| NDC Code | 65174-200-05 |
| Package Description | 5 VIAL in 1 CARTON (65174-200-05) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (65174-200-01) |
| Product NDC | 65174-200 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Proprietary Name | Drax Exametazime |
| Non-Proprietary Name | Kit For The Preparation Of Technetium Tc 99m Exametazime For Leukocyte Labeling |
| Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Usage | INTRAVENOUS |
| Start Marketing Date | 20170817 |
| Marketing Category Name | NDA |
| Application Number | NDA208870 |
| Manufacturer | Jubilant DraxImage Inc., dba Jubilant Radiopharma |
| Substance Name | TECHNETIUM TC-99M EXAMETAZIME |
| Strength | .5 |
| Strength Unit | mg/1 |
| Pharmacy Classes | Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA] |