Quick answers
- What is Technetium TC-99M used for?
- The FDA-approved label (Ultra-Technekow V4, Curium US LLC, October 16, 2024) says: “The Ultra-Technekow™ V4 generator is a source of sodium pertechnetate Tc 99m for use in the preparation of FDA-approved diagnostic radiopharmaceuticals, as described in the labeling of these diagnostic radiopharmaceutical kits. Sodium Pertechnetate Tc 99m is used IN ADULTS as an agent for …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Technetium TC-99M 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?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Technetium TC-99M been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Technetium TC-99M?
- 3 companies list prescription products of Technetium TC-99M in the FDA NDC Directory, including Curium US LLC, Shine Spect USA, LLC and Lantheus Medical Imaging, Inc..
What Technetium TC-99M is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
The Ultra-Technekow™ V4 generator is a source of sodium pertechnetate Tc 99m for use in the preparation of FDA-approved diagnostic radiopharmaceuticals, as described in the labeling of these diagnostic radiopharmaceutical kits. Sodium Pertechnetate Tc 99m is used IN ADULTS as an agent for …
— FDA label: Ultra-Technekow V4, Curium US LLC, effective October 16, 2024. 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, solution |
|---|---|
| Route | Intravenous |
| Prescription products | 17 in the FDA NDC Directory |
| Brand names | Ultra-Technekow V4, Technelite |
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.
- Curium US LLC13 products
- Shine Spect USA, LLC2 products
- Lantheus Medical Imaging, Inc.2 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA017243 ULTRA-TECHNEKOW V4 | Curium | November 23, 1973 | 32, latest January 30, 2017 2017: Manufacturing (CMC) · 2015: Labeling · 2015: Manufacturing (CMC) |
| NDA017771 TECHNELITE | Shine | November 16, 1976 | 29, latest January 20, 2023 2023: Labeling · 2016: Manufacturing (CMC) · 2016: Manufacturing (CMC) |
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 | 98947d99-5be5-461e-ad36-7425d3646389 |
|---|---|
| FDA labels (SPL) | 2 |
| FDA applications | NDA017243, NDA017771 |
| Active ingredients (FDA) | TECHNETIUM TC-99M SODIUM PERTECHNETATE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Ultra-Technekow V4, Curium US LLC, effective October 16, 2024; 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 →