Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| ISP Chemicals LLC | Columbus, OH, United States | Makes the active ingredient | Problems found, fixed voluntarilyJan 29, 2024 · 5 inspections |
| Latina Pharma S.P.A | Sermoneta, Italy | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyJan 19, 2024 · 5 inspections, 1 with FDA action |
Product details
- Generic drug
- Mitotane: every company that makes it
- Form
- tablet, oral
- Strength
- 500 mg
- Approval
- NDA NDA016885
- On the market since
- Oct 15, 1978
- Package NDCs
76336-080-60- Official label
- DailyMed (National Library of Medicine), updated Oct 8, 2025
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