warnings
WARNINGS Aseptic meningitis and pyrogenic reactions have been reported following cisternography with MEGATOPE. The safety and effectiveness of MEGATOPE for cisternography have not been established. MEGATOPE is not approved for this use.
Megatope
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
- Megatope
- Generic name
- IODINATED I-131 ALBUMIN
- Manufacturer
- Iso-Tex Diagnostics, Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 62ca4278-8cc9-46b7-8f3c-303ce6a9c155
- SPL ID
- a0a63fb3-6957-4446-8bf0-67c91325f753
- Version
- 4
- Effective date
- 2023-09-01
- Source export date
- 2026-10-12
- Source partition
- 5
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/13cbfcd236c665f0ee69e2d9141331148dcdff45d1679c92f029cfba27dd74a2/drug-label-0005-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 01:40:53
| 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 | Megatope | openfda.brand_name | |
| generic name | IODINATED I-131 ALBUMIN | openfda.generic_name | |
| manufacturer name | Iso-Tex Diagnostics, Inc. | openfda.manufacturer_name | |
| ndc | package | 50914-7731-4 | openfda.package_ndc |
| ndc | product | 50914-7731 | openfda.product_ndc |
| ndc11 | package | 50914773104 | derived:openfda.package_ndc |
| spl id | a0a63fb3-6957-4446-8bf0-67c91325f753 | id | |
| spl set id | 62ca4278-8cc9-46b7-8f3c-303ce6a9c155 | 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 The following adverse reactions have been identified with the use of radioiodinated albumin products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Immune System Disorders: Hypersensitivity
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.