Kit for the Preparation of Technetium Tc 99M Medronate
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 Medronate
- Generic name
- TC 99M MEDRONATE
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 703d347c-e240-408a-b69d-9713e958a201
- SPL ID
- 3010d5a9-2402-c30a-e063-6394a90a73ab
- Version
- 11
- Effective date
- 2025-03-11
- 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 05:20:41
| 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 | NDA | 018124 | derived:openfda.application_number |
| application number | NDA018124 | openfda.application_number | |
| brand name | Kit for the Preparation of Technetium Tc 99M Medronate | openfda.brand_name | |
| generic name | TC 99M MEDRONATE | openfda.generic_name | |
| manufacturer name | Sun Pharmaceutical Industries, Inc. | openfda.manufacturer_name | |
| ndc | package | 45567-0040-2 | openfda.package_ndc |
| ndc | package | 45567-0040-1 | openfda.package_ndc |
| ndc | product | 45567-0040 | openfda.product_ndc |
| ndc11 | package | 45567004001 | derived:openfda.package_ndc |
| ndc11 | package | 45567004002 | derived:openfda.package_ndc |
| spl id | 3010d5a9-2402-c30a-e063-6394a90a73ab | id | |
| spl set id | 703d347c-e240-408a-b69d-9713e958a201 | set_id | |
| unii | X89XV46R07 | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS: This class of compounds is known to complex cations such as calcium. Particular caution should be used with patients who have, or may be predisposed to hypocalcemia (i.e., alkalosis). Preliminary reports indicate impairment of brain scans using Sodium Pertechnetate Tc 99m Injection which have been preceded by a bone scan using an agent containing stannous ions. The impairment may result in false-positive or false-negative brain scans. It is recommended, where feasible, that brain scans precede bone imaging procedures. Alternatively, a brain imaging agent such as Technetium Tc 99m Pentetate Injection may be employed. The biodistribution of technetium Tc 99m medronate may be altered in the presence of high levels of certain cations (iron, calcium, and aluminum). This may result in reduced uptake of radionuclide in the skeleton and increased extraosseal uptake, which may potentially degrade imaging quality. High levels of these cations may be caused by concomitant medications or medical conditions (e.g., iron overload, hypercalcemia, etc.). Most cases were observed after iron infusion. (See PRECAUTIONS, Drug Interactions .)
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS: Several adverse reactions due to Technetium Tc 99m Medronate Injection have been reported. These were usually hypersensitivity reactions characterized by itching, various skin rashes, hypotension, chills, nausea, and vomiting. There have also been rare cases of dizziness and asthenia associated with the use of Technetium Tc 99m Medronate.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.