Prescription medicine
68ga-dotatate Brand names: Netspot
68ga-dotatate (Netspot) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the 68ga-dotatate FDA label on DailyMed (effective July 6, 2026); every 68ga-dotatate label on DailyMed.
Highlights of the record
FDA label of July 6, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageNETSPOT, after radiolabeling with gallium-68, is indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients.
Forms and strengths
Kit.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2020 0 Class I among all firms' recalls; latest March 18, 2022
- FAERS reports
- 189 through July 30, 2026
What is 68ga-dotatate used for?
From the label: indications and usageNETSPOT, after radiolabeling with gallium-68, is indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. NETSPOT, after radiolabeling with gallium-68, is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients.
Source: FDA drug label (NETSPOT), Advanced Accelerator Applications USA, Inc, effective July 6, 2026 (SPL set b2b3be70-17d8-4093-896c-f1c54a2cf242), via openFDA; the full label on DailyMed
Is there a generic for 68ga-dotatate (Netspot)?
No generic 68ga-dotatate is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has 68ga-dotatate been recalled?
The FDA's Enforcement Report lists 2 recalls naming 68ga-dotatate since 2020: 0 Class I (the most serious), 1 Class II, 1 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 18, 2022 | Class III | Advanced Accelerator Applications USA, Inc. | Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability studies. |
| January 10, 2020 | Class II | Advanced Accelerator Applications USA, Inc. | Defective Container: loose aluminum cap crimp for the dilution buffer vial present in the NETSPOT Kit (vial 2). |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for 68ga-dotatate?
The FDA Adverse Event Reporting System holds 189 reports that list 68ga-dotatate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1 are coded as a death and 6 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?
- 68ga-dotatate side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other