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

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.

ATC A16AB21US label

Checked against FDA National Drug Code directory (United States) on June 3, 2026

Informational only — not a medical device.

Compare price across countriesPer daily dose · free account Ask the assistant about atidarsagene autotemcelAnswers with sources · free account Check interactionsSeverity free · mechanism on Growth

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

Search atidarsagene autotemcel products by name

Atidarsagene autotemcel · ATC A16AB21

9 / 19 countries

Belgiumprice
Czechiaprice
Denmark
Finlandprice
Icelandprice
Ireland
Polandprice
United Kingdom
United Statesprice

Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

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: June 3, 2026

Packs & prices · 1

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

Regulatory notes

UNII (FDA substance ID)

EPP8G99QG4

ATIDARSAGENE AUTOTEMCEL

DailyMed SPL labels

1 version tracked

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.

All atidarsagene autotemcel products

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/e705d627-4943-440f-a7e2-fe6d6d24d720
GET /v1/drugs/e705d627-4943-440f-a7e2-fe6d6d24d720?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.

{
  "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"
}

API reference MCP server Plans

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.

Try it free Open in the console