Prescription medicine
Sodium fluoride f 18 First approved as Fluorine F-18
Sodium fluoride f 18 (Fluorine F-18) is a prescription medicine with an FDA approval on record since 1972. FDA's NDC Directory lists it from 11 generic labelers.
- Generic listed
Check it at the source: the sodium fluoride f 18 FDA label on DailyMed (effective January 7, 2026, 3D Imaging Drug Design and Development LLC); the NDA 17042 record on Drugs@FDA; every sodium fluoride f 18 label on DailyMed.
Highlights of the record
FDA label of January 7, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageSodium Fluoride F 18 Injection is indicated for diagnostic positron emission tomography (PET) imaging of bone to define areas of altered osteogenic activity.
Forms and strengths
Injection; injection (solution).
On the market
- Earliest approval on file
- February 24, 1972 Fluorine F-18, Ge Healthcare; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 24 first December 26, 2012; 15 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 11 of which 11 under generic applications, 0 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)
- No recall recorded
- FAERS reports
- 1,086 through July 30, 2026
What is sodium fluoride f 18 used for?
From the label: indications and usageSodium Fluoride F 18 Injection is indicated for diagnostic positron emission tomography (PET) imaging of bone to define areas of altered osteogenic activity. Sodium Fluoride F 18 Injection is a radioactive diagnostic agent for positron emission tomography (PET) indicated for imaging of bone to define areas of altered osteogenic activity (1).
FDA pharmacologic class: Radioactive Diagnostic Agent.
Source: FDA drug label (Sodium Fluoride F 18), 3D Imaging Drug Design and Development LLC, effective January 7, 2026 (SPL set eeaf4f42-e3c6-4e0a-aa79-89722511eaea), via openFDA; the full label on DailyMed
Is there a generic for sodium fluoride f 18 (Fluorine F-18)?
The FDA approved the first generic sodium fluoride f 18 on December 26, 2012. 24 generic applications are approved; 15 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 sodium fluoride f 18 from 11 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1972 earliest approval on file
- 2012 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the sodium fluoride f 18 label say about other medicines?
The sodium fluoride f 18 label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Sodium fluoride | warnings and precautions | Carcinogenic and mutagenic studies with Sodium Fluoride F18 injection have not been performed. |
Source: FDA drug label (Sodium Fluoride F 18), 3D Imaging Drug Design and Development LLC, effective January 7, 2026 (SPL set eeaf4f42-e3c6-4e0a-aa79-89722511eaea), via openFDA; the full label on DailyMed
What do FAERS reports show for sodium fluoride f 18?
The FDA Adverse Event Reporting System holds 1,086 reports that list sodium fluoride f 18 among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 349 are coded as a death and 388 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.
Reports received each year
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
- Sodium fluoride f 18 side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other