Quick answers
- What is Copper cu 64 dotatate used for?
- The FDA-approved label (Detectnet, Curium Us LLC, January 31, 2025) says: “Detectnet is indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult patients. Detectnet is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult patients.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Copper cu 64 dotatate 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 Copper cu 64 dotatate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Copper cu 64 dotatate been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Copper cu 64 dotatate?
- 1 company lists prescription products of Copper cu 64 dotatate in the FDA NDC Directory, including Curium US LLC.
What Copper cu 64 dotatate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Detectnet is indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult patients. Detectnet is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult patients.
— FDA label: Detectnet, Curium Us LLC, effective January 31, 2025. 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.
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, solution |
|---|---|
| Route | Intravenous |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Detectnet |
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.
- Curium US LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA213227 DETECTNET | Curium | September 3, 2020 | 1, latest December 22, 2021 2021: 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
| SPL set ID of the quoted label | f898c8a7-beb7-4318-a8ea-6f058d69342b |
|---|---|
| FDA labels (SPL) | 1 |
| FDA applications | NDA213227 |
| Active ingredients (FDA) | COPPER OXODOTREOTIDE CU-64 |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Detectnet, Curium Us LLC, effective January 31, 2025; 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 →