warnings
WARNINGS A few instances of hyperpyrexia and aseptic (chemical) meningeal irritation have been reported with the use of iodinated I 131 albumin in cisternography. Iodinated I 131 Albumin Injection is not approved for use in cisternography.
Volumex
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- Brand name
- Volumex
- Generic name
- IODINATED I-131 ALBUMIN
- Manufacturer
- Iso-Tex Diagnostics, Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 812240e4-fc28-46c2-92f3-1ba4e029645a
- SPL ID
- 1f46b3df-897f-4a96-9feb-9e5c9dd2864f
- Version
- 5
- Effective date
- 2022-11-21
- Source export date
- 2026-09-28
- Source partition
- 7
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/bb1af06e95bcf9567b07e56fcf3a03c0cac3c7c82ff89d4c970881174949e5b7/drug-label-0007-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:49:44
| Harmonized routes |
|---|
| INTRAVENOUS |
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| application applno | BLA | 017837 | derived:openfda.application_number |
| application number | BLA017837 | openfda.application_number | |
| brand name | Volumex | openfda.brand_name | |
| generic name | IODINATED I-131 ALBUMIN | openfda.generic_name | |
| manufacturer name | Iso-Tex Diagnostics, Inc. | openfda.manufacturer_name | |
| ndc | package | 50914-7720-8 | openfda.package_ndc |
| ndc | product | 50914-7720 | openfda.product_ndc |
| ndc11 | package | 50914772008 | derived:openfda.package_ndc |
| spl id | 1f46b3df-897f-4a96-9feb-9e5c9dd2864f | id | |
| spl set id | 812240e4-fc28-46c2-92f3-1ba4e029645a | set_id | |
| unii | ACH35131L1 | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Although the immunological properties of albumin human are believed to be virtually unaltered by the iodination process, there is a theoretical possibility that allergic reactions may occur in patients receiving additional doses a number of weeks after an initial dose.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.