NDC 65174-200
Drax Exametazime
Kit For The Preparation Of Technetium Tc 99m Exametazime For Leukocyte Labeling
Drax Exametazime is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Jubilant Draximage Inc., Dba Jubilant Radiopharma. The primary component is Technetium Tc-99m Exametazime.
| Product ID | 65174-200_171d8803-5e5a-43ad-b865-4f7ca914151f |
| NDC | 65174-200 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Drax Exametazime |
| Generic Name | Kit For The Preparation Of Technetium Tc 99m Exametazime For Leukocyte Labeling |
| Dosage Form | Injection, Powder, Lyophilized, For Solution |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 2017-08-17 |
| Marketing Category | NDA / NDA |
| Application Number | NDA208870 |
| Labeler Name | Jubilant DraxImage Inc., dba Jubilant Radiopharma |
| Substance Name | TECHNETIUM TC-99M EXAMETAZIME |
| Active Ingredient Strength | 1 mg/1 |
| Pharm Classes | Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
Packaging
NDC 65174-200-05
5 VIAL in 1 CARTON (65174-200-05) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (65174-200-01)
| Marketing Start Date | 2017-08-17 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 65174-200-01 [65174020001]
Drax Exametazime INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
| Marketing Category | NDA |
| Application Number | NDA208870 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-08-17 |
NDC 65174-200-05 [65174020005]
Drax Exametazime INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
| Marketing Category | NDA |
| Application Number | NDA208870 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-08-17 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| TECHNETIUM TC-99M EXAMETAZIME | .5 mg/1 |
OpenFDA Data
| SPL SET ID: | fa7811f9-2803-4126-8037-8f3e56462f9c |
| Manufacturer | |
| UNII |
Pharmacological Class
- Radioactive Diagnostic Agent [EPC]
- Radiopharmaceutical Activity [MoA]
- Radioactive Diagnostic Agent [EPC]
- Radiopharmaceutical Activity [MoA]
Trademark Results [Drax Exametazime]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DRAX EXAMETAZIME 87406433 not registered Live/Pending |
Jubilant DraxImage Inc. 2017-04-11 |
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