Jeanatope
- Product NDC
- 50914-7733
- 11-digit product format
- 509147733
- Labeler code
- 50914
- Product ID
- 50914-7733_4179cd6e-50e9-4efb-badc-b1d92243454f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Iodinated I-125 Albumin
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Iso-Tex Diagnostics, Inc.
- Application
- BLA017836
- Marketing category
- BLA
- Marketing start
- 2022-03-09
- Marketing end
- 0000-00-00
- Substance
- HUMAN SERUM ALBUMIN I-125
- Active strength
- 1000 uCi/mL
- Pharmacologic classes
- Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50914-7733-5 | 50914773305 | 1 VIAL, MULTI-DOSE in 1 CONTAINER (50914-7733-5) > 10 mL in 1 VIAL, MULTI-DOSE | 2022-03-09 | 0000-00-00 | No | No | Current |