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] |