Prescription medicine
Sodium nitrite and sodium thiosulfate Brand names: Nithiodote
Sodium nitrite and sodium thiosulfate (Nithiodote) is a prescription medicine with an FDA approval on record since 2011. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the sodium nitrite and sodium thiosulfate FDA label on DailyMed (effective October 6, 2025, Hope Pharmaceuticals); the NDA 201444 record on Drugs@FDA; every sodium nitrite and sodium thiosulfate label on DailyMed.
Highlights of the record
FDA label of October 6, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
LIFE THREATENING HYPOTENSION AND METHEMOGLOBIN FORMATION.
Sodium nitrite can cause serious adverse reactions and death in humans, even at doses less than twice the recommended therapeutic dose. Sodium nitrite causes hypotension and methemoglobin formation, which diminishes oxygen carrying capacity. Hypotension and methemoglobin formation can occur concurrently or separately. Because of these risks, sodium nitrite should be used to treat acute life-threatening cyanide poisoning and be used with caution in patients where the diagnosis of cyanide poisoning is uncertain. Patients should be closely monitored to ensure adequate perfusion and oxygenation during treatment with sodium nitrite. Alternative therapeutic approaches should be considered in patients known to have diminished oxygen or cardiovascular reserve (e.g. smoke inhalation victims, pre-existing anemia, cardiac or respiratory compromise), and those at higher risk of developing methemoglobinemia (e.g., congenital methemoglobin reductase deficiency) as they are at greater risk for potentially life-threatening adverse events related to the use of sodium nitrite. [See Warnings and Precautions (5.1 and 5.2) ] WARNING: LIFE-THREATENING HYPOTENSION AND METHEMOGLOBIN FORMATION See full prescribing information for complete boxed warning. […]
Used for
From the label: indications and usageNITHIODOTE is indicated for the treatment of acute cyanide poisoning that is judged to be serious or life-threatening.
Forms and strengths
Kit.
On the market
- Earliest approval on file
- January 14, 2011 Nithiodote, Hope Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- December 24, 2031 Nithiodote 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
What is sodium nitrite and sodium thiosulfate used for?
From the label: indications and usageNITHIODOTE is indicated for the treatment of acute cyanide poisoning that is judged to be serious or life-threatening. When the diagnosis of cyanide poisoning is uncertain, carefully weigh the potentially life-threatening risks associated with NITHIODOTE against the potential benefits, especially if the patient is not in extremis. NITHIODOTE, an antidote, is indicated for the 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 (NITHIODOTE), Hope Pharmaceuticals, effective October 6, 2025 (SPL set ff4941b3-9901-4aab-adcf-c5327bede34e), via openFDA; the full label on DailyMed
Is there a generic for sodium nitrite and sodium thiosulfate (Nithiodote)?
No generic sodium nitrite and sodium thiosulfate is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 8 patents for Nithiodote injection: the compound patent runs to December 24, 2031. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2011 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 nitrite and sodium thiosulfate label say about other medicines?
The sodium nitrite and sodium thiosulfate label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Nitric oxide | warnings and precautions | Use sodium nitrite with caution in the presence of concomitant antihypertensive medications, diuretics or volume depletion due to diuretics, or drugs known to increase vascular nitric oxide, such as PDE5 inhibitors. |
Check sodium nitrite and sodium thiosulfate against other medicines
Source: FDA drug label (NITHIODOTE), Hope Pharmaceuticals, effective October 6, 2025 (SPL set ff4941b3-9901-4aab-adcf-c5327bede34e), via openFDA; the full label on DailyMed
What next?
- Check an interaction
- what two or more labels say about each other