Medicine
Xofluza 80 mg tablet
Xofluza 80 mg tablet is a prescription medicine containing Baloxavir marboxil for oral use, marketed by Genentech, 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 tablets in their blister package at 20°C to 25°C (68°F to 77°F)…
Key facts
- Active ingredient (INN)
- Baloxavir marboxil
- Brand
- Xofluza
- Strength
- 80 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 1 blister pack
- Marketing authorisation holder
- Genentech
- Manufacturers
- GenentechSportpharm
- Origin register
- US FDA, United States
- Storage
- Store tablets in their blister package at 20°C to 25°C (68°F to 77°F), excursions are permitted between 15°C and 30°C (59°F to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 24 October 2018
- Identifiers
- RxCUI 2536740, 2536742, 2100008 +5DailyMed set ID b58b2899-4d22-41e1-8f0c-bdead8917694, e49e1a61-1b7c-4be5-ac84-af6240b511e7NDC 85766-058, 50242-877Application NDA210854
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 / 1 tablet, film coated in 1 blister pack | 50242-877-01 | Genentech | 26 March 2021 |
| 1 blister pack in 1 carton / 1 tablet, film coated in 1 blister pack | 85766-058-01 | Sportpharm | 22 August 2025 |
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 Baloxavir marboxil
Clinical summary
Baloxavir marboxil is a polymerase acidic endonuclease inhibitor indicated for treatment of acute uncomplicated influenza in patients 5 years of age and older, among other approved uses. MedsAcross supplies Baloxavir marboxil 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 Baloxavir marboxilFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Xofluza prescribing information (Genentech) · U.S. National Library of Medicine, DailyMed
- Xofluza: European public assessment report (EPAR) · European Medicines Agency
Need Xofluza 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.