Prescription medicine
Fludrocortisone First approved as Florinef
Fludrocortisone (Florinef) is a prescription medicine with an FDA approval on record since 1955. FDA's NDC Directory lists it from 15 generic labelers, and pharmacies paid $0.311 per fludrocortisone 0.1 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the fludrocortisone FDA label on DailyMed (effective October 29, 2024, Zydus Lifesciences Limited); the NDA 10060 record on Drugs@FDA; every fludrocortisone label on DailyMed.
Highlights of the record
FDA label of October 29, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageFludrocortisone acetate tablets are indicated as partial replacement therapy for primary and secondary adrenocortical insufficiency in Addison's disease and for the treatment of salt-losing adrenogenital syndrome.
Forms and strengths
- 0.1 mg
Tablet.
On the market
- Earliest approval on file
- August 18, 1955 Florinef, Casper Pharma Llc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 7 first March 18, 2002; 4 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 15 of which 15 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.311 per tablet Fludrocortisone 0.1 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2024 0 Class I among all firms' recalls; latest June 28, 2024
- FAERS reports
- 2,184 through July 30, 2026
What is fludrocortisone used for?
From the label: indications and usageFludrocortisone acetate tablets are indicated as partial replacement therapy for primary and secondary adrenocortical insufficiency in Addison's disease and for the treatment of salt-losing adrenogenital syndrome.
Source: FDA drug label (Fludrocortisone acetate), Zydus Lifesciences Limited, effective October 29, 2024 (SPL set 6c4a7d2d-00a4-4d80-ab4c-2afd4e4f614e), via openFDA; the full label on DailyMed
Is there a generic for fludrocortisone (Florinef)?
The FDA approved the first generic fludrocortisone on March 18, 2002. 7 generic applications are approved; 4 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists fludrocortisone from 15 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1955 earliest approval on file
- 2002 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for fludrocortisone (Florinef)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.311 per Fludrocortisone 0.1 mg tablet, down 13% from $0.359 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Fludrocortisone 0.1 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Fludrocortisone 0.1 mg tablet | Generic | $0.311 per tablet | $9.33 | -13% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has fludrocortisone been recalled?
The FDA's Enforcement Report lists 1 recall naming fludrocortisone since 2024: 0 Class I (the most serious), 1 Class II, 0 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| June 28, 2024 | Class II | Teva Pharmaceuticals USA, Inc | Failed Impurities/Degradation Specifications: Product is being recalled due to API related substances and unknown impurities that are above the specification … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the fludrocortisone label say about other medicines?
The fludrocortisone label names 8 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name fludrocortisone. 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 |
|---|---|---|
| Amphotericin b | drug interactions | Amphotericin B or potassium-depleting diuretics (benzothiadiazines and related drugs, ethacrynic acid and furosemide)–enhanced hypokalemia. |
| Aspirin | drug interactions | Aspirin –increased ulcerogenic effect; decreased pharmacologic effect of aspirin. |
| Cortisone | warnings | Average and large doses of hydrocortisone or cortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. |
| Ethacrynic acid | drug interactions | Amphotericin B or potassium-depleting diuretics (benzothiadiazines and related drugs, ethacrynic acid and furosemide)–enhanced hypokalemia. |
| Furosemide | drug interactions | Amphotericin B or potassium-depleting diuretics (benzothiadiazines and related drugs, ethacrynic acid and furosemide)–enhanced hypokalemia. |
| Hydrocortisone | warnings | Average and large doses of hydrocortisone or cortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. |
| Phenytoin | drug interactions | Barbiturates, phenytoin, or rifampin –increased metabolic clearance of fludrocortisone acetate because of the induction of hepatic enzymes. |
| Rifampin | drug interactions | Barbiturates, phenytoin, or rifampin –increased metabolic clearance of fludrocortisone acetate because of the induction of hepatic enzymes. |
Other labels that name fludrocortisone
Source: FDA drug label (Fludrocortisone acetate), Zydus Lifesciences Limited, effective October 29, 2024 (SPL set 6c4a7d2d-00a4-4d80-ab4c-2afd4e4f614e), via openFDA; the full label on DailyMed
What do FAERS reports show for fludrocortisone?
The FDA Adverse Event Reporting System holds 2,184 reports that list fludrocortisone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 263 are coded as a death and 867 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Fludrocortisone side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other