Quick answers
- What is Technetium tc 99M sestamibi used for?
- The FDA-approved label (Kit for the Preparation of Technetium Tc99m Sestamibi, Cardinal Health 414, LLC, September 8, 2025) says: “Myocardial Imaging: Technetium Tc 99m Sestamibi Injection is a myocardial perfusion agent that is indicated for detecting coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects), in evaluating myocardial function and developing information for use in patient management decisions. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Technetium tc 99M sestamibi 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 Technetium tc 99M sestamibi?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Technetium tc 99M sestamibi been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Technetium tc 99M sestamibi?
- 2 companies list prescription products of Technetium tc 99M sestamibi in the FDA NDC Directory, including Jubilant Draximage (USA) Inc. and Cardinal Health 414, LLC.
What Technetium tc 99M sestamibi is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Myocardial Imaging: Technetium Tc 99m Sestamibi Injection is a myocardial perfusion agent that is indicated for detecting coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects), in evaluating myocardial function and developing information for use in patient management decisions. …
— FDA label: Kit for the Preparation of Technetium Tc99m Sestamibi, 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.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
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, for solution · Injection, powder, lyophilized, for solution |
|---|---|
| Route | Intravenous · Parenteral |
| Prescription products | 2 in the FDA NDC Directory |
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.
- Jubilant Draximage (USA) Inc.1 product
- Cardinal Health 414, LLC1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (2)
- ANDA078809Cardinal Health 414 · April 28, 2009
- ANDA078806Jubilant Draximage · April 29, 2009
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| SPL set ID of the quoted label | 8626e756-767a-4a14-9188-658b58185254 |
|---|---|
| FDA labels (SPL) | 2 |
| FDA applications | 2 ANDA |
| Active ingredients (FDA) | TECHNETIUM TC-99M SESTAMIBI |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Kit for the Preparation of Technetium Tc99m Sestamibi, 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 →