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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
- ndc1183222020011 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.
- ISLibmeldyOrchard Therapeutics (Netherlands) B.V.
- PLLibmeldyOrchard Therapeutics (Netherlands) BV
- DKLibmeldyOrchard Therapeutics BV
- FILibmeldyOrchard Therapeutics (Netherlands) BV
- CZLIBMELDYOrchard Therapeutics (Netherlands) B.V., Leiden
- BELibmeldy 2 10*6 cells/ml - 10 10*6 cells/mlOrchard Therapeutics (Netherlands)
- 🇫🇷LIBMELDY 2-10 x 1 000 000 cellules / ml, dispersion pour perfusionORCHARD THERAPEUTICS (NETHERLANDS) (PAYS-BAS)
- 🇪🇸LIBMELDY 2-10 X 10^6 CELULAS/ML DISPERSION PARA PERFUSIONOrchard Therapeutics (Netherlands) B.V.
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