Quick answers
- What is Radium ra 223 dichloride used for?
- The FDA-approved label (Xofigo, Bayer HealthCare Pharmaceuticals Inc., March 2, 2026) says: “Xofigo is indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease. Xofigo is an alpha particle-emitting radioactive therapeutic agent indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Radium ra 223 dichloride have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Radium ra 223 dichloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Radium ra 223 dichloride been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Radium ra 223 dichloride?
- 1 company lists prescription products of Radium ra 223 dichloride in the FDA NDC Directory, including Bayer HealthCare Pharmaceuticals Inc..
What Radium ra 223 dichloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Xofigo is indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease. Xofigo is an alpha particle-emitting radioactive therapeutic agent indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease.
— FDA label: Xofigo, Bayer HealthCare Pharmaceuticals Inc., effective March 2, 2026. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Forms and how it is given
| Dosage forms | Injection |
|---|---|
| Route | Intravenous |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Xofigo |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA203971 XOFIGO | Bayer Hlthcare | May 15, 2013 | 10, latest December 10, 2019 2019: Labeling · 2018: Labeling · 2018: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 1424214, 1424219 |
|---|---|
| SPL set ID of the quoted label | a398400e-bd31-41a9-9696-4f7c06569ede |
| FDA labels (SPL) | 1 |
| FDA applications | NDA203971 |
| Active ingredients (FDA) | RADIUM RA-223 DICHLORIDE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Xofigo, Bayer HealthCare Pharmaceuticals Inc., effective March 2, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →