Quick answers
- What is Fludrocortisone acetate used for?
- The FDA-approved label (Fludrocortisone Acetate, Major Pharmaceuticals, June 24, 2026) says: “Fludrocortisone acetate tablets, 0.1 mg 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.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Fludrocortisone acetate have a boxed warning?
- No. None of the 16 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Fludrocortisone acetate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Fludrocortisone acetate been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Fludrocortisone acetate?
- 15 companies list prescription products of Fludrocortisone acetate in the FDA NDC Directory, including Cardinal Health 107, LLC, NCS HealthCare of KY, LLC dba Vangard Labs and Major Pharmaceuticals.
What Fludrocortisone acetate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Fludrocortisone acetate tablets, 0.1 mg 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.
— FDA label: Fludrocortisone Acetate, Major Pharmaceuticals, effective June 24, 2026. Read the full label on DailyMed →
The FDA has 16 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 16 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet |
|---|---|
| Route | Oral |
| Prescription products | 16 in the FDA NDC Directory |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| fludrocortisone acetate 0.1 mg tablet | Generic | $0.3160 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Cardinal Health 107, LLC2 products
- NCS HealthCare of KY, LLC dba Vangard Labs1 product
- Major Pharmaceuticals1 product
- Amneal Pharmaceuticals NY LLC1 product
- AvKARE1 product
- AvPAK1 product
- American Health Packaging1 product
- Novitium Pharma LLC1 product
- Amneal Pharmaceuticals of New York LLC1 product
- Golden State Medical Supply, Inc.1 product
- Bryant Ranch Prepack1 product
- Viona Pharmaceuticals Inc1 product
- NorthStar Rx LLC1 product
- Zydus Lifesciences Limited1 product
- Eywa Pharma Inc1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (4)
- ANDA040431Impax Labs · March 18, 2002
- ANDA215279Novitium Pharma · May 31, 2022
- ANDA219251Zydus Lifesciences · October 16, 2024
- ANDA220308Adaptis · February 10, 2026
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 313979 |
|---|---|
| SPL set ID of the quoted label | 933e28ef-05e8-419e-a786-21eab67f33a2 |
| FDA labels (SPL) | 16 |
| FDA applications | 4 ANDA |
| Active ingredients (FDA) | FLUDROCORTISONE ACETATE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Fludrocortisone Acetate, Major Pharmaceuticals, effective June 24, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →