FDA Orange Book
Generic for Xenazine
Xenazine contains tetrabenazine. 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 Xenazine is tetrabenazine. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Xenazine products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 12.5MG | Marketed (Rx) | AB | 7 | AB |
| tablet, oral | 25MG | Marketed (Rx) | AB | 8 | AB |
NDA 021894, held by BAUSCH HEALTH US LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic tetrabenazine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| HETERO LABS LTD UNIT V | 204574 | AB (A-rated, therapeutically equivalent) | February 3, 2016 | 12.5MG, 25MG |
| MYLAN PHARMACEUTICALS INC | 207682 | AB (A-rated, therapeutically equivalent) | January 31, 2017 | 12.5MG, 25MG |
| ACTAVIS LABORATORIES FL INC | 206686 | AB (A-rated, therapeutically equivalent) | July 7, 2017 | 25MG |
| BIONPHARMA INC | 208826 | AB (A-rated, therapeutically equivalent) | December 18, 2017 | 12.5MG, 25MG |
| DR REDDYS LABORATORIES LTD | 209284 | AB (A-rated, therapeutically equivalent) | January 8, 2018 | 12.5MG, 25MG |
| CHARTWELL RX SCIENCES LLC | 210544 | AB (A-rated, therapeutically equivalent) | April 20, 2018 | 12.5MG, 25MG |
| PIRAMAL HEALTHCARE UK LTD | 213316 | AB (A-rated, therapeutically equivalent) | January 22, 2020 | 12.5MG, 25MG |
| APOTEX INC | 206093 | AB (A-rated, therapeutically equivalent) | March 17, 2020 | 12.5MG, 25MG |
Xenazine NDC codes
Questions
Is there a generic for Xenazine?
Yes. The generic name for Xenazine is tetrabenazine. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Xenazine?
The active ingredient in Xenazine is tetrabenazine, 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.