FLUARIX

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
5816091252
10 SYRINGE in 1 CARTON (58160-912-52) / .5 mL in 1 SYRINGE (58160-912-41)

Annotations

UNII (FDA Substance ID)

6TU4EY6UNW

INFLUENZA A VIRUS A/THAILAND/8/2022 IVR-237 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED)

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "6TU4EY6UNW",
    "rxcui": null,
    "inchikey": null,
    "display_name": "INFLUENZA A VIRUS A/THAILAND/8/2022 IVR-237 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED)",
    "substance_type": "structurallyDiverse",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR",
  "spl_meta": {
    "61d4995d-92be-4678-74b9-79b3e12e5e30": {
      "match": "brand_token",
      "title": "FLUARIX 2025/2026 (INFLUENZA VIRUS VACCINE) SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]",
      "spl_version": "16",
      "published_date": "2026-03-19"
    }
  },
  "productid": "58160-912_924e4aa4-fda4-449f-8427-6c964b661ccc",
  "productndc": "58160-912",
  "dosage_form": "SUSPENSION",
  "dea_schedule": null,
  "product_type": "VACCINE",
  "substance_name": "INFLUENZA A VIRUS A/THAILAND/8/2022 IVR-237 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 BVR-26 ANTIGEN (FORMALDEHYDE INACTIVATED)",
  "proprietary_name": "FLUARIX",
  "active_ingred_unit": "ug/.5mL; ug/.5mL; ug/.5mL",
  "application_number": "BLA125127",
  "marketing_category": "BLA",
  "nonproprietary_name": "influenza virus vaccine",
  "start_marketing_date": "20250701",
  "active_numerator_strength": "15; 15; 15"
}

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