Quick answers
- What is Fluorodopa F18 used for?
- The FDA-approved label (Fluorodopa F18, The Feinstein Institutes for Medical Research, January 15, 2021) says: “Fluorodopa F 18 Injection is indicated for use in positron emission tomography (PET) to visualize dopaminergic nerve terminals in the striatum for the evaluation of adult patients with suspected Parkinsonian syndromes (PS). Fluorodopa F 18 PET is an adjunct to other diagnostic evaluations. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Fluorodopa F18 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 Fluorodopa F18?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Fluorodopa F18 been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Fluorodopa F18?
- 1 company lists prescription products of Fluorodopa F18 in the FDA NDC Directory, including The Feinstein Institutes for Medical Research.
What Fluorodopa F18 is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Fluorodopa F 18 Injection is indicated for use in positron emission tomography (PET) to visualize dopaminergic nerve terminals in the striatum for the evaluation of adult patients with suspected Parkinsonian syndromes (PS). Fluorodopa F 18 PET is an adjunct to other diagnostic evaluations. …
— FDA label: Fluorodopa F18, The Feinstein Institutes for Medical Research, effective January 15, 2021. 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 |
|---|---|
| Route | Intravenous |
| Prescription products | 2 in the FDA NDC Directory |
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.
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA200655 FLUORODOPA F18 | Feinstein | October 10, 2019 | 1, latest December 11, 2020 2020: Manufacturing (CMC) |
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 | 37f8c405-ccb6-4fcd-8513-108956bb1674 |
|---|---|
| FDA labels (SPL) | 2 |
| FDA applications | NDA200655 |
| Active ingredients (FDA) | FLUORODOPA F-18 |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Fluorodopa F18, The Feinstein Institutes for Medical Research, effective January 15, 2021; 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 →