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United States · US · US:83222-0200_3c2e8ac2-b01d-d709-e063-6294a90a24da

LENMELDY

UNIISPLATC A16AB21

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

Identification

ManufacturerOrchard Therapeutics (Europe) Ltd
CountryUS (United States)
ATC codeA16AB21
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    8322202001
    1 SUSPENSION in 1 BAG (83222-0200-1)

Annotations

UNII (FDA Substance ID)
EPP8G99QG4
ATIDARSAGENE AUTOTEMCEL
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "EPP8G99QG4",
    "rxcui": null,
    "inchikey": null,
    "display_name": "ATIDARSAGENE AUTOTEMCEL",
    "substance_type": "structurallyDiverse",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "b3e307a7-561b-43b6-a784-9cb1dcfc5196": {
      "match": "brand_token",
      "title": "LENMELDY (ATIDARSAGENE AUTOTEMCEL) SUSPENSION [ORCHARD THERAPEUTICS (EUROPE) LTD]",
      "spl_version": "7",
      "published_date": "2025-08-14"
    }
  },
  "productid": "83222-0200_3c2e8ac2-b01d-d709-e063-6294a90a24da",
  "productndc": "83222-0200",
  "dosage_form": "SUSPENSION",
  "dea_schedule": null,
  "product_type": "CELLULAR THERAPY",
  "substance_name": "ATIDARSAGENE AUTOTEMCEL",
  "proprietary_name": "LENMELDY",
  "active_ingred_unit": "1/1",
  "application_number": "BLA125758",
  "marketing_category": "BLA",
  "nonproprietary_name": "atidarsagene autotemcel",
  "start_marketing_date": "20240426",
  "active_numerator_strength": "11800000"
}

Related drugs

Other records sharing ATC code A16AB21.

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