Active substance
Sodium nitrite
- US FDA 1
- WHO EML 1
- Safety 2
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| SODIUM NITRITE | 300MG/10ML (30MG/ML) | solution · intravenous | HOPE PHARMS | Prescription | 14 Feb 2012 |
WHO WHO Model List of Essential Medicines (2025)
- 4.2. Antidotes and other substances used in poisonings > Specific · core
Harmful effects of or exposure to noxious substances, chiefly nonmedicinal as to source, not elsewhere classified
Parenteral > General injections > IV: 30 mg per mL in 10 mL ampoule
Safety signals and safety-related labeling changes
- US FDA 13 Jan 2021 NITHIODOTE — safety-related labeling change
Labeling sections changed: Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 13 Jan 2021 SODIUM NITRITE — safety-related labeling change
Labeling sections changed: Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.