Prescription medicine
Sodium thiosulfate Brand names: Pedmark
Sodium thiosulfate (Pedmark) is a prescription medicine with an FDA approval on record since 1992. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the sodium thiosulfate FDA label on DailyMed (effective May 26, 2026, Hope Pharmaceuticals); the NDA 20166 record on Drugs@FDA; every sodium thiosulfate label on DailyMed.
Highlights of the record
FDA label of May 26, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageSodium Thiosulfate Injection is indicated for sequential use with sodium nitrite for the treatment of acute cyanide poisoning that is judged to be serious or life-threatening.
Forms and strengths
- 12.5 g/100ml
- 250 mg/ml
Injection (solution).
On the market
- Earliest approval on file
- February 14, 1992 Sodium Thiosulfate, Us Army; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 2 of which 0 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- March 29, 2031 Sodium Thiosulfate injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 540 through July 30, 2026
What is sodium thiosulfate used for?
From the label: indications and usageSodium Thiosulfate Injection is indicated for sequential use with sodium nitrite for the treatment of acute cyanide poisoning that is judged to be serious or life-threatening. When the diagnosis of cyanide poisoning is uncertain, the potential risks associated with Sodium Thiosulfate Injection should be carefully weighed against the potential benefits, especially if the patient is not in extremis. Sodium Thiosulfate Injection, an antidote, is indicated for sequential use with sodium nitrite for treatment of acute cyanide poisoning that is judged to be serious or life-threatening. ( 1 ) Use with caution if the diagnosis of cyanide poisoning is uncertain.
Source: FDA drug label (Sodium Thiosulfate), Hope Pharmaceuticals, effective May 26, 2026 (SPL set 82f55408-2de9-463d-85e8-b39c3b259f0b), via openFDA; the full label on DailyMed
Is there a generic for sodium thiosulfate (Pedmark)?
No generic sodium thiosulfate is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 6 patents for Sodium Thiosulfate injection: the compound patent runs to March 29, 2031; a patent listed only for Pedmark injection runs to July 1, 2039. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1992 earliest approval on file
- 2031 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the sodium thiosulfate label say about other medicines?
The sodium thiosulfate label names no other medicine on this site. The labels of 2 other medicines name sodium thiosulfate. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
Other labels that name sodium thiosulfate
Source: FDA drug label (Sodium Thiosulfate), Hope Pharmaceuticals, effective May 26, 2026 (SPL set 82f55408-2de9-463d-85e8-b39c3b259f0b), via openFDA; the full label on DailyMed
What do FAERS reports show for sodium thiosulfate?
The FDA Adverse Event Reporting System holds 540 reports that list sodium thiosulfate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 78 are coded as a death and 189 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.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Sodium thiosulfate side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other