Active substance
Tetrabenazine
- US FDA 12
- Health Canada 3
- US price lines 2
- NHS prices 1
- Safety 1
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| XENAZINE | 12.5MG; 25MG | tablet · oral | BAUSCH | Prescription | 15 Aug 2008 |
| TETRABENAZINE | 12.5MG; 25MG | tablet · oral | HETERO LABS LTD V | Prescription | 3 Feb 2016 |
| TETRABENAZINE | 12.5MG; 25MG | tablet · oral | MYLAN | Prescription | 31 Jan 2017 |
| TETRABENAZINE | 25MG | tablet · oral | ACTAVIS LABS FL INC | Prescription | 7 Jul 2017 |
| TETRABENAZINE | 12.5MG; 25MG | tablet · oral | BIONPHARMA | Prescription | 18 Dec 2017 |
| TETRABENAZINE | 12.5MG; 25MG | tablet · oral | DR REDDYS | Prescription | 8 Jan 2018 |
| TETRABENAZINE | 12.5MG; 25MG | tablet · oral | CHARTWELL RX | Prescription | 20 Apr 2018 |
| TETRABENAZINE | 12.5MG; 25MG | tablet · oral | ADAPTIS | Prescription | 22 Jan 2020 |
| TETRABENAZINE | 12.5MG; 25MG | tablet · oral | APOTEX | Prescription | 17 Mar 2020 |
| TETRABENAZINE | 12.5MG; 25MG | tablet · oral | SUN PHARM | Discontinued | 17 Aug 2015 |
| TETRABENAZINE | 12.5MG; 25MG | tablet · oral | HIKMA PHARMS | Discontinued | 8 Apr 2019 |
| TETRABENAZINE | 12.5MG; 25MG | tablet · oral | AJANTA PHARMA LTD | Discontinued | 4 Dec 2020 |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| APO-TETRABENAZINE | 02407590 | 25 MG | TABLET · ORAL | APOTEX INC |
| NITOMAN | 02199270 | 25 MG | TABLET · ORAL | BAUSCH HEALTH, CANADA INC. |
| PMS-TETRABENAZINE | 02402424 | 25 MG | TABLET · ORAL | PHARMASCIENCE INC |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | TETRABENAZINE 12.5 MG TABLET | $0.70194 | per EA | 23 Sep 2026 |
| US NADAC | TETRABENAZINE 25 MG TABLET | $1.33628 | per EA | 23 Sep 2026 |
| NHS Drug Tariff | Tetrabenazine 25mg tablets | £109.02 | 112 tablet | 1 Oct 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Safety signals and safety-related labeling changes
- US FDA 13 Sep 2017 XENAZINE — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.