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NDC 50914-7733-05 Jeanatope 1000 uCi/mL Details
Jeanatope 1000 uCi/mL
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 Information
| NDC | 50914-7733 |
|---|---|
| Product ID | 50914-7733_cfd145b7-bf08-49a8-9995-a08d166f8e54 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Jeanatope |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Iodinated I-125 Albumin |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 1000 |
| Active Ingredient Units | uCi/mL |
| Substance Name | HUMAN SERUM ALBUMIN I-125 |
| Labeler Name | Iso-Tex Diagnostics, Inc. |
| Pharmaceutical Class | Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA] |
| DEA Schedule | n/a |
| Marketing Category | BLA |
| Application Number | BLA017836 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 50914-7733-05 (50914773305)
| NDC Package Code | 50914-7733-5 |
|---|---|
| Billing NDC | 50914773305 |
| Package | 1 VIAL, MULTI-DOSE in 1 CONTAINER (50914-7733-5) / 10 mL in 1 VIAL, MULTI-DOSE |
| Marketing Start Date | 2022-03-09 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |