16-4921-b0c8-153b81b1d568",
  "productndc": "50090-1645",
  "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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