FDA Orange Book
Is there a generic for Lysodren?
Lysodren contains mitotane. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Lysodren (mitotane).
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Lysodren products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 500MG | Marketed (Rx) | None | 0 | None |
NDA 016885, held by ESTEVE PHARMACEUTICALS SA. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Lysodren NDC codes
Questions
Is there a generic for Lysodren?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Lysodren (mitotane).
What is the generic name for Lysodren?
The active ingredient in Lysodren is mitotane, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.