Drug
Who makes mitotane?
2 companies list mitotane as a human prescription drug, including under the names Lysodren. Forms: tablet. Routes: oral.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing mitotane
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| ESTEVE PHARMACEUTICALS, S.A. | tablet | NDANDA016885 | 1 | 0 |
| HRA Pharma Rare Diseases | tablet | NDANDA016885 | 1 | 0 |
Bulk ingredient listings
- Darmerica, LLCUnited States · 1 NDC
- ISP Chemicals LLCUnited States · 1 NDC
- MEDISCA Inc.United States · 1 NDC
Enquiry
Common questions
- Who makes mitotane?
- 2 companies list mitotane as a human prescription drug in the openFDA NDC Directory, led by ESTEVE PHARMACEUTICALS, S.A., HRA Pharma Rare Diseases. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Who supplies mitotane active ingredient?
- 3 companies list mitotane as a bulk ingredient, including Darmerica, LLC, ISP Chemicals LLC, MEDISCA Inc..