Gadoterate Meglumine Injection
Product Images NDC 65219-084

14 FDA label images from Fresenius Kabi Usa, Llc · Packaging, Regulatory Labels, and Product Appearance

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

Gadot-struc-01.jpg (Gadot Struc 01)

Gadot-struc-01.jpg (Gadot Struc 01)
Chemical structure diagram of gadoterate meglumine showing the gadolinium ion complexed with a macrocyclic ligand on the left and the meglumine molecule on the right.*
FDA Label Image

Gadot-img-01.jpg (Gadot Img 01)

FDA Label Image

Gadot-label-01.jpg (Gadot Label 01)

Gadot-label-01.jpg (Gadot Label 01)
Label for Gadoterate Meglumine Injection, USP 2.5 mmol per 5 mL (0.5 mmol per mL) for intravenous administration. The sterile solution is supplied in 10 x 5 mL single dose vials. Manufactured by Fresenius Kabi USA, LLC with storage instructions and barcode included. Contains 376.9 mg of gadoterate meglumine per mL.*
FDA Label Image

Gadot-label-02.jpg (Gadot Label 02)

Gadot-label-02.jpg (Gadot Label 02)
Gadoterate Meglumine Injection, USP 2.5 mmol per 5 mL (0.5 mmol per mL) sterile solution in a 5 mL single dose vial. Label states it is for intravenous administration, manufactured by Fresenius Kabi USA, LLC. Packaging includes storage instructions and a barcode, with the product marketed as prescription only.*
FDA Label Image

Gadot-label-03.jpg (Gadot Label 03)

Gadot-label-03.jpg (Gadot Label 03)
Label for Gadoterate Meglumine Injection, USP, 2.5 mmol per 5 mL (0.5 mmol per mL) intravenous injection. The label indicates a sterile solution in a 5 mL single dose vial, manufactured for Fresenius Kabi USA, LLC, with storage instructions and a barcode visible.*
FDA Label Image

Gadot-label-04.jpg (Gadot Label 04)

Gadot-label-04.jpg (Gadot Label 04)
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 10 x 10 mL single dose vials, includes a barcode, manufacturer Fresenius Kabi USA, LLC, and storage instructions. The label also notes the product contains 376.9 mg/mL gadoterate meglumine with DOTA and water for injection, marked Rx only.*
FDA Label Image

Gadot-label-05.jpg (Gadot Label 05)

Gadot-label-05.jpg (Gadot Label 05)
Label for Gadoterate Meglumine Injection, USP, 5 mmol per 10 mL (0.5 mmol per mL), an intravenous sterile solution. The label indicates a 10 mL single-dose vial, with instructions to discard unused portions and dispense the Medication Guide separately. Manufactured for Fresenius Kabi USA, LLC, the label includes NDC 65219-082-01 and storage information.*
FDA Label Image

Gadot-label-06.jpg (Gadot Label 06)

Gadot-label-06.jpg (Gadot Label 06)
Label for Gadoterate Meglumine Injection USP 5 mmol per 10 mL (0.5 mmol per mL) sterile solution, intended for intravenous administration. The label indicates a 10 mL single dose vial, manufactured for Fresenius Kabi USA, LLC, with storage instructions and barcode visible. The product is Rx only.*
FDA Label Image

Gadot-label-07.jpg (Gadot Label 07)

Gadot-label-07.jpg (Gadot Label 07)
Label for Gadoterate Meglumine Injection, USP 7.5 mmol per 15 mL (0.5 mmol per mL) sterile solution for intravenous administration. The package contains 10 single dose vials of 15 mL each. Manufactured for Fresenius Kabi USA, LLC. Includes barcode and storage instructions.*
FDA Label Image

Gadot-label-08.jpg (Gadot Label 08)

Gadot-label-08.jpg (Gadot Label 08)
Gadoterate Meglumine Injection, USP, 7.5 mmol per 15 mL (0.5 mmol per mL) sterile solution for intravenous administration. The packaging is for a 15 mL single dose vial with instructions to discard the unused portion. Manufactured for Fresenius Kabi USA, LLC, made in China. The label includes dosage information and storage instructions, and the product is Rx only.*
FDA Label Image

Gadot-label-09.jpg (Gadot Label 09)

Gadot-label-09.jpg (Gadot Label 09)
Label for Gadoterate Meglumine Injection, USP, 7.5 mmol per 15 mL (0.5 mmol per mL) sterile solution in a 15 mL single-dose vial for intravenous administration. Manufactured for Fresenius Kabi USA, LLC, Lake Zurich, IL, made in China. Includes barcode and storage instructions.*
FDA Label Image

Gadot-label-10.jpg (Gadot Label 10)

Gadot-label-10.jpg (Gadot Label 10)
Label for Gadoterate Meglumine Injection, USP 376.9 mg/mL (10 mmol per 20 mL) sterile solution for intravenous administration. The package contains 10 single dose vials of 20 mL each. Label indicates Rx only and includes manufacturer information for Fresenius Kabi USA, LLC. Barcode and storage instructions are visible.*
FDA Label Image

Gadot-label-11.jpg (Gadot Label 11)

Gadot-label-11.jpg (Gadot Label 11)
The carton label for Gadoterate Meglumine Injection, USP, 10 mmol per 20 mL (0.5 mmol per mL) sterile solution for intravenous administration. The label notes a 20 mL single-dose vial with unused portions to be discarded. It is manufactured for Fresenius Kabi USA, LLC, with manufacturing in China. The label includes dosage information and storage instructions, along with the Fresenius Kabi logo.*
FDA Label Image

Gadot-label-12.jpg (Gadot Label 12)

Gadot-label-12.jpg (Gadot Label 12)
Label for Gadoterate Meglumine Injection, USP, 0.5 mmol per mL (10 mmol per 20 mL) sterile solution for intravenous administration in a 20 mL single-dose vial. The label indicates it is manufactured for Fresenius Kabi USA, LLC, located in Lake Zurich, IL, and the product is made in China. The label includes storage instructions and a 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.