Prescription medicine
Fludeoxyglucose f 18
Fludeoxyglucose f 18 is a prescription medicine with an FDA approval on record since 1994. FDA's NDC Directory lists it from 24 generic labelers.
- Generic listed
Check it at the source: the fludeoxyglucose f 18 FDA label on DailyMed (effective July 11, 2019, THE FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH); the NDA 20306 record on Drugs@FDA; every fludeoxyglucose f 18 label on DailyMed.
Highlights of the record
FDA label of July 11, 2019; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageFludeoxyglucose F 18 Injection is indicated for positron emission tomography (PET) imaging in the following settings: Fludeoxyglucose F 18 Injection is indicated for positron emission tomography (PET) imaging in the following settings: Oncology: For assessment of abnormal glucose metabolism to assist in the evaluation of malignancy in patients with known or suspected abnormalities found by other testing modalities, o
Forms and strengths
Injection; injection (solution).
On the market
- Earliest approval on file
- August 19, 1994 Fludeoxyglucose F18, Downstate Clincl; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 41 first February 25, 2011; 32 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 25 of which 24 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 2013 0 Class I among all firms' recalls; latest February 17, 2021; 1 more by firms not listed as its makers
- FAERS reports
- 277 through July 30, 2026
What is fludeoxyglucose f 18 used for?
From the label: indications and usageFludeoxyglucose F 18 Injection is indicated for positron emission tomography (PET) imaging in the following settings: Fludeoxyglucose F 18 Injection is indicated for positron emission tomography (PET) imaging in the following settings: Oncology: For assessment of abnormal glucose metabolism to assist in the evaluation of malignancy in patients with known or suspected abnormalities found by other testing modalities, or in patients with an existing diagnosis of cancer. […]
FDA pharmacologic class: Radioactive Diagnostic Agent.
Source: FDA drug label (Fludeoxyglucose F18), THE FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH, effective July 11, 2019 (SPL set dfd91498-4bfc-4d45-a9a3-cee6153ae573), via openFDA; the full label on DailyMed
Is there a generic for fludeoxyglucose f 18?
The FDA approved the first generic fludeoxyglucose f 18 on February 25, 2011. 41 generic applications are approved; 32 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists fludeoxyglucose f 18 from 24 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1994 earliest approval on file
- 2011 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has fludeoxyglucose f 18 been recalled?
The FDA's Enforcement Report lists 3 recalls naming fludeoxyglucose f 18 since 2013: 0 Class I (the most serious), 2 Class II, 1 Class III; 0 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of fludeoxyglucose f 18 and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| February 17, 2021 | Class II | The General Hospital Corporation | Lack of Assurance of Sterility |
| May 18, 2017 | Class III | Lantheus MI Radipharmaceuticals Inc. not a listed maker | Failed Impurities/Degradation Specifications; out of specification result for Acetonitrile residual solvent |
| February 22, 2013 | Class II | Petnet Solution Inc | cGMP Deviation |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for fludeoxyglucose f 18?
The FDA Adverse Event Reporting System holds 277 reports that list fludeoxyglucose f 18 among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 42 are coded as a death and 113 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?
- Other radioactive diagnostic agents
- the pharmacologic class, with prices and generics
- Fludeoxyglucose f 18 side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other