FDA Orange Book
Generic for Serzone
Serzone contains nefazodone. 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 Serzone is nefazodone. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Generics match 5 of the 6 Serzone products the Orange Book lists.
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Serzone products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 100MG | Discontinued | None | 1 | None |
| tablet, oral | 150MG | Discontinued | None | 1 | None |
| tablet, oral | 200MG | Discontinued | None | 1 | None |
| tablet, oral | 250MG | Discontinued | None | 1 | None |
| tablet, oral | 300MG | Discontinued | None | 0 | None |
| tablet, oral | 50MG | Discontinued | None | 1 | None |
NDA 020152, held by BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic nefazodone
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| TEVA PHARMACEUTICALS USA INC | 076037 | None (No TE code listed) | September 16, 2003 | 100MG, 150MG, 200MG, 250MG, 50MG |
Questions
Is there a generic for Serzone?
Yes. The generic name for Serzone is nefazodone. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Generics match 5 of the 6 Serzone products the Orange Book lists.
What is the generic name for Serzone?
The active ingredient in Serzone is nefazodone, 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.