Dotarem Injection
Product Images NDC 67684-2000

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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® is an injection containing 50 mmol per 100 mL of Gadoterate Meglumine, which is a sterile solution. It is a Pharmacy Bulk Pack that cannot be used directly and can be used multiple times within 24 hours by dispensing single preparations with a suitable transfer device. The Pharmacy Bulk Package should be used within 24 hours of puncture and any unused portion should be discarded. The usual dosage can be found in the package insert.*
FDA Label Image

100 mL Presentation Label (100ml Label)

100 mL Presentation Label (100ml Label)
Bonly NDC 6768420004 is a sterile solution of H (Gadoterate Meglumine) Injection used for intravenous administration. It contains 50 mmol per 100 mL and 0.5 mmol per mL of 23288 sterile solution. The Pharmacy Bulk Package is intended for withdrawal by medical professionals only and is not for direct infusion. The contents must be withdrawn within 24 hours.*
FDA Label Image

Guerbet Logo (Guerbet)

FDA Label Image

Structure (Structure)

FDA Label Image

Vial 20ml Label Pbp

Vial 20ml Label Pbp
This is a description of Dotarem® Pharmacy Bulk Package, a sterile solution for intravenous administration containing Gadoterate Meglumine, used as a multiple dose container for dispensing single preparations with a suitable transfer device. It should be stored at 25°C (77°F) and should be used within 24 hours after initial puncture. The pharmacy bulk package is not for direct infusion, and any unused portion should be discarded. The usual dosage can be found in the package insert.*
FDA Label Image

Vial Bottle Label Pbp

Vial Bottle Label Pbp
Dotarem® is a sterile solution of Gadoterate Meglumine, used for intravenous administration, with a concentration of 0.5 mmol per mL. It is considered as a Pharmacy Bulk Package, designed for dispensing single preparations with a suitable transfer device, rather than for direct infusion. Each mL of Dotarem® contains 376.9 mg of Gadoterate Meglumine, 0.25 mg of DOTA and water for injection. The recommended storage temperature is 25°C (77°F) with permitted excursions between 15°-30°C (59°-86°F). The pharmacy bulk package should be used within 24 hours after initial puncture and discard any unused portion. The recommended dosage depends on the patient's condition and must be prescribed by a physician. Manufactured by Liebel-Harsheirm Cornpany LLC, and distributed by Guerbet LLC.*

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.