Prescription medicine
Technetium tc 99m sulfur colloid
Technetium tc 99m sulfur colloid is a prescription medicine with an FDA approval on record since 1974. FDA's NDC Directory lists it from 1 generic labeler.
- Generic listed
Check it at the source: the technetium tc 99m sulfur colloid FDA label on DailyMed (effective September 13, 2024); the NDA 17456 record on Drugs@FDA; every technetium tc 99m sulfur colloid label on DailyMed.
Highlights of the record
FDA label of September 13, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageTechnetium Tc 99m Sulfur Colloid Injection is indicated: In adults, to assist in the: localization of lymph nodes draining a primary tumor in patients with breast cancer or malignant melanoma when used with a hand-held gamma counter.
Forms and strengths
Kit.
On the market
- Earliest approval on file
- September 24, 1974 Technetium Tc 99M Sulfur Colloid, Ge Healthcare; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 2 of which 1 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2024 0 Class I among all firms' recalls; latest November 22, 2024
- FAERS reports
- 7 through July 30, 2026
What is technetium tc 99m sulfur colloid used for?
From the label: indications and usageTechnetium Tc 99m Sulfur Colloid Injection is indicated: In adults, to assist in the: localization of lymph nodes draining a primary tumor in patients with breast cancer or malignant melanoma when used with a hand-held gamma counter. evaluation of peritoneo-venous (LeVeen) shunt patency. In adults and pediatric patients, for imaging: areas of functioning reticuloendothelial cells in the liver, spleen and bone marrow. studies of esophageal transit and, gastroesophageal reflux, and detection of pulmonary aspiration of gastric contents. […]
Source: FDA drug label (Kit for the Prepartion of Technetium Tc99m Sulfur Colloid), Sun Pharmaceutical Industries, Inc., effective September 13, 2024 (SPL set eeaf70fd-46bd-4fec-ba9d-2366fdf07888), via openFDA; the full label on DailyMed
Is there a generic for technetium tc 99m sulfur colloid?
No generic technetium tc 99m sulfur colloid is approved (Drugs@FDA, October 8, 2026).
FDA's NDC Directory lists technetium tc 99m sulfur colloid from 1 labeler under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1974 earliest approval on file
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has technetium tc 99m sulfur colloid been recalled?
The FDA's Enforcement Report lists 1 recall naming technetium tc 99m sulfur colloid since 2024: 0 Class I (the most serious), 1 Class II, 0 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| November 22, 2024 | Class II | Jubilant Draximage Inc., dba Jubilant Radiopharma | Failed Stability Specifications |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for technetium tc 99m sulfur colloid?
The FDA Adverse Event Reporting System holds 7 reports that list technetium tc 99m sulfur colloid among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2 are coded as a death and 4 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Technetium tc 99m sulfur colloid side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other