Gadobutrol Injection
Product Images NDC 65219-281

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

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Gadobutrol (NDC 65219-281). 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

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

Gadob-struc-01.jpg (Gadob Struc 01)
Chemical structure diagram of Gadobutrol, showing the gadolinium ion (Gd3+) centrally complexed by a macrocyclic ligand with attached carboxylate and hydroxyl groups.*
FDA Label Image

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

FDA Label Image

Gadob-img-02.jpg (Gadob Img 02)

FDA Label Image

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

Gadob-label-01.jpg (Gadob Label 01)
Packaging label for Gadobutrol Injection 2 mmol/2 mL (1 mmol/mL) sterile solution by Fresenius Kabi USA, LLC. The label includes dosage information (0.1 mL/kg), indicates intravenous administration, single-dose vials, and storage instructions. The package contains 3 vials of 2 mL each and states the product contains 604.72 mg/mL gadobutrol as the active ingredient.*
FDA Label Image

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

Gadob-label-02.jpg (Gadob Label 02)
Label for Gadobutrol Injection 2 mmol/2 mL (1 mmol/mL) single-dose vial for intravenous administration. The label includes dosage information (0.1 mL/kg), NDC 65219-281-00, and instructions to discard unused portion. Manufactured for Fresenius Kabi USA, LLC, Lake Zurich, IL, product of China.*
FDA Label Image

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

Gadob-label-03.jpg (Gadob Label 03)
Gadobutrol Injection 7.5 mmol/7.5 mL (1 mmol/mL) sterile solution for intravenous use, single-dose vials. The label indicates a dose of 0.1 mL/kg and contains 604.72 mg/mL of gadobutrol as the active ingredient. Packaged by Fresenius Kabi USA, LLC, this box contains 10 vials of 7.5 mL each. The label includes instructions to discard unused portions and cautions it is Rx only.*
FDA Label Image

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

Gadob-label-04.jpg (Gadob Label 04)
Label for Gadobutrol Injection 7.5 mmol/7.5 mL (1 mmol/mL) single-dose vial for intravenous administration. The label indicates a dose of 0.1 mL/kg, includes the NDC 65219-281-03, and states it is for prescription use only. Manufactured for Fresenius Kabi USA, LLC, Lake Zurich, IL. The product is marked as a sterile solution and advises discarding unused portions.*
FDA Label Image

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

Gadob-label-05.jpg (Gadob Label 05)
Gadobutrol Injection 604.72 mg/mL (10 mmol/10 mL) sterile solution for intravenous use, in single-dose vials. The carton contains 10 vials of 10 mL each. Manufactured by Fresenius Kabi USA, LLC. The label highlights dosage information and storage instructions, including 'Dose: 0.1 mL/kg' and the NDC 65219-281-10. The product is Rx only.*
FDA Label Image

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

Gadob-label-06.jpg (Gadob Label 06)
Label for Gadobutrol Injection 10 mmol/10 mL (1 mmol/mL) single-dose vial for intravenous administration. The label includes dosing information at 0.1 mL/kg, NDC 65219-281-08, and states it is a sterile solution. Manufactured for Fresenius Kabi USA, LLC, Lake Zurich, IL, product of China.*
FDA Label Image

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

Gadob-label-07.jpg (Gadob Label 07)
Packaging label for Gadobutrol Injection 15 mmol/15 mL (1 mmol/mL) sterile solution by Fresenius Kabi USA, LLC. The label shows a 10 x 15 mL single-dose vial carton for intravenous administration, with dosing instructions at 0.1 mL/kg. The label includes storage information, active ingredient concentration (604.72 mg/mL gadobutrol), and barcode.*
FDA Label Image

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

Gadob-label-08.jpg (Gadob Label 08)
Label for Gadobutrol Injection 15 mmol/15 mL (1 mmol/mL) in a 15 mL single-dose vial. The label indicates a dose of 0.1 mL/kg and states it is for intravenous administration. It is a sterile solution with an instruction to discard unused portions. Manufactured for Fresenius Kabi USA, LLC, Lake Zurich, IL, product of China. Contains barcode and NDC 65219-281-05.*

* 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.