FDA Orange Book
Is there a generic for Pixclara?
Pixclara contains floretyrosine f-18. 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 Pixclara (floretyrosine f-18). The Orange Book shows its last listed exclusivity ends September 11, 2031.
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Pixclara products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intravenous | 5-300mCi/ML | Marketed (Rx) | None | 0 | None |
NDA 218592, held by TELIX PHARMACEUTICALS US INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Pixclara exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | September 11, 2031 | 218592 |
Pixclara NDC codes
Questions
Is there a generic for Pixclara?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Pixclara (floretyrosine f-18). The Orange Book shows its last listed exclusivity ends September 11, 2031.
What is the generic name for Pixclara?
The active ingredient in Pixclara is floretyrosine f-18, 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.