NDC 50914-7733
Jeanatope
Iodinated I-125 Albumin
Jeanatope is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Iso-tex Diagnostics, Inc.. The primary component is Human Serum Albumin I-125.
| Product ID | 50914-7733_4179cd6e-50e9-4efb-badc-b1d92243454f |
| NDC | 50914-7733 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Jeanatope |
| Generic Name | Iodinated I-125 Albumin |
| Dosage Form | Injection, Solution |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 2022-03-09 |
| Marketing Category | BLA / |
| Application Number | BLA017836 |
| Labeler Name | Iso-Tex Diagnostics, Inc. |
| Substance Name | HUMAN SERUM ALBUMIN I-125 |
| Active Ingredient Strength | 1000 uCi/mL |
| Pharm Classes | Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |