Gadobutrol Injection
Product Images NDC 65219-287

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

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Gadobutrol (NDC 65219-287). 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 of Gadobutrol showing the gadolinium ion (Gd3+) surrounded by a macrocyclic ligand and attached to multiple functional groups including hydroxyl and carboxylate moieties.*
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)
Label for Gadobutrol Injection 30 mmol/30 mL (1 mmol/mL) multiple-dose bottles. The packaging indicates a dose of 0.1 mL/kg, with a total of 10 x 30 mL bottles. It is labeled as an imaging bulk package not for direct infusion, for intravenous use only, and includes handling instructions such as discarding 24 hours after initial puncture. The label shows the NDC 65219-287-30 and is manufactured by Fresenius Kabi USA, LLC.*
FDA Label Image

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

Gadob-label-02.jpg (Gadob Label 02)
Label for Gadobutrol Injection 30 mL vial, concentration 30 mmol/30 mL (1 mmol/mL) or 604.72 mg/mL, designed as an imaging bulk package not for direct infusion. The sterile solution is for intravenous use only in an automated contrast injection system. Label includes dosage, storage instructions, manufacturer Fresenius Kabi USA, LLC, and barcode.*
FDA Label Image

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

Gadob-label-03.jpg (Gadob Label 03)
Gadobutrol Injection 65 mmol/65 mL (1 mmol/mL) sterile solution in a multiple-dose bulk package. The label indicates a dosage of 0.1 mL/kg, intravenous use, and a package size of 10 x 65 mL bottles. It is RX only and manufactured by Fresenius Kabi USA, LLC. The label notes discarding 24 hours after initial puncture and that this is an imaging bulk package not for direct infusion.*
FDA Label Image

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

Gadob-label-04.jpg (Gadob Label 04)
Label for Gadobutrol Injection 65 mmol/65 mL (1 mmol/mL) sterile solution for intravenous injection, multiple-dose bottle, imaging bulk package not for direct infusion. Contains labeling for dose 0.1 mL/kg. Manufactured by Fresenius Kabi USA, LLC, Lake Zurich, IL. Provides storage instructions and notes to discard 24 hours after initial puncture.*

* 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.