Gadoterate Meglumine Injection
Product Images NDC 65219-084

Product Visual Gallery

This gallery contains 14 technical images submitted to the FDA as part of the official labeling for Gadoterate Meglumine (NDC 65219-084). 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.

FDA Label Image

Structural Formula (Gad00 0001 01)

Chemical structure of gadoterate meglumine, showing the gadolinium ion complexed with a macrocyclic ligand and the meglumine molecule.*

FDA Label Image

Fresenius Kabi Logo (Gad00 0001 02)

FDA Label Image

Principal Display Panel – 2.5 Mmol Per 5 mL Tray Label (Gad00 0001 03)

Label for Gadoterate Meglumine Injection, USP 2.5 mmol per 5 mL (0.5 mmol per mL) sterile solution for intravenous administration. The label specifies a 10 x 5 mL single-dose vial package, containing 376.9 mg/mL of gadoterate meglumine. It is manufactured for Fresenius Kabi USA, LLC, with storage instructions and a barcode included.*

FDA Label Image

Principal Display Panel – 2.5 Mmol Per 5 mL Carton (Gad00 0001 04)

Packaging label for Gadoterate Meglumine Injection, USP, 2.5 mmol per 5 mL (0.5 mmol per mL), for intravenous administration. The label indicates a sterile solution in a 5 mL single dose vial, manufactured by Fresenius Kabi USA, LLC. It includes storage instructions, dosage guidance, and a barcode with NDC 65219-080-01.*

FDA Label Image

Principal Display Panel – 2.5 Mmol Per 5 mL Vial Label (Gad00 0001 05)

Label for Gadoterate Meglumine Injection, USP, 2.5 mmol per 5 mL (0.5 mmol per mL) sterile solution for intravenous administration in a 5 mL single dose vial. Manufactured for Fresenius Kabi USA, LLC, Lake Zurich, IL, and made in China. Storage instructions and barcode are also shown.*

FDA Label Image

Principal Display Panel – 5 Mmol Per 10 mL Tray Label (Gad00 0001 06)

Label for Gadoterate Meglumine Injection USP, 5 mmol per 10 mL (0.5 mmol per mL) sterile solution for intravenous administration. Available in 10 single-dose vials of 10 mL each. Contains 376.9 mg/mL of gadoterate meglumine with 0.25 mg of DOTA and water for injection. Manufactured for Fresenius Kabi USA, LLC, Lake Zurich, IL, with storage instructions noted.*

FDA Label Image

Principal Display Panel – 5 Mmol Per 10 mL Carton (Gad00 0001 07)

Packaging label for Gadoterate Meglumine Injection, USP 5 mmol per 10 mL (0.5 mmol per mL) sterile solution for intravenous administration. The label indicates a 10 mL single-dose vial, manufactured for Fresenius Kabi USA, LLC, with storage instructions and usage warnings. The label also includes a barcode and website URL for Fresenius Kabi.*

FDA Label Image

Principal Display Panel – 5 Mmol Per 10 mL Vial Label (Gad00 0001 08)

Label for Gadoterate Meglumine Injection USP, 5 mmol per 10 mL (0.5 mmol per mL), intravenous sterile solution. The single-dose vial contains 10 mL and is for intravenous administration only. Manufactured for Fresenius Kabi USA, LLC, Lake Zurich, Illinois. Storage instructions specify 25°C with permitted excursions. Made in China.*

FDA Label Image

Principal Display Panel – 7.5 Mmol Per 15 mL Tray Label (Gad00 0001 09)

Label for Gadoterate Meglumine Injection, USP, 7.5 mmol per 15 mL (0.5 mmol per mL), an intravenous sterile solution. The label states 10 x 15 mL single dose vials, with storage instructions and a barcode. Manufactured for Fresenius Kabi USA, LLC, Lake Zurich, IL, and made in China.*

FDA Label Image

Principal Display Panel – 7.5 Mmol Per 15 mL Carton (Gad00 0001 10)

Packaging label for Gadoterate Meglumine Injection, USP 7.5 mmol per 15 mL (0.5 mmol per mL) sterile solution. It is intended for intravenous administration in a 15 mL single-dose vial. Manufactured for Fresenius Kabi USA, LLC, the label includes dosage concentration, storage instructions, and a barcode, with the product made in China.*

FDA Label Image

Principal Display Panel – 7.5 Mmol Per 15 mL Vial Label (Gad00 0001 11)

Label for Gadoterate Meglumine Injection, USP, 7.5 mmol per 15 mL (0.5 mmol per mL) intravenous injection, sterile solution. The label indicates a 15 mL single dose vial with instructions to discard unused portion. Manufactured for Fresenius Kabi USA, LLC, Lake Zurich, IL, and made in China. Storage instructions specify 25°C with permitted excursions to 15°-30°C.*

FDA Label Image

Principal Display Panel – 10 Mmol Per 20 mL Tray Label (Gad00 0001 12)

Label for Gadoterate Meglumine Injection, USP, 10 mmol per 20 mL (0.5 mmol per mL) intravenous injection by Fresenius Kabi USA, LLC. The sterile solution comes in 10 x 20 mL single dose vials. Each mL contains 376.9 mg gadoterate meglumine, 0.25 mg DOTA, and water for injection. The label includes storage instructions, barcode, and manufacturing details.*

FDA Label Image

Principal Display Panel – 10 Mmol Per 20 mL Carton (Gad00 0001 13)

The image shows a label for Gadoterate Meglumine Injection, USP with a strength of 10 mmol per 20 mL (0.5 mmol per mL) for intravenous administration. It is a sterile solution in a 20 mL single-dose vial with instructions to discard unused portions. The product is manufactured for Fresenius Kabi USA, LLC and includes storage and dosage information along with the NDC number 65219-086-01.*

FDA Label Image

Principal Display Panel – 10 Mmol Per 20 mL Vial Label (Gad00 0001 14)

Label for Gadoterate Meglumine Injection, USP 10 mmol per 20 mL (0.5 mmol per mL) sterile solution for intravenous administration in a 20 mL single-dose vial. Manufactured for Fresenius Kabi USA, LLC, printed with storage instructions and barcode.*

* 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.