warnings
WARNINGS The theoretical possibility of allergic reactions should be considered in patients who receive multiple doses.
Kit for the Preparation of Technetium Tc 99m Mebrofenin
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
- Kit for the Preparation of Technetium Tc 99m Mebrofenin
- Generic name
- KIT FOR THE PREPARATION OF TECHNETIUM TC 99M MEBROFENIN
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 11492bd5-2ade-4eb4-a23c-b9be99c0d51a
- SPL ID
- 20bf6038-c480-0b7f-e063-6394a90a8d65
- Version
- 11
- Effective date
- 2024-08-28
- Source export date
- 2026-09-28
- Source partition
- 3
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:17:58
| 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 | ANDA | 078242 | derived:openfda.application_number |
| application number | ANDA078242 | openfda.application_number | |
| brand name | Kit for the Preparation of Technetium Tc 99m Mebrofenin | openfda.brand_name | |
| generic name | KIT FOR THE PREPARATION OF TECHNETIUM TC 99M MEBROFENIN | openfda.generic_name | |
| manufacturer name | Sun Pharmaceutical Industries, Inc. | openfda.manufacturer_name | |
| ndc | package | 45567-0455-1 | openfda.package_ndc |
| ndc | package | 45567-0455-2 | openfda.package_ndc |
| ndc | product | 45567-0455 | openfda.product_ndc |
| ndc11 | package | 45567045501 | derived:openfda.package_ndc |
| ndc11 | package | 45567045502 | derived:openfda.package_ndc |
| spl id | 20bf6038-c480-0b7f-e063-6394a90a8d65 | id | |
| spl set id | 11492bd5-2ade-4eb4-a23c-b9be99c0d51a | set_id | |
| unii | 7PV0B6ED98 | 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 Urticaria and rash have been rarely reported with the use of Technetium Tc 99m Mebrofenin since market introduction. Rare cases of chills and nausea have been reported with related compounds. Infrequently, death has been reported in association with the use of this class of agents.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.