Dotarem Injection
Product Images NDC 67684-2000

6 FDA label images from Guerbet Llc · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 6 technical images submitted to the FDA as part of the official labeling for Dotarem (NDC 67684-2000). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Guerbet 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

100 mL Presentation Box (100ml Box)

100 mL Presentation Box (100ml Box)
DOTAREM (gadoterate meglumine) Injection 50 mmol per 100 mL (0.5 mmol per mL) sterile solution pharmacy bulk package for intravenous administration. The label states to withdraw contents within 24 hours and that it is not for direct infusion. Each mL contains 376.9 mg gadoterate meglumine and 0.25 mg DOTA with water for injection. Manufactured and distributed by Guerbet LLC.*
FDA Label Image

100 mL Presentation Label (100ml Label)

100 mL Presentation Label (100ml Label)
DOTAREM (gadoterate meglumine) Injection 50 mmol per 100 mL sterile solution for intravenous administration. The label includes a pharmacy bulk package warning, stating it is not for direct infusion. The concentration is equivalent to 376.9 mg/mL gadoterate meglumine, provided by Guerbet LLC as the labeler.*
FDA Label Image

Guerbet Logo (Guerbet)

FDA Label Image

Structure (Structure)

Structure (Structure)
Chemical structure diagram of gadoterate meglumine, the active ingredient in DOTAREM injection, showing the gadolinium ion complexed with ligands and the meglumine moiety.*
FDA Label Image

Vial 20ml Label Pbp

Vial 20ml Label Pbp
Label for DOTAREM (gadoterate meglumine) Injection 50 mmol per 100 mL (0.5 mmol per mL) sterile solution for intravenous administration. Pharmacy bulk package by Guerbet LLC, manufactured and distributed by Guerbet LLC, Princeton, New Jersey. Contains 376.9 mg of gadoterate meglumine per mL, packaged as a multiple dose container not for direct infusion. Includes usage and storage instructions and the NDC 67684-2001-4.*
FDA Label Image

Vial Bottle Label Pbp

Vial Bottle Label Pbp
Label for Dotarem (gadoterate meglumine) Injection, 376.9 mg/mL sterile solution for intravenous administration. The label indicates it is a pharmacy bulk package not for direct infusion, used as a multiple-dose container. It includes storage instructions and manufacturer Guerbet LLC information.*

* 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.