FDA Orange Book
Is there a generic for Xofigo?
Xofigo contains radium ra-223 dichloride. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Xofigo (radium ra-223 dichloride).
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Xofigo products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intravenous | 162mCi/6ML (27mCi/ML) | Marketed (Rx) | None | 0 | None |
NDA 203971, held by BAYER HEALTHCARE PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Xofigo NDC codes
Questions
Is there a generic for Xofigo?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Xofigo (radium ra-223 dichloride).
What is the generic name for Xofigo?
The active ingredient in Xofigo is radium ra-223 dichloride, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.