Medicine
Xenazine 25 mg tablet
Xenazine 25 mg tablet is a prescription medicine containing Tetrabenazine for oral use, marketed by Lundbeck Pharmaceuticals, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F).
Key facts
- Active ingredient (INN)
- Tetrabenazine
- Brand
- Xenazine
- Strength
- 25 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 112 tablets
- Marketing authorisation holder
- Lundbeck Pharmaceuticals
- Manufacturer
- Lundbeck Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- N07XX06 Tetrabenazine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 24 November 2008
- Identifiers
- DailyMed set ID ac768bab-8afa-4446-bc7f-caeeffec0cdaNDC 67386-422Application NDA021894
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 112 tablet in 1 bottle | 67386-422-01 | Lundbeck Pharmaceuticals | 24 November 2008 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 15 August 2008 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Alternatives
Other makers and brands of Tetrabenazine 25 mg tablet.
Other strengths and forms of Tetrabenazine
Clinical summary
Tetrabenazine is a vesicular monoamine transporter 2 inhibitor indicated for the treatment of chorea associated with Huntington’s disease. It is available as tablets for oral use. MedsAcross supplies Tetrabenazine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about TetrabenazineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Xenazine prescribing information (Lundbeck Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Xenazine 25 mg tablet for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.