NDC 65219-086
Gadoterate Meglumine
Gadoterate Meglumine
Gadoterate Meglumine is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Gadoterate Meglumine.
Product ID | 65219-086_afd3cf46-3d9c-4d0e-a02a-42cf846ba1e7 |
NDC | 65219-086 |
Product Type | Human Prescription Drug |
Proprietary Name | Gadoterate Meglumine |
Generic Name | Gadoterate Meglumine |
Dosage Form | Injection |
Route of Administration | INTRAVENOUS |
Marketing Start Date | 2022-06-20 |
Marketing Category | ANDA / |
Application Number | ANDA215304 |
Labeler Name | Fresenius Kabi USA, LLC |
Substance Name | GADOTERATE MEGLUMINE |
Active Ingredient Strength | 377 mg/mL |
Pharm Classes | Gadolinium-based Contrast Agent [EPC], Magnetic Resonance Contrast Activity [MoA] |
NDC Exclude Flag | N |
Listing Certified Through | 2023-12-31 |