Medicine
Xtandi 80 mg tablet
Xtandi 80 mg tablet is a prescription medicine containing Enzalutamide for oral use, marketed by Astellas Pharma, 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 XTANDI capsules and tablets at 20°C to 25°C (68°F to 77°F) in a dry…
Key facts
- Active ingredient (INN)
- Enzalutamide
- Brand
- Xtandi
- Strength
- 80 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 1 bottle
- Marketing authorisation holder
- Astellas Pharma
- Manufacturer
- Astellas Pharma
- Origin register
- US FDA, United States
- Storage
- Store XTANDI capsules and tablets at 20°C to 25°C (68°F to 77°F) in a dry place and keep the container tightly closed. Excursions permitted from 15°C to 30°C (59°F to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L02BB04 Enzalutamide
- HS code (indicative)
- 3004.39Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 4 August 2020
- Identifiers
- RxCUI 1307303, 1307309, 2390644 +3DailyMed set ID b129fdc9-1d8e-425c-a5a9-8a2ed36dfbdfNDC 0469-0725Application NDA213674
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 |
|---|---|---|---|
| 1 bottle in 1 carton / 60 tablet in 1 bottle | 0469-0725-60 | Astellas Pharma | 4 August 2020 |
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.
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
Other strengths and forms of Enzalutamide
Clinical summary
Enzalutamide is an androgen receptor inhibitor indicated for the treatment of patients with castration-resistant prostate cancer (CRPC), among other approved uses. It is available as tablets and capsules for oral use. MedsAcross supplies Enzalutamide 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 EnzalutamideFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Xtandi prescribing information (Astellas Pharma) · U.S. National Library of Medicine, DailyMed
- Xtandi: European public assessment report (EPAR) · European Medicines Agency
- Enzalutamide Accordpharma: European public assessment report (EPAR) · European Medicines Agency
Need Xtandi 80 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.