Ioflupane I 123 Injection, Solution
Product Images NDC 69945-166

4 FDA label images from Curium Us Llc · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 4 technical images submitted to the FDA as part of the official labeling for Ioflupane I 123 (NDC 69945-166). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Curium Us 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.

FDA Label Image

Figure 1,2,3,4 (Ioflupane I 123 01)

Figure 1,2,3,4 (Ioflupane I 123 01)
A set of four brain imaging scans labeled Figure 1 through Figure 4 showing radiotracer uptake patterns. The images depict areas of radiotracer concentration used to visualize brain structures, likely related to the use of Ioflupane I 123 injection for diagnostic imaging.*
FDA Label Image

The Chemical Name For Ioflupane I-123 Is N-ω-fluoropropyl-2β-carbomethoxy-3β-(4- [123i]iodophenyl)nortropane And It Has The Following Structural Formula: (Ioflupane I 123 02)

The Chemical Name For Ioflupane I-123 Is N-ω-fluoropropyl-2β-carbomethoxy-3β-(4- [123i]iodophenyl)nortropane And It Has The Following Structural Formula: (Ioflupane I 123 02)
Chemical structure diagram of Ioflupane I-123 shown as a molecular formula with labeled groups including a methyl ester (CO2Me) and an iodine-123 isotope attached to a benzene ring.*
FDA Label Image

Principal Display Panelndc 69945-166-05ioflupane I 123 Injection185 Mbq (5 Mci) Per 2.5 mL At Calibration74 Mbq (2 Mci) Per 1 mLradiopharmaceutical For Intravenous Use Onlysingle-dose Vial – Discard Unused Portion.recommended Dosage: See Prescribing Information.each mL Contains: 74 Mbq (2 Mci) Of Ioflupane I 123 At Calibration Date And Time, 0.07 (0.13 mcg ioflupane, 5.7 mg acetic acid, 7.8 mg sodium acetate, 0.05 ml of dehydrated alcohol (ethanol).Store upright at controlled room temperature 20°C to 25°C (68°F to 77°F) in a shielded container.Rx onlyTotal Activity: 185 MBq (5 mCi) at calibrationRadioactivity Concentration: 74 MBq/mL (2 mCi/mL)Total Volume: 2.5 mLCal. time: 1200 ET (1100 CT)Expires 7 hours after calibration time.Cal. date:Lot #: CAUTIONRADIOACTIVE MATERIAL CURIUM™ LogoManufactured by: Curium US LLC, 2703 Wagner Place, Maryland Heights, MO 63043R10/2021 A166C0)

Principal Display Panelndc 69945-166-05ioflupane I 123  Injection185 Mbq (5 Mci) Per 2.5 mL At Calibration74 Mbq (2 Mci) Per 1 mLradiopharmaceutical For Intravenous Use Onlysingle-dose Vial – Discard Unused Portion.recommended Dosage: See Prescribing Information.each mL Contains: 74 Mbq (2 Mci) Of Ioflupane I 123 At Calibration Date And Time, 0.07 (0.13 mcg ioflupane, 5.7 mg acetic acid, 7.8 mg sodium acetate, 0.05 ml of dehydrated alcohol (ethanol).Store upright at controlled room temperature 20°C to 25°C (68°F to 77°F) in a shielded container.Rx onlyTotal Activity: 185 MBq (5 mCi) at calibrationRadioactivity Concentration: 74 MBq/mL (2 mCi/mL)Total Volume: 2.5 mLCal. time: 1200 ET (1100 CT)Expires 7 hours after calibration time.Cal. date:Lot #:  CAUTIONRADIOACTIVE MATERIAL CURIUM™ LogoManufactured by: Curium US LLC, 2703 Wagner Place, Maryland Heights, MO 63043R10/2021     A166C0)
Label for Ioflupane I 123 Injection, 2 mCi/mL, an intravenous radiopharmaceutical solution by Curium US LLC. The label includes product name, strength, total activity, radioactivity concentration, volume, calibration time, recommended dosage note, and storage instructions. It also features caution warnings for radioactive material and specifies single-dose vial usage.*
FDA Label Image

Principal Display Panelndc 69945-166-05ioflupane I 123 Injection185 Mbq (5 Mci) Per 2.5 mL At Calibration[74 Mbq (2 Mci) Per 1 mL]radiopharmaceutical (For Intravenous Use OnlySingle-Dose Vial – Discard Unused Portion.Cal. time:1200 ET (1100 CT)Cal. date:Lot #: Volume: 2.5 mLRadioactive Concentration:74 MBq/mL (2 mCi/mL)Total Activity:185 MBq (5 mCi)Recommended Dosage:See Prescribing InformationRx onlyStore upright at controlled room temperature 20°C to 25°C (68°F to 77°F) in a shielded container. Expires 7 hours after calibration time.Each mL contains 74 MBq(2 mCi) of Ioflupane I 123 atcalibration, 0.07)

Principal Display Panelndc 69945-166-05ioflupane I 123  Injection185 Mbq (5 Mci) Per 2.5 mL At Calibration[74 Mbq (2 Mci) Per 1 mL]radiopharmaceutical (For Intravenous Use OnlySingle-Dose Vial – Discard Unused Portion.Cal. time:1200 ET (1100 CT)Cal. date:Lot #:  Volume: 2.5 mLRadioactive Concentration:74 MBq/mL (2 mCi/mL)Total Activity:185 MBq (5 mCi)Recommended Dosage:See Prescribing InformationRx onlyStore upright at controlled room temperature 20°C to 25°C (68°F to 77°F) in a shielded container. Expires 7 hours after calibration time.Each mL contains 74 MBq(2 mCi) of Ioflupane I 123 atcalibration, 0.07)
Ioflupane I 123 Injection label for a 2.5 mL single-dose vial containing 185 MBq (5 mCi) per vial or 74 MBq (2 mCi) per mL. The radiopharmaceutical is for intravenous use only, with instructions to discard unused portions. The label includes calibration time, volume, radioactive concentration, total activity, lot number, recommended dosage details, and storage instructions. Manufactured by Curium US LLC, Maryland Heights, MO, it also features a radioactive material caution symbol.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.