Quick answers
- What is Ioflupane I-123 used for?
- The FDA-approved label (DaTscan, Medi-Physics Inc. dba GE Healthcare., April 24, 2026) says: “DATSCAN is indicated as an adjunct to other diagnostic evaluations for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging in adult patients with: suspected Parkinsonian syndromes (PS) or suspected dementia with Lewy bodies (DLB). …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Ioflupane I-123 have a boxed warning?
- No. None of the 2 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Ioflupane I-123?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Ioflupane I-123 been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Ioflupane I-123?
- 2 companies list prescription products of Ioflupane I-123 in the FDA NDC Directory, including Curium US LLC and Medi-Physics Inc. dba GE Healthcare..
What Ioflupane I-123 is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
DATSCAN is indicated as an adjunct to other diagnostic evaluations for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging in adult patients with: suspected Parkinsonian syndromes (PS) or suspected dementia with Lewy bodies (DLB). …
— FDA label: DaTscan, Medi-Physics Inc. dba GE Healthcare., effective April 24, 2026. Read the full label on DailyMed →
The FDA has 2 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
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.
0 of 2 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution |
|---|---|
| Route | Intravenous |
| Prescription products | 2 in the FDA NDC Directory |
| Brand names | Datscan |
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
- Medi-Physics Inc. dba GE Healthcare.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA022454 DATSCAN | Ge Hlthcare Inc | January 14, 2011 | 5, latest April 15, 2026 2026: Labeling · 2022: Labeling · 2022: Efficacy |
Generic approvals (1)
- ANDA213792Curium · March 30, 2022
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 | ef7804d7-c691-495b-8aaf-5bc54fd5d9f6 |
|---|---|
| FDA labels (SPL) | 2 |
| FDA applications | NDA022454, 1 ANDA |
| Active ingredients (FDA) | IOFLUPANE I-123 |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — DaTscan, Medi-Physics Inc. dba GE Healthcare., effective April 24, 2026; 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 →