Active substance
Diazoxide
- US FDA 7
- Health Canada 1
- US price lines 2
- NHS prices 1
- WHO EML 1
- Safety 3
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| PROGLYCEM | 50MG/ML | suspension · oral | TEVA BRANDED PHARM | Prescription | 28 May 1976 |
| DIAZOXIDE | 50MG/ML | suspension · oral | E5 PHARMA INC | Prescription | 20 Dec 2019 |
| DIAZOXIDE | 50MG/ML | suspension · oral | NOVITIUM PHARMA | Prescription | 8 Jul 2020 |
| HYPERSTAT | 15MG/ML | injectable · injection | SCHERING | Discontinued | 22 Jan 1973 |
| PROGLYCEM | 50MG; 100MG | capsule · oral | TEVA BRANDED PHARM | Discontinued | 28 May 1976 |
| DIAZOXIDE | 15MG/ML | injectable · injection | ABRAXIS PHARM | Discontinued | |
| DIAZOXIDE | 15MG/ML | injectable · injection | QUAD PHARMS | Discontinued |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| PROGLYCEM | 00503347 | 100 MG | CAPSULE · ORAL | MERCK CANADA INC |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | DIAZOXIDE 50 MG/ML ORAL SUSP | $7.3764 | per ML | 23 Sep 2026 |
| US NADAC | PROGLYCEM 50 MG/ML ORAL SUSP | $16.4826 | per ML | 23 Sep 2026 |
| NHS Drug Tariff | Diazoxide 50mg tablets | £108.61 | 100 tablet | 1 Oct 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
WHO WHO Model List of Essential Medicines (2025)
- 18.6. Medicines for hypoglycaemia · complementary
Persistent hyperinsulinaemic hypoglycaemia of infancy
Oral > Liquid: 50 mg per mL (EMLc) | Oral > Solid: 50 mg (EMLc)
Safety signals and safety-related labeling changes
- EMA PRAC 4 Sep 2025 PRAC signal: Necrotising enterocolitis neonatal
Action for MAH: update of the product information: Yes - EMA PRAC 10 Apr 2025 PRAC signal: Necrotising enterocolitis neonatal
Action for MAH: update of the product information: No - US FDA 18 Jul 2024 PROGLYCEM — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions
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.