gadoterate meglumine
gadoterate meglumine is listed in the FDA National Drug Code directory with 14 NDC codes, marketed under brand names including DOTAREM, Gadoterate Meglumine, gadoterate meglumine. Available dosage forms: injection, injection, solution.
Drug Details
- Generic Name
- gadoterate meglumine
- Brand Names
- DOTAREM, Gadoterate Meglumine, gadoterate meglumine, CLARISCAN
- Application Number
- NDA204781
- Sponsor
- Guerbet LLC
- NDC Codes
- 14
- Dosage Forms
- INJECTION, INJECTION, SOLUTION
- Routes
- INTRAVENOUS
- Active Ingredients
- GADOTERATE MEGLUMINE
Indications and Usage
1 INDICATIONS AND USAGE Gadoterate Meglumine Injection is a gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity. Gadoterate Meglumine Injection is a gadolinium-based contrast agent indicated: for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity. ( 1 )