FDA Orange Book
Generic for Serax
Serax contains oxazepam. 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 Serax is oxazepam. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 3 of the 4 Serax products the Orange Book lists.
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Serax products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 10MG | Discontinued | None | 4 | AB |
| capsule, oral | 15MG | Discontinued | None | 4 | AB |
| capsule, oral | 30MG | Discontinued | None | 4 | AB |
| tablet, oral | 15MG | Discontinued | None | 0 | None |
NDA 015539, held by ALPHARMA US PHARMACEUTICALS DIVISION. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic oxazepam
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| TP ANDA HOLDINGS LLC | 071026 | AB (A-rated, therapeutically equivalent) | August 10, 1987 | 10MG, 15MG, 30MG |
| ACTAVIS ELIZABETH LLC | 072253 | AB (A-rated, therapeutically equivalent) | April 14, 1988 | 10MG, 15MG, 30MG |
| EPIC PHARMA LLC | 071756 | AB (A-rated, therapeutically equivalent) | April 19, 1988 | 10MG, 15MG, 30MG |
| LEADING PHARMA LLC | 218261 | AB (A-rated, therapeutically equivalent) | March 3, 2025 | 10MG, 15MG, 30MG |
Questions
Is there a generic for Serax?
Yes. The generic name for Serax is oxazepam. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 3 of the 4 Serax products the Orange Book lists.
What is the generic name for Serax?
The active ingredient in Serax is oxazepam, 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.