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United States· US:82448-260_849abb0f-1b19-4b4f-a3fe-113869a59653

Gomekli

A mirdametinib product containing mirdametinib, registered in United States by SpringWorks Therapeutics, Inc.. The same ATC class is registered in 11 of our 19 countries.

ATC L01EE05Orange BookUS label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedGomekliATCL01EE05REGISTER NO.US:82448-260_849abb0f…PACKS LISTED2CHECKEDSeptember 12, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about mirdametinibAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Mirdametinib is registered in 11 of 19 countries.

Countries holding a registration under ATC L01EE05 (mirdametinib), each read from that country’s own register.

  • This record: United States, from FDA National Drug Code directory (United States)
  • 9 of them publish a price we can compare per daily dose
Search mirdametinib products by name

Mirdametinib · ATC L01EE05

11 / 19 countries

  • Belgiumprice
  • Czechiaprice
  • Finlandprice
  • Franceprice
  • Icelandprice
  • Ireland
  • Netherlands
  • Norwayprice
  • Spainprice
  • Switzerlandprice
  • 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
mirdametinib
Manufacturer
SpringWorks Therapeutics, Inc.
Country
United States (US)
ATC code
L01EE05
ATC class
Mirdametinib
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 12, 2026

Packs & prices · 2

  • ndc11
    8244826042
    42 CAPSULE in 1 BOTTLE (82448-260-42)
  • ndc11
    8244826084
    84 CAPSULE in 1 BOTTLE (82448-260-84)

Regulatory notes

UNII (FDA substance ID)
86K0J5AK6M
MIRDAMETINIB
Orange Book
N219389
DailyMed SPL labels
1 version tracked

Same medicine, other countries

Mirdametinib in 12 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All mirdametinib products

Authorised across Europe · EMA

The same active substance is authorised in 3 EEA countries. Names it is sold under:

  • Iceland · Ezmekly
  • Liechtenstein · Ezmekly
  • Norway · Ezmekly

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/e5cebfef-f355-47ae-b33b-3b4fa7315b8f
GET /v1/drugs/e5cebfef-f355-47ae-b33b-3b4fa7315b8f?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": "86K0J5AK6M",
    "rxcui": null,
    "inchikey": "SUDAHWBOROXANE-SECBINFHSA-N",
    "display_name": "MIRDAMETINIB",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "livertox": {
    "summary": null,
    "livertox_id": null,
    "hepatotoxicity_score": null
  },
  "spl_meta": {
    "4c41bf90-5fa7-4935-a95c-e047ea6bbf8e": {
      "match": "brand_token",
      "title": "GOMEKLI (MIRDAMETINIB) CAPSULE GOMEKLI (MIRDAMETINIB) TABLET, FOR SUSPENSION [SPRINGWORKS THERAPEUTICS, INC.]",
      "spl_version": "6",
      "published_date": "2026-05-15"
    }
  },
  "productid": "82448-260_849abb0f-1b19-4b4f-a3fe-113869a59653",
  "productndc": "82448-260",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "219389",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "1MG",
        "product_no": "001",
        "approval_date": "Feb 11, 2025"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "2MG",
        "product_no": "002",
        "approval_date": "Feb 11, 2025"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MIRDAMETINIB",
  "proprietary_name": "Gomekli",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA219389",
  "marketing_category": "NDA",
  "nonproprietary_name": "mirdametinib",
  "start_marketing_date": "20250211",
  "active_numerator_strength": "2"
}
API referenceMCP serverPlans

See everything about mirdametinib.

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.

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