Medicine
Xofigo 30 µCi/mL injection
Xofigo 30 µCi/mL injection is a prescription medicine containing Radium ra-223 dichloride for intravenous use, marketed by Bayer HealthCare 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 room temperature, below 40° C (104° F). Store Xofigo in the original…
Key facts
- Active ingredient (INN)
- Radium ra-223 dichloride
- Brand
- Xofigo
- Strength
- 30 µCi/mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 6 mL
- Marketing authorisation holder
- Bayer HealthCare Pharmaceuticals
- Manufacturer
- Bayer HealthCare Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at room temperature, below 40° C (104° F). Store Xofigo in the original container or equivalent radiation shielding.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- V10XX03 Radium ra223 dichloride
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 20 May 2013
- Identifiers
- RxCUI 1424214, 1424219DailyMed set ID a398400e-bd31-41a9-9696-4f7c06569edeNDC 50419-208Application NDA203971
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 |
|---|---|---|---|
| 6 mL in 1 vial, single-dose | 50419-208-01 | Bayer HealthCare Pharmaceuticals | 20 May 2013 |
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 May 2013 | 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
Clinical summary
Radium ra-223 dichloride is a radioactive alpha-particle emitting therapeutic agent indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease. MedsAcross supplies Radium ra-223 dichloride 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 Radium ra-223 dichlorideFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Xofigo prescribing information (Bayer HealthCare Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Xofigo 30 µCi/mL injection 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.