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United States· US:68118-080_58257b74-15bb-d5d5-e063-6394a90accc7

Lysodren

A mitotane product containing mitotane, registered in United States by ESTEVE PHARMACEUTICALS, S.A.. The same ATC class is registered in 15 of our 19 countries.

ATC L01XX23

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

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedLysodrenATCL01XX23REGISTER NO.US:68118-080_58257b74…PACKS LISTED1CHECKEDSeptember 27, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about mitotaneAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Mitotane is registered in 15 of 19 countries.

Countries holding a registration under ATC L01XX23 (mitotane), each read from that country’s own register.

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

Mitotane · ATC L01XX23

15 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Franceprice
  • Icelandprice
  • Ireland
  • Italyprice
  • Netherlands
  • Norwayprice
  • Polandprice
  • Switzerlandprice
  • 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
MITOTANE
Manufacturer
ESTEVE PHARMACEUTICALS, S.A.
Country
United States (US)
ATC code
L01XX23
ATC class
Mitotane
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 27, 2026

Packs & prices · 1

  • ndc11
    68118-080-60

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Interactions

376 interactions on record for mitotane.

Graded by severity as the source publishes them — 193 severe. Severity grades are free for everyone; mechanism and management come with Growth.

  • Severity for every pair — free, no plan needed
  • The source, licence and sync date on every record
  • Mechanism and what to do for each pair — Growth plan
Check mitotane against other medicinesHow interaction checks work

Mitotane · interactions on record

376 records

  • 193 severe
  • 138 moderate
  • 30 minor
  • 15 info

Most severe, free to view

  • RolapitantA04AD14severe
  • NaloxegolA06AH03severe
  • NaldemedineA06AH05severe
  • EliglustatA16AX10severe
  • Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
Mechanism and what to do, in the interaction check
Source: DDInter 2.0 · synced 29 Sept 2026. Grades as the source publishes them.

Same medicine, other countries

Mitotane in 16 other countries

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

All mitotane products

Authorised across Europe · EMA

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

  • Iceland · Lysodren
  • Liechtenstein · Lysodren
  • Norway · Lysodren

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/b262c13d-46ba-4798-96f7-710bb8d1a93c
GET /v1/drugs/b262c13d-46ba-4798-96f7-710bb8d1a93c?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": "ORAL",
  "source": "ndc",
  "strength": "500",
  "substance": "MITOTANE",
  "productndc": "68118-080",
  "dosage_form": "TABLET",
  "dea_schedule": null,
  "strength_unit": "mg/1",
  "application_number": "NDA016885",
  "marketing_category": "NDA"
}
API referenceMCP serverPlans

See everything about mitotane.

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 freeOpen in the console