Fludeoxyglucose F-18 Injection
Product Images NDC 16129-001
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This gallery contains 5 technical images submitted to the FDA as part of the official labeling for Fludeoxyglucose F-18 (NDC 16129-001). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.
As provided by Pharmalogic South Carolina, Llc, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.
30 mL Lead Pig (shield) Container Label (49fd0c9f 7aee 4244 A15e 33a389f26e3b 02)
This is a description of Fludeoxyglucose F 18 Injection, a radioactive material used for diagnostic intravenous purposes only. It is a multiple dose vial with a concentration range of 0.74 GBg/mL to 11.1 GBg/mL (20 mCiimL to 300 mCimL) and is sterile, non-pyrogenic. It is composed of fluoro-D-glucose and 4.5 mg of sodium chloride in citrate buffer, with a shelf life of 12 hours after EOS*. The manufacture is Shertech Laboratories, LLC, and it should be stored at 20°C to 25°C (68 to 7T°F), with excursions permitted to 15°C-30°C (S9°F-86°F). The correct dosage is calculated from the date and time of calibration. Do not use if it is cloudy or contains particulate matter.
[*F] fluoro-D-glucose
@EOS" End Of Synthesis*
Vial Label 30 mL (49fd0c9f 7aee 4244 A15e 33a389f26e3b 03)
This is a description of a medication with NDC# 16129-001-30, which is a sterile, non-pyrogenic diagnostic injection for intravenous use. It is a fludeoxyglucose F 18 injection (['*F] FDG, USP) containing 0.74 GB/mL to 11.1 GBq/mL (20 mCiimL to 300 mCimL) of no carrier added 2-deoxy-2-[*F] luoro-D-glucose and 4.5 mg of sodium chloride in citrate buffer. The item is a multiple dose vial and the LOT# NP expires 12 hours after EOS*. The medication must be stored at 20°C 0 26°C (B8°F-77°F) with excursions permitted to 15°C-30°C (S9°F-86°F) and upright in a shielded container. It is manufactured by Shertech Laboratories, LLC and the calibration date must be used to calculate the correct dosage. The text also includes a caution that the medication is radioactive and must not be used if cloudy or contains particulate matter.*
10 mL Lead Pig (shield) Container Label (49fd0c9f 7aee 4244 A15e 33a389f26e3b 04)
This is the description of a diagnostic drug called Fludeoxyglucose F 18 Injection used in intravenous procedures. It comes in a range of activity levels and concentrations, and contains no carrier added 2-deoxy-2-{F] fluoro-D-glucose @EOS* as well as sodium chloride in Gtrate buffer. It is sterile, non-pyrogenic and the calibration time and date should be taken into account for calculating the correct dosage. The drug is stored at 20°C to 25°C (68°F to 77°F) in a shielded container, and must be withdrawn aseptically before handling. The HalfLife of the drug is 109.7 minutes. The manufacturer is Shertech Laboratories, LLC.*
Vial Label 10 mL (49fd0c9f 7aee 4244 A15e 33a389f26e3b 05)
This is a description of Fludeoxyglucose F 18 injection used for diagnostic purposes. It is a sterile, non-pyrogenic solution of 0.74 GBq/mL to 11.1 GBq/mL (20 mCi/mL to 300 mCi/mL) of 2-deoxy-2-[18F] fluoro-D-glucose in citrate buffer with 4.5 mg of sodium chloride. The solution comes in a multiple-dose vial with a lot number and an expiration time of 12 hours after End Of Synthesis. The manufacturer is Shertech Laboratories, LLC. It is a radioactive material, and caution is advised. The correct dosage needs to be calculated based on the calibration date, and aseptic handling is necessary. Storage instructions include keeping the vial upright in a shielded container at 20°C-25°C (68°F-77°F) with excursions permitted to 15°C-30°C (59°F-86°F).*
* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.