Active substance
Tolbutamide
- US FDA 18
- UK MHRA 6
- NHS prices 1
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| ORINASE | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | tablet · oral | PHARMACIA AND UPJOHN | Discontinued | 31 May 1957 |
| ORINASE DIAGNOSTIC | EQ 1GM BASE/VIAL | injectable · injection | PHARMACIA AND UPJOHN | Discontinued | 22 Jun 1961 |
| TOLBUTAMIDE | 500MG | tablet · oral | SANDOZ | Discontinued | 10 Jul 1974 |
| TOLBUTAMIDE | 500MG | tablet · oral | WATSON LABS | Discontinued | 30 Jan 1979 |
| TOLBUTAMIDE | 500MG | tablet · oral | PHARMOBEDIENT | Discontinued | 10 Apr 1979 |
| TOLBUTAMIDE | 500MG | tablet · oral | ALRA | Discontinued | 3 Aug 1979 |
| TOLBUTAMIDE | 500MG | tablet · oral | PARKE DAVIS | Discontinued | 20 Nov 1979 |
| TOLBUTAMIDE | 500MG | tablet · oral | DAVA PHARMS INC | Discontinued | 5 Feb 1980 |
| TOLBUTAMIDE | 500MG | tablet · oral | ANI PHARMS | Discontinued | 25 Mar 1980 |
| TOLBUTAMIDE | 500MG | tablet · oral | CHARTWELL RX | Discontinued | 4 Jun 1980 |
| TOLBUTAMIDE | 500MG | tablet · oral | BARR | Discontinued | 20 Feb 1981 |
| TOLBUTAMIDE | 500MG | tablet · oral | WATSON LABS | Discontinued | 31 Mar 1981 |
| TOLBUTAMIDE | 500MG | tablet · oral | SUPERPHARM | Discontinued | 19 Nov 1984 |
| TOLBUTAMIDE | 500MG | tablet · oral | ASCOT | Discontinued | |
| TOLBUTAMIDE | 500MG | tablet · oral | VANGARD | Discontinued | |
| TOLBUTAMIDE | 500MG | tablet · oral | PUREPAC PHARM | Discontinued | |
| TOLBUTAMIDE | 250MG | tablet · oral | WATSON LABS | Discontinued | |
| TOLBUTAMIDE | 500MG | tablet · oral | WATSON LABS | Discontinued |
UK MHRA United Kingdom — marketing authorisations
| Product | Authorisation | Holder | Legal status |
|---|---|---|---|
| GLYCONON | PL 33414/0114 | CHELONIA HEALTHCARE LIMITED | POM |
| TOLBUTAMIDE 500MG TABLETS | PL 08215/0007 | KENT PHARMACEUTICALS LIMITED | POM |
| TOLBUTAMIDE 500MG TABLETS | PL 42976/0062 | GENETHICS EUROPE LIMITED | POM |
| TOLBUTAMIDE TABLETS 500MG | PL 33414/0114 | CHELONIA HEALTHCARE LIMITED | POM |
| TOLBUTAMIDE TABLETS BP 500MG | PL 00142/0378 | ACCORD-UK LIMITED | POM |
| TOLBUTAMIDE TABLETS BP 500MG | PL 06464/0212 | WAYMADE PLC | POM |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| NHS Drug Tariff | Tolbutamide 500mg tablets | £84.00 | 28 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.
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), MHRA category lists of UK marketing authorisations (Open Government Licence v3.0), 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.