Active substance
Fludrocortisone
- US FDA 8
- UK MHRA 12
- US price lines 1
- NHS prices 3
- WHO EML 1
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| FLUDROCORTISONE ACETATE | 0.1MG | tablet · oral | IMPAX LABS | Prescription | 18 Mar 2002 |
| FLUDROCORTISONE ACETATE | 0.1MG | tablet · oral | NOVITIUM PHARMA | Prescription | 31 May 2022 |
| FLUDROCORTISONE ACETATE | 0.1MG | tablet · oral | ZYDUS LIFESCIENCES | Prescription | 16 Oct 2024 |
| FLUDROCORTISONE ACETATE | 0.1MG | tablet · oral | ADAPTIS | Prescription | 10 Feb 2026 |
| FLORINEF | 0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | tablet · oral | CASPER PHARMA LLC | Discontinued | 18 Aug 1955 |
| FLUDROCORTISONE ACETATE | 0.1MG | tablet · oral | BARR | Discontinued | 21 Jan 2003 |
| FLUDROCORTISONE ACETATE | 0.1MG | tablet · oral | HIKMA PHARMS | Discontinued | 22 Jul 2011 |
| FLUDROCORTISONE ACETATE | 0.1MG | tablet · oral | CHARTWELL RX | Discontinued | 27 Oct 2022 |
UK MHRA United Kingdom — marketing authorisations
| Product | Authorisation | Holder | Legal status |
|---|---|---|---|
| FLUDROCORTISONE ACETATE 0.05 MG TABLETS | PL 35533/0197 | ASPIRE PHARMA LIMITED | POM |
| FLUDROCORTISONE ACETATE 0.05 MG TABLETS | PL 49578/0028 | ROMA PHARMACEUTICALS LIMITED | POM |
| FLUDROCORTISONE ACETATE 0.1 MG TABLETS | PL 04569/1813 | GENERICS (UK) LIMITED | POM |
| FLUDROCORTISONE ACETATE 0.1 MG TABLETS | PL 11311/0676 | TILLOMED LABORATORIES LIMITED | POM |
| FLUDROCORTISONE ACETATE 0.1 MG TABLETS | PL 28444/0257 | ACTIVASE PHARMACEUTICALS LIMITED | POM |
| FLUDROCORTISONE ACETATE 0.1 MG TABLETS | PL 36282/0055 | RIA GENERICS LIMITED | POM |
| FLUDROCORTISONE ACETATE 0.1 MG TABLETS | PL 39699/0071 | ASPEN PHARMA TRADING LIMITED | POM |
| FLUDROCORTISONE ACETATE 0.1 MG TABLETS | PL 42765/0024 | RENATA (UK) LIMITED | POM |
| FLUDROCORTISONE ACETATE 0.1 MG TABLETS | PL 49578/0007 | ROMA PHARMACEUTICALS LIMITED | POM |
| FLUDROCORTISONE ACETATE 0.1 MG/ML ORAL SOLUTION | PL 40546/0228 | ARISTO PHARMA GMBH | POM |
| FLUDROCORTISONE ACETATE 0.1MG TABLETS | PL 00142/1250 | ACCORD-UK LIMITED | POM |
| FLUDROCORTISONE ACETATE 0.1MG TABLETS | PL 48836/0007 | OSGEN PHARMACEUTICALS LIMITED | POM |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | FLUDROCORTISONE 0.1 MG TABLET | $0.3109 | per EA | 23 Sep 2026 |
| NHS Drug Tariff | Fludrocortisone 100microgram tablets | £2.47 | 30 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Fludrocortisone 100micrograms/ml oral solution sugar free | £135.00 | 50 ml | 1 Oct 2026 |
| NHS Drug Tariff | Fludrocortisone 50microgram tablets | £13.60 | 30 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)
- 18.1. Adrenal hormones and synthetic substitutes · core
Adrenocortical insufficiency
Oral > Liquid: 100 µg per mL (EMLc) | Oral > Solid > tablet: 100 µg (acetate)
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.