FDA Orange Book
Generic for Tranxene
Tranxene contains clorazepate. 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 Tranxene is clorazepate. 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 6 Tranxene products the Orange Book lists.
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Tranxene products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 15MG | Discontinued | None | 0 | None |
| capsule, oral | 3.75MG | Discontinued | None | 0 | None |
| capsule, oral | 7.5MG | Discontinued | None | 0 | None |
| tablet, oral | 15MG | Discontinued | None | 4 | AB |
| tablet, oral | 3.75MG | Discontinued | None | 4 | AB |
| tablet, oral | 7.5MG | Marketed (Rx) | AB | 4 | AB |
NDA 017105, held by AJENAT PHARMACEUTICALS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic clorazepate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| AUROBINDO PHARMA LTD | 071858 | AB (A-rated, therapeutically equivalent) | July 17, 1987 | 15MG, 3.75MG, 7.5MG |
| TARO PHARMACEUTICAL INDUSTRIES LTD | 075731 | AB (A-rated, therapeutically equivalent) | April 27, 2000 | 15MG, 3.75MG, 7.5MG |
| MACLEODS PHARMACEUTICALS LTD | 215566 | AB (A-rated, therapeutically equivalent) | June 14, 2022 | 15MG, 3.75MG, 7.5MG |
| NOVITIUM PHARMA LLC | 213730 | AB (A-rated, therapeutically equivalent) | December 16, 2022 | 15MG, 3.75MG, 7.5MG |
Questions
Is there a generic for Tranxene?
Yes. The generic name for Tranxene is clorazepate. 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 6 Tranxene products the Orange Book lists.
What is the generic name for Tranxene?
The active ingredient in Tranxene is clorazepate, 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.