Quick answers
- What is Tc 99M medronate used for?
- The FDA-approved label (Kit for the Preparation of Technetium Tc 99m Medronate, Cardinal Health 414, LLC, September 8, 2025) says: “Technetium Tc 99m medronate may be used as a bone imaging agent to delineate areas of altered osteogenesis.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Tc 99M medronate have a boxed warning?
- No. None of the 2 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Tc 99M medronate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Tc 99M medronate been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started June 6, 2018 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Tc 99M medronate?
- 2 companies list prescription products of Tc 99M medronate in the FDA NDC Directory, including Sun Pharmaceutical Industries, Inc. and Cardinal Health 414, LLC.
What Tc 99M medronate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Technetium Tc 99m medronate may be used as a bone imaging agent to delineate areas of altered osteogenesis.
— FDA label: Kit for the Preparation of Technetium Tc 99m Medronate, Cardinal Health 414, LLC, effective September 8, 2025. Read the full label on DailyMed →
The FDA has 2 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 2 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, powder, lyophilized, for solution |
|---|---|
| Route | Intravenous |
| Prescription products | 2 in the FDA NDC Directory |
| Brand names | Kit for the Preparation of Technetium Tc 99m Medronate |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Sun Pharmaceutical Industries, Inc.1 product
- Cardinal Health 414, LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA018107 TECHNETIUM TC-99M MEDRONATE KIT | Cardinal Health 414 | February 17, 1981 | 14, latest May 22, 2025 2025: Labeling · 2020: Labeling · 2015: Manufacturing (CMC) |
| NDA018124 CIS-MDP | Sun Pharm Inds Inc | August 29, 1979 | 15, latest May 22, 2025 2025: Labeling · 2016: Manufacturing (CMC) · 2015: Manufacturing (CMC) |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
June 6, 2018 · Class II · Terminated · D-1040-2018
Lack of assurance of sterility: Technetium TC-99M Medronate Kit has a reported breach of sterility.
Kit for the Preparation of Technetium Tc99m Medronate, 20mg in 10 mL vial, packaged in a) 5-count box (NDC 45567-0040-1), b) 30-count box, NDC 45567-0040-2 , Rx only, Manufactured by: Pharmalucence, Inc., Billerica, MA 0 — Pharmalucence, Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| SPL set ID of the quoted label | 54608807-4df6-49ba-b065-59a19ef224c4 |
|---|---|
| FDA labels (SPL) | 2 |
| FDA applications | NDA018107, NDA018124 |
| Active ingredients (FDA) | TECHNETIUM TC-99M MEDRONATE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Kit for the Preparation of Technetium Tc 99m Medronate, Cardinal Health 414, LLC, effective September 8, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →