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Sold as Florinef. Every FDA application for this active ingredient: 1 branded and 7 generic.
As of Nov 15, 2026, FDA lists 8 applications for Fludrocortisone Acetate (sold as Florinef), first approved Aug 18, 1955, with 0 new uses approved and 0 published complete response letters.
First approved: Aug 18, 1955
Applications: 8
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $12.3M
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
Product
Part
Spending, 2025
Change
Beneficiaries
Fludrocortisone Acetate
Part D
$12.3M
+3%
124,919
What Pharmacies Pay
Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change
FLUDROCORTISONE 0.1 MG TABLET: $0.316 per unitGeneric · -10% in a year
Clinical Trials
22 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA
Impax Labs
Novitium Pharma
Zydus Lifesciences