Sodium Fluoride Injection
Product Images NDC 76451-018

This is a description of Sodium Fluoride F 18 Injection. The product is a sterile and apyrogenic injection containing [F-18] Fluoride in sterile saline. The recommended use of the product is in accordance with the full labeling. The injection is suitable for 3D imaging and originates from Little Rock, AR, 72205.*

This is a description of a single dose syringe containing Sodium Fluoride F 18 Injection with an activity of 30 mCi, concentration of 20.0 mCi/mL, and a volume of 1.5 mL. It has a lot number of 1308030703 with a calibration date and time of 8-3-13 10:30 am and an expiration date and time of 8-3-13 10:30 pm. It is sterile, non-pyrogenic, and for intravenous use only. A single mL contains 0.37 GBq to 7.4 GBq of no-carrier-added sodium [ISF] fluoride in aqueous 0.9% sodium chloride solution stored at 25˚C (77°F) with excursions from 15-30 °C (59-86°F) permitted. It has a half-life of 109.7 minutes and must be used within 12 hours of EOS (End of Synthesis). It must not be used if cloudy or contains particulate matter. It is manufactured by 3D Imaging, Little Rock, AR 72205.*

This is a description of a single-dose 5 mL syringe of Sodium Fluoride F 18 Injection intended for intravenous diagnostic use. The syringe includes 30 mCi of activity at calibration with a concentration of 20.0 mCi/mL and a volume of 1.5 mL. The lot number is 1308030703, and the calibration date and time are 8-3-13 10:30 am. The expiration date and time are 8-3-13 10:30 pm, 12 hours after calibration. The solution is sterile, non-pyrogenic, and must be used within 12 hours of calibration, with a half-life of 109.7 minutes. The solution contains 0.37 GBq to 7.4 GBq of sodium fluoride in aqueous 0.9% sodium chloride solution at EOS*. It is advised to store it upright in a shielded container and aseptically withdraw and handle doses. It should not be used if it is cloudy or contains particulate matter. Note that EOS= End of Synthesis. Finally, this product is produced by 3D Imaging, Little Rock, AR.*

This is a description of a Sodium Fluoride F18 Injection used for diagnostic purposes. The injection comes in a 10 mL vial with a concentration of 20.0 mCi/mL and contains no-carrier-added sodium [lgF]fluoride. It is sterile and non-pyrogenic and should be used within 12 hours of calibration. The injections should be stored at 25°C in a shielded container and withdrawn aseptically. The lot number is 1308030703, and the calibration date and time were 8-3-13 10:30 am with an expiration date 12 hours after calibration. The half-life is 109.7 min.*