Sodium Fluoride
Sodium Fluoride F-18 · Injection · Intravenous, Dental, Oral
Dosage forms and strengths
Multiple-dose vial containing 370-7,400 MBq/mL ( 10–200 mCi/mL)at EOS reference time of no-carrier-added sodium fluoride F18 in aqueous 0.9% sodium chloride solution. Sodium Fluoride F 18 Injection is a clear, colorless, sterile, pyrogen-free and preservative-free solution for intravenous administration. Multiple-dose vial containing 370-7,400 MBq/mL ( 10–200 mCi/mL) at EOS reference time of no-carrier-added sodium fluoride F18 in aqueous 0.9% sodium chloride solution (3) . Sodium Fluoride F 18 Injection is a clear, colorless, sterile, pyrogen-free and preservative-free solution for intravenous administration.
Side effects
No adverse reactions have been reported for Sodium Fluoride F 18 Injection based on a review of the published literature, publicly available reference sources, and adverse drug reaction reporting systems. However, the completeness of these sources is not known. No adverse reactions have been reported for Sodium Fluoride F 18 Injection based on a review of the published literature, publicly available reference sources, and adverse drug reaction reporting systems (6) . To report SUSPECTED ADVERSE REACTIONS, contact Kreitchman PET Center at 1-212-305-0081 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Description
11.1 Chemical Characteristics Sodium Fluoride F 18 Injection is a positron emitting radiopharmaceutical, containing no-carrier-added, radioactive fluoride F18 that is used for diagnostic purposes in conjunction with PET imaging. It is administered by intravenous injection. The active ingredient, sodium fluoride F18, has the molecular formula Na[18F] with a molecular weight of 40.99, and has the following chemical structure: Na +18 F - Sodium Fluoride F 18 Injection is provided as a ready-to-use, isotonic, sterile, pyrogen-free, preservative-free, clear and colorless solution. Each mL of the solution contains between 370 MBq to 7,400 MBq (10 mCi to 200 mCi) sodium fluoride F18, at the EOS reference time, in 0.9% aqueous sodium chloride. The pH of the solution is between 4.5 and 8. The solution is presented in 30 mL multiple- dose glass vials with variable total volume and total radioactivity in each vial. 11.2 Physical Characteristics Fluoride F18 decays by positron (β+) emission and has a half-life of 109.7 minutes. Ninety-seven percent of the decay results in emission of a positron with a maximum energy of 633 keV and 3% of the decay results in electron capture with subsequent emission of characteristic X-rays of oxygen. The principal photons useful for diagnostic imaging are the 511 keV gamma photons, resulting from the interaction of the emitted positron with an electron (Table 2). Fluorine F18 atom decays to stable 18 O-oxygen. Table 2: Principal Emission Data for Fluoride F18 Radiation/Emission % per Disintegration Mean Energy Positron (β+) 96.73 249.8 keV Gamma (±) Produced by positron annihilation [3] Kocher, D.C. Radioactive Decay Data Tables DOE/TIC-11026, 69, 1981. 193.46 511.0 keV The specific gamma ray constant (point source air kerma coefficient) for fluoride F18 is 5.7 R/hr/mCi (1.35 x 10 -6 Gy/hr/kBq) at 1 cm. The half-value layer (HVL) for the 511 keV photons is 4 mm lead (Pb). A range of values for the attenuation of radiation results from the interposition of various thickness of Pb. The range of attenuation coefficients for this radionuclide is shown in Table 3. For example, the interposition of an 8 mm thickness of Pb with a coefficient of attenuation of 0.25 will decrease the external radiation by 75%. Table 3:Radiation Attenuation of 511 keV Photons by Lead (Pb) Shielding Shield Thickness (Pb) mm Coefficient of Attenuation 0 0.00 4 0.50 8 0.25 13 0.10 26 0.01 39 0.001 52 0.0001 Table 4 lists the fraction of radioactivity remaining at selected time intervals from the calibration time. This information may be used to correct for physical decay of the radionuclide. Table 4: Physical Decay Chart for Fluoride F18 Time Since Calibration Fraction Remaining 0 Calibration time 1.00 15 minutes 0.909 30 minutes 0.826 60 minutes 0.683 110 minutes 0.500 220 minutes 0.250 440 minutes 0.060 12 hours 0.011 24 hours 0.0001
How supplied
Sodium Fluoride F 18 Injection is supplied in a multiple-dose Type I glass vial with (elastomeric) stopper and aluminum crimp seal containing between 370-7,400 MBq/mL (10 to 200 mCi/mL) of no-carrier-added sodium fluoride F18, at the EOS reference time, in aqueous 0.9% sodium chloride solution. The total volume and total radioactivity per vial are variable. Each vial is enclosed in a shielding container of appropriate thickness. The product is available in a 30 mL vial configuration with a variable fill volume. The NDC number is: 62702-500-30 (30 mL) Storage Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F). Use the solution within 8 hours of the EOS reference time. Handling Receipt, transfer, handling, possession, or use of this product is subject to the radioactive material regulations and licensing requirements of the U.S. Nuclear Regulatory Commission, Agreement States or Licensing States as appropriate.
