Medicine
Lysodren 500 mg tablet
Lysodren 500 mg tablet is a prescription medicine containing Mitotane for oral use, marketed by Esteve Pharmaceuticals, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store bottles at 25°C (77°F), excursions permitted between 15°C and 30°C…
Key facts
- Active ingredient (INN)
- Mitotane
- Brand
- Lysodren
- Strength
- 500 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 1 bottle
- Marketing authorisation holder
- Esteve Pharmaceuticals
- Manufacturers
- Esteve PharmaceuticalsHRA Pharma Rare Diseases
- Origin register
- US FDA, United States
- Storage
- Store bottles at 25°C (77°F), excursions permitted between 15°C and 30°C (59°F-86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L01XX23 Mitotane
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 15 October 1978
- Identifiers
- RxCUI 197988, 207373DailyMed set ID 4046a224-8832-daa2-e063-6294a90a11d7, f0cd76e9-460c-450e-b094-172e636f340aNDC 68118-080, 76336-080Application NDA016885
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 bottle in 1 carton / 100 tablet in 1 bottle | 68118-080-60 | Esteve Pharmaceuticals | 15 October 1978 |
| 1 bottle in 1 carton / 100 tablet in 1 bottle | 76336-080-60 | HRA Pharma Rare Diseases | 15 October 1978 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Clinical summary
Mitotane is a prescription medicine indicated for the treatment of patients with inoperable, functional or nonfunctional, adrenocortical carcinoma (ACC). It is available as tablets for oral use. MedsAcross supplies Mitotane for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about MitotaneFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Lysodren prescribing information (Esteve Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Lysodren: European public assessment report (EPAR) · European Medicines Agency
Need Lysodren 500 mg tablet for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.