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Active ingredient

Ethacrynate

12 finished FDA listings contain Ethacrynate as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
ETHACRYNATE SODIUM, ETHACRYNIC ACID
Dosage forms
Injection, Powder, For Solution, Injection, Powder, Lyophilized, For Solution, Tablet
Routes
Intravenous, Oral
Manufacturers / labelers
12
Strengths listed
25 mg/1 · 50 mg/50ml
Brand names in FDA listings
Edecrin

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 62349

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
NDA 016092BAUSCH1967-01-102
ANDA 205473PH HEALTH2015-07-291
ANDA 205609ADAPTIS2016-06-301
ANDA 208805AMNEAL PHARMS CO2018-05-081
ANDA 211809AGNITIO2019-07-121
ANDA 211232SCIEGEN PHARMS2019-08-273
ANDA 211719LUPIN2019-09-061
ANDA 212417UPSHER SMITH LABS2020-02-191
ANDA 208663STERIMAX2020-06-091

Official labeling on DailyMed

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