United States· US:83222-0200_5474a8af-7dd9-3e6a-e063-6294a90a8de2
LENMELDY
A atidarsagene autotemcel product containing atidarsagene autotemcel, registered in United States by Orchard Therapeutics (Europe) Ltd. The same ATC class is registered in 9 of our 19 countries.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
Where it is registered
Atidarsagene autotemcel is registered in 9 of 19 countries.
Countries holding a registration under ATC A16AB21 (atidarsagene autotemcel), each read from that country’s own register.
- This record: United States, from FDA National Drug Code directory (United States)
- 6 of them publish a price we can compare per daily dose
Atidarsagene autotemcel · ATC A16AB21
9 / 19 countries
- Belgiumprice
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Ireland
- Polandprice
- United Kingdom
- United Statesprice
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- ATIDARSAGENE AUTOTEMCEL
- Manufacturer
- Orchard Therapeutics (Europe) Ltd
- Country
- United States (US)
- ATC code
- A16AB21
- ATC class
- Atidarsagene autotemcel
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 1
- ndc1183222-0200-1
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Atidarsagene autotemcel in 11 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- IcelandLibmeldyOrchard Therapeutics (Netherlands) B.V.
- BelgiumLibmeldy 2 10*6 cells/ml - 10 10*6 cells/mlOrchard Therapeutics (Netherlands)
- SpainLIBMELDY 2-10 X 10^6 CELULAS/ML DISPERSION PARA PERFUSIONOrchard Therapeutics (Netherlands) B.V.
- FinlandLibmeldyOrchard Therapeutics (Netherlands) BV
- FranceLIBMELDY 2-10 x 1 000 000 cellules / ml, dispersion pour perfusionORCHARD THERAPEUTICS (NETHERLANDS) (PAYS-BAS)
- United KingdomLibmeldy 2million-10million cells/ml dispersion for infusion bagsOrchard Therapeutics (Europe) Ltd
- IrelandLibmeldy 2-10 x 106 cells/mL dispersion for infusionOrchard Therapeutics (Netherlands) B.V.
- NetherlandsLibmeldy 2-10 x 10^6 cellen/ml dispersie voor infusieOrchard Therapeutics (Netherlands) B.V.
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Libmeldy, Strimvelis
- Liechtenstein · Libmeldy, Strimvelis
- Norway · Libmeldy, Strimvelis
Source: European Medicines Agency, Article 57 product data.
Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.
For developers
The same record over the API, and the raw payload
GET /v1/drugs/80c97718-4ccf-4a97-a54f-c18287a80349 GET /v1/drugs/80c97718-4ccf-4a97-a54f-c18287a80349?format=fhir
Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.
{
"route": "INTRAVENOUS",
"source": "ndc",
"strength": "11800000",
"substance": "ATIDARSAGENE AUTOTEMCEL",
"productndc": "83222-0200",
"dosage_form": "SUSPENSION",
"dea_schedule": null,
"strength_unit": "1/1",
"application_number": "BLA125758",
"marketing_category": "BLA"
}See everything about atidarsagene autotemcel.
This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.