Storage
Storage Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F). Use the solution within 8 hours of the EOS reference time. Handling Receipt, transfer, handling, possession, or use of this product is subject to the radioactive material regulations and licensing requirements of the U.S. Nuclear Regulatory Commission, Agreement States or Licensing States as appropriate.
Label text from the FDA structured product label by Kreitchman PET Center (revised Jan 27, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Sodium Fluoride F-18 in 6 products
- Sodium Fluoride in 6 products
Sodium Fluoride NDC products (12)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 76451-018 | Sodium Fluoride F-18 200 mCi/mL Injection | 3D Imaging Drug Design and Development LLC | ANDA |
| 81759-002 | Sodium Fluoride F-18 200 mCi/mL Injection | BAMF Health Inc. | ANDA |
| 65857-300 | Sodium Fluoride F-18 200 mCi/mL Injection | Cardinal Health 414, LLC | ANDA |
| 62072-500 | Sodium Fluoride F-18 200 mCi/mL Injection | Kreitchman PET Center | ANDA |
| 52768-125 | Sodium Fluoride F-18 200 mCi/mL Injection | Precision Nuclear LLC | ANDA |
| 13267-542 | Sodium Fluoride F-18 600 mCi/mL Injection | THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH | ANDA |
| 53942-581 | Sodium Fluoride .2 mg/mL Mouthwash | Demoulas Super Markets, Inc | OTC MONOGRAPH DRUG |
| 67777-180 | Sodium Fluoride 220 mg/g Gel | Dynarex Corporation | OTC MONOGRAPH DRUG |
| 71141-576 | Sodium Fluoride .1 mg/mL Mouthwash | Lidl US, LLC | OTC MONOGRAPH DRUG |
| 67239-0226 | Sodium Fluoride 2.43 mg/g Paste, Dentifrice | Safco Dental Supply LLC | OTC MONOGRAPH DRUG |
| 67239-0227 | Sodium Fluoride 2.43 mg/g Paste, Dentifrice | Safco Dental Supply LLC | OTC MONOGRAPH DRUG |
| 58657-322 | Sodium Fluoride .5 mg/mL Solution/ Drops | Method Pharmaceuticals, LLC | UNAPPROVED DRUG OTHER |
Frequently asked questions
What are the side effects of Sodium Fluoride?
No adverse reactions have been reported for Sodium Fluoride F 18 Injection based on a review of the published literature, publicly available reference sources, and adverse drug reaction reporting systems. However, the completeness of these sources is not known. No adverse reactions have been reported for Sodium Fluoride F 18 Injection based on a review of the published literature, publicly… See the full label for the complete list.
Who makes Sodium Fluoride?
Sodium Fluoride is listed by 11 labelers in the FDA NDC directory, including 3D Imaging Drug Design and Development LLC, BAMF Health Inc., Cardinal Health 414, LLC, Kreitchman PET Center.