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United States · US · US:52856-601_82f12b65-d2a0-450a-9f11-49ce8aad2e27

KEBILIDI

UNIISPLATC A16AB26

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

Identification

ManufacturerPTC Therapeutics, Inc.
CountryUS (United States)
ATC codeA16AB26
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5285660101
    1 VIAL, GLASS in 1 CARTON (52856-601-01) / .5 mL in 1 VIAL, GLASS (52856-601-11)

Annotations

UNII (FDA Substance ID)
S51J6N56M7
ELADOCAGENE EXUPARVOVEC
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "S51J6N56M7",
    "rxcui": null,
    "inchikey": null,
    "display_name": "ELADOCAGENE EXUPARVOVEC",
    "substance_type": "structurallyDiverse",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRACEREBRAL",
  "spl_meta": {
    "9d6a6401-c6b5-4f29-af11-67707d249482": {
      "match": "brand_token",
      "title": "KEBILIDI (ELADOCAGENE EXUPARVOVEC-TNEQ) SUSPENSION [PTC THERAPEUTICS, INC.]",
      "spl_version": "3",
      "published_date": "2026-01-28"
    }
  },
  "productid": "52856-601_82f12b65-d2a0-450a-9f11-49ce8aad2e27",
  "productndc": "52856-601",
  "dosage_form": "SUSPENSION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ELADOCAGENE EXUPARVOVEC",
  "proprietary_name": "KEBILIDI",
  "active_ingred_unit": "{GC}/mL",
  "application_number": "BLA125722",
  "marketing_category": "BLA",
  "nonproprietary_name": "eladocagene exuparvovec-tneq",
  "start_marketing_date": "20241113",
  "active_numerator_strength": "560000000000"
}

Related drugs

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