Prescription medicine
Gallium ga 68 gozetotide Brand names: Illuccix
Gallium ga 68 gozetotide (Illuccix) is a prescription medicine with an FDA approval on record since 2020. FDA's NDC Directory lists it from 1 generic labeler.
- Generic listed
Check it at the source: the gallium ga 68 gozetotide FDA label on DailyMed (effective November 14, 2025, UCSF Radiopharmaceutical Facility); the NDA 212642 record on Drugs@FDA; every gallium ga 68 gozetotide label on DailyMed.
Highlights of the record
FDA label of November 14, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageGallium Ga 68 Gozeotide Injection is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy.
Forms and strengths
- 68 g
Injection (solution); kit.
On the market
- Earliest approval on file
- December 1, 2020 Gallium Ga 68 Gozetotide, Univ Ca Los Angeles; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 2 first May 14, 2026; 2 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 4 of which 1 under generic applications, 3 under brand applications, repackagers included
- Last listed patent
- March 9, 2036 Locametz injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 382 through July 30, 2026
What is gallium ga 68 gozetotide used for?
From the label: indications and usageGallium Ga 68 Gozeotide Injection is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy. with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. […]
FDA pharmacologic class: Radioactive Diagnostic Agent.
Source: FDA drug label (Gallium Ga-68 PSMA-11), NDA212643 (Univ Of Ca San Fran), as published by UCSF Radiopharmaceutical Facility, effective November 14, 2025 (SPL set b6253a7b-0f73-36be-e053-2a95a90a9015), via openFDA; the full label on DailyMed
Is there a generic for gallium ga 68 gozetotide (Illuccix)?
The FDA approved the first generic gallium ga 68 gozetotide on May 14, 2026. 2 generic applications are approved; 2 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists gallium ga 68 gozetotide from 1 labeler under a generic (ANDA) application and from 3 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Gallium Ga 68 Gozetotide injection; a patent listed only for Locametz injection runs to March 9, 2036. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2020 earliest approval on file
- 2026 first generic approved
- 2036 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the gallium ga 68 gozetotide label say about other medicines?
The gallium ga 68 gozetotide label names no other medicine on this site. The labels of 1 other medicine name gallium ga 68 gozetotide. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
Source: FDA drug label (Gallium Ga-68 PSMA-11), NDA212643 (Univ Of Ca San Fran), as published by UCSF Radiopharmaceutical Facility, effective November 14, 2025 (SPL set b6253a7b-0f73-36be-e053-2a95a90a9015), via openFDA; the full label on DailyMed
What do FAERS reports show for gallium ga 68 gozetotide?
The FDA Adverse Event Reporting System holds 382 reports that list gallium ga 68 gozetotide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 20 are coded as a death and 67 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other radioactive diagnostic agents
- the pharmacologic class, with prices and generics
- Gallium ga 68 gozetotide side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other