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United States · US · US:73554-2111_1204fe44-ece9-4967-a7df-f005e166ac75

Skysona

UNIISPLATC A16AX21

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

Identification

ManufacturerGenetix Biotherapeutics Inc.
CountryUS (United States)
ATC codeA16AX21
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7355421111
    1 SUSPENSION in 1 BAG (73554-2111-1)

Annotations

UNII (FDA Substance ID)
KUM75TD6SG
ELIVALDOGENE AUTOTEMCEL
RxCUI 2612527
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "KUM75TD6SG",
    "rxcui": "2612527",
    "inchikey": null,
    "display_name": "ELIVALDOGENE AUTOTEMCEL",
    "substance_type": "structurallyDiverse",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "f189502b-dc44-4289-99a6-cfba36918329": {
      "match": "brand_token",
      "title": "SKYSONA (ELIVALDOGENE AUTOTEMCEL) SUSPENSION [GENETIX BIOTHERAPEUTICS INC.]",
      "spl_version": "12",
      "published_date": "2026-04-14"
    }
  },
  "productid": "73554-2111_1204fe44-ece9-4967-a7df-f005e166ac75",
  "productndc": "73554-2111",
  "dosage_form": "SUSPENSION",
  "dea_schedule": null,
  "product_type": "CELLULAR THERAPY",
  "substance_name": "ELIVALDOGENE AUTOTEMCEL",
  "proprietary_name": "Skysona",
  "active_ingred_unit": "1/1",
  "application_number": "BLA125755",
  "marketing_category": "BLA",
  "nonproprietary_name": "elivaldogene autotemcel",
  "start_marketing_date": "20220916",
  "active_numerator_strength": "30000000"
}

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