Quick answers
- What is DaTscan?
- DaTscan is a brand name of Ioflupane I-123, a prescription medicine. The FDA NDC Directory lists 1 DaTscan product in 1 strength and form.
- Who makes DaTscan?
- Ge Hlthcare Inc holds the FDA application for DaTscan (NDA022454, approved January 14, 2011).
- Is there a generic or store brand of DaTscan?
- Yes. The FDA NDC Directory lists 1 other product with the same active ingredients, strength and form as a DaTscan product, 1 of them generic. Ask your pharmacist whether one is right for you.
- Has DaTscan been recalled?
- No recall linked to DaTscan products (by their NDC code or label) appears in the FDA enforcement reports we use.
What DaTscan is
Each DaTscan product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Ioflupane I-123 · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| ioflupane I-123 2 mCi/mL injection, solution (intravenous) | DaTscan | 1 product, 1 company | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Ioflupane I-123 →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA022454 | Ge Hlthcare Inc | January 14, 2011 | 1 |
Companies that list DaTscan
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of DaTscan products.
- Medi-Physics Inc. dba GE Healthcare.1 product
Recalls
No recall linked to DaTscan products (by their NDC code or label) appears in the FDA enforcement reports.
Sources
- 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 labeling (SPL, 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
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.