NDC 65219-080
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 | 65219-080_afd3cf46-3d9c-4d0e-a02a-42cf846ba1e7 |
| NDC | 65219-080 |
| 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 |