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Prescription medicine

Sodium thiosulfate

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

Quick answers

What is Sodium thiosulfate used for?
The FDA-approved label (Sodium Thiosulfate, Hope Pharmaceuticals, May 26, 2026) says: “Sodium 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. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Sodium thiosulfate 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 Sodium thiosulfate?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Sodium thiosulfate been recalled?
No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
Who makes Sodium thiosulfate?
2 companies list prescription products of Sodium thiosulfate in the FDA NDC Directory, including Hope Pharmaceuticals and Fennec Pharmaceuticals Inc..

What Sodium thiosulfate is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

Sodium 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. …

— FDA label: Sodium Thiosulfate, Hope Pharmaceuticals, effective May 26, 2026. 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 formsInjection, solution
RouteIntravenous
Prescription products2 in the FDA NDC Directory
Brand namesPedmark

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.

FDA approval history

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA203923
SODIUM THIOSULFATE
Hope PharmsFebruary 14, 2012 3, latest May 7, 2026
2026: Manufacturing (CMC) · 2020: Labeling · 2017: Labeling
NDA212937
PEDMARK
Fennec Pharms IncSeptember 20, 2022 —

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.

Official identifiers

RxCUI (RxNorm)237832, 2618749, 2618755
SPL set ID of the quoted label82f55408-2de9-463d-85e8-b39c3b259f0b
FDA labels (SPL)2
FDA applicationsNDA203923, NDA212937
Active ingredients (FDA)SODIUM THIOSULFATE

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Sodium Thiosulfate, Hope Pharmaceuticals, effective May 26, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. 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 →

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