Medicine
Xadago 50 mg tablet
Xadago 50 mg tablet is a prescription medicine containing Safinamide for oral use, marketed by MDD US Operations, 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 between 15°C to 30°C (59°F to 86°F).
Key facts
- Active ingredient (INN)
- Safinamide
- Brand
- Xadago
- Strength
- 50 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 1 blister pack, 1 bottle
- Marketing authorisation holder
- MDD US Operations
- Manufacturer
- MDD US Operations
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (77°F), excursions permitted between 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
- N04BD03 Safinamide
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 8 May 2017
- Identifiers
- RxCUI 1922466, 1922472, 1922474 +1DailyMed set ID c4d65f28-983f-42b4-bb23-023ae0fe81b2NDC 27505-110Application NDA207145
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 blister pack in 1 carton / 14 tablet, film coated in 1 blister pack | 27505-110-14 | MDD US Operations | 8 May 2017 |
| 1 bottle in 1 carton / 30 tablet, film coated in 1 bottle | 27505-110-30 | MDD US Operations | 8 May 2017 |
| 1 bottle in 1 carton / 90 tablet, film coated in 1 bottle | 27505-110-90 | MDD US Operations | 8 May 2017 |
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 Safinamide
Clinical summary
Safinamide is a monoamine oxidase type B inhibitor indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease (PD) experiencing "off" episodes. It is available as tablets for oral use. MedsAcross supplies Safinamide 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 SafinamideFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Xadago prescribing information (MDD US Operations) · U.S. National Library of Medicine, DailyMed
- Xadago: European public assessment report (EPAR) · European Medicines Agency
Need Xadago 50 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.