Gadobutrol Injection
Product Images NDC 65219-289

Product Visual Gallery

This gallery contains 6 technical images submitted to the FDA as part of the official labeling for Gadobutrol (NDC 65219-289). 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 (Gad03 0000 01)

Chemical structure diagram of Gadobutrol showing its gadolinium ion (Gd3+) complexed with a macrocyclic ligand featuring nitrogen atoms and multiple hydroxyl groups.*

FDA Label Image

Fresenius Kabi Logo (Gad03 0000 02)

FDA Label Image

Principal Display Panel – 30 Mmol/30 mL (1 Mmol/ml) – Shelf Carton (Gad03 0000 03)

Gadobutrol Injection 30 mmol/30 mL (1 mmol/mL) intravenous injection in a bulk package of 10 x 30 mL multiple-dose bottles. The label includes dosing information (0.1 mL/kg), instructions for use, and a note that it is not for direct infusion. Manufactured by Fresenius Kabi USA, LLC.*

FDA Label Image

Principal Display Panel – 30 Mmol/30 mL (1 Mmol/ml) – Bottle Label (Gad03 0000 04)

Gadobutrol Injection 30 mmol/30 mL (1 mmol/mL) intravenous injection multi-dose bottle label. The label includes dosage instructions, storage conditions, and manufacturer Fresenius Kabi USA, LLC. It states the concentration as 604.72 mg/mL and specifies ’Imaging Bulk Package - Not for Direct Infusion.’ The label also contains barcodes and space for lot and expiration dates.*

FDA Label Image

Principal Display Panel – 65 Mmol/65 mL (1 Mmol/ml) – Shelf Carton (Gad03 0000 05)

Label for Gadobutrol Injection 65 mmol/65 mL (1 mmol/mL) sterile solution, NDC 65219-289-65, from Fresenius Kabi USA, LLC. The label states dose as 0.1 mL/kg and indicates the product is for intravenous use only. It is a multiple-dose bottle packaging (10 x 65 mL) labeled as an imaging bulk package not for direct infusion, with instructions to discard 24 hours after initial puncture and to dispense the enclosed Medication Guide to each patient.*

FDA Label Image

Principal Display Panel – 65 Mmol/65 mL (1 Mmol/ml) – Bottle Label (Gad03 0000 06)

Gadobutrol Injection 65 mmol/65 mL (1 mmol/mL) sterile solution, MRI contrast agent by Fresenius Kabi USA, LLC. This intravenous injection comes in a multiple-dose bulk bottle labeled for imaging use only, not for direct infusion. The label includes dosing information, 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.