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Active ingredient

Fludrocortisone

16 finished FDA listings contain Fludrocortisone as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
FLUDROCORTISONE ACETATE
Dosage forms
Tablet
Routes
Oral
Manufacturers / labelers
15
Strengths listed
.1 mg/1

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 4452

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
ANDA 040431IMPAX LABS2002-03-187
ANDA 215279NOVITIUM PHARMA2022-05-315
ANDA 219251ZYDUS LIFESCIENCES2024-10-163
ANDA 220308ADAPTIS2026-02-101

Official labeling on DailyMed

Showing the 12 most recent of 16 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.