FDA Orange Book
Generic for Mellaril
Mellaril contains thioridazine. 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
Yes. The generic name for Mellaril is thioridazine. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Generics match 4 of the 9 Mellaril products the Orange Book lists.
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Mellaril products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| concentrate, oral | 100MG/ML | Discontinued | None | 0 | None |
| concentrate, oral | 30MG/ML | Discontinued | None | 0 | None |
| tablet, oral | 100MG | Discontinued | None | 1 | None |
| tablet, oral | 10MG | Discontinued | None | 1 | None |
| tablet, oral | 150MG | Discontinued | None | 0 | None |
| tablet, oral | 15MG | Discontinued | None | 0 | None |
| tablet, oral | 200MG | Discontinued | None | 0 | None |
| tablet, oral | 25MG | Discontinued | None | 1 | None |
| tablet, oral | 50MG | Discontinued | None | 1 | None |
NDA 011808, held by NOVARTIS PHARMACEUTICALS CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic thioridazine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| MYLAN PHARMACEUTICALS INC | 088004 | None (No TE code listed) | November 18, 1983 | 100MG, 10MG, 25MG, 50MG |
Questions
Is there a generic for Mellaril?
Yes. The generic name for Mellaril is thioridazine. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Generics match 4 of the 9 Mellaril products the Orange Book lists.
What is the generic name for Mellaril?
The active ingredient in Mellaril is thioridazine, 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.