Gadoterate Meglumine Injection
Product Images NDC 65219-088
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Product Visual Gallery
This gallery contains 5 technical images submitted to the FDA as part of the official labeling for Gadoterate Meglumine (NDC 65219-088). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.
As provided by Fresenius Kabi Usa, 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.
Fresenius Kabi Logo (Gad01 0000 02)
Principal Display Panel – 50 Mmol Per 100 mL Tray Label (Gad01 0000 03)
Principal Display Panel – 50 Mmol Per 100 mL Carton (Gad01 0000 04)
This is a description of Gadoterate Meglumine Injection, USP. It is a sterile solution with 0.5 mmol per mL used for intravenous administration. The medication comes in a Pharmacy Bulk Package, which is not for direct infusion. Each vial contains 100 mL of the solution, and it should be withdrawn within 24 hours of initial puncture. The medication guide must be dispensed to each patient. The usual dosage is described in the package insert. The manufacturing company is Hll Fresenius, located in Lake Zurich, IL, and the product is made in China. The NDC number for this medication is 65219-088-06. Each mL of the solution contains 3769 mg of Gadoterate meglumine, 0.25mg of DOTA, and water for injection.*
Principal Display Panel – 50 Mmol Per 100 mL Vial Label (Gad01 0000 05)
This is a description of the Pharmacy Bulk Package of Gadoterate Meglumine Injection, USP. It is a sterile solution with a concentration of 50 mmol per 100 ml, used for intravenous administration with a suitable transfer device. The contents of the package must be used within 24 hours after initial puncture, and any unused portion must be discarded. The usual dosage is indicated in the package insert. The 100 ml multiple dose vial should not be used for direct infusion. Each ml contains 3769 mg of gadoterate meglumine, 0.25 mg of DOTA, and water for injection. The solution must be stored between 15° to 30°C (59° to 86°F). The manufacturer is indicated as Schering AG Zurich, L. 60047, Made in China, and the product is assigned with NDC65219-08806.*
* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.