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
- Technetium Tc 99m Medronate
- Generic name
- TECHNETIUM TC 99M MEDRONATE
- Manufacturer
- Jubilant DraxImage Inc., dba Jubilant Radiopharma
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 3c91d0d8-6cc5-834c-bda0-aa83a873b9fb
- SPL ID
- 71674538-1da8-436f-be11-7e964a2c5b05
- Version
- 4
- Effective date
- 2025-03-05
- Source export date
- 2026-10-12
- Source partition
- 11
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 02:42:06
| 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 | 018035 | derived:openfda.application_number |
| application number | NDA018035 | openfda.application_number | |
| brand name | Technetium Tc 99m Medronate | openfda.brand_name | |
| generic name | TECHNETIUM TC 99M MEDRONATE | openfda.generic_name | |
| manufacturer name | Jubilant DraxImage Inc., dba Jubilant Radiopharma | openfda.manufacturer_name | |
| ndc | package | 65174-660-30 | openfda.package_ndc |
| ndc | product | 65174-660 | openfda.product_ndc |
| ndc11 | package | 65174066030 | derived:openfda.package_ndc |
| spl id | 71674538-1da8-436f-be11-7e964a2c5b05 | id | |
| spl set id | 3c91d0d8-6cc5-834c-bda0-aa83a873b9fb | set_id | |
| unii | 73OS0QIN3O | 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 who may be predisposed to, hypocalcemia (i.e., alkalosis). The contents of the kit before preparation are not radioactive. However, after the sodium pertechnetate Tc-99m is added, adequate shielding of the final preparation must be maintained. Preliminary reports indicate impairment of brain images using Sodium Pertechnetate Tc 99m Injection which have been preceded by bone imaging using an agent containing stannous ions. The impairment may result in false-positive or false-negative brain images. It is recommended, where feasible, that brain imaging using Sodium Pertechnetate Tc 99m Injection precede bone imaging procedures. Alternatively, a brain imaging agent such as technetium Tc-99m pentetate 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 cases of allergic dermatological reactions have been reported in association with the use of Technetium Tc 99m Medronate. Several reactions have also been reported in association with other radiopharmaceuticals of the diphosphonate class, particularly Technetium Tc 99m Medronate. These are usually hypersensitivity reactions characterized by itching, various skin rashes, hypotension, chills, nausea, fever, and vomiting. One death secondary to cardiac arrhythmia following the administration of Technetium Tc 99m Medronate has been reported. In addition, one case of cardiac arrest in a patient also undergoing pulmonary function testing one and one-half hours after the performance of a bone scan using Technetium Tc 99m Medronate has been reported.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.