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Active ingredient

Bumetanide

129 finished FDA listings contain Bumetanide as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
BUMETANIDE
Dosage forms
Injection, Injection, Solution, Spray, Tablet
Routes
Intramuscular, Intravenous, Nasal, Oral
Manufacturers / labelers
41
Strengths listed
.25 mg/ml · .5 mg/.1ml · .5 mg/1 · 1 mg/1 · 2 mg/1
Brand names in FDA listings
Bumex, Enbumyst

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 1808

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 018225VALIDUS PHARMS1983-02-288
ANDA 074441SAGENT1995-01-273
ANDA 074225HERITAGE PHARMA1995-04-246
ANDA 074700SANDOZ1996-11-2120
ANDA 079196WEST-WARD PHARMS INT2008-04-308
ANDA 209724AMNEAL PHARMS CO2017-10-1812
ANDA 209916UPSHER SMITH LABS2018-01-234
ANDA 202900ZYDUS PHARMS2018-04-309
ANDA 212019RISING2019-12-124
ANDA 216434GLAND2022-05-266
ANDA 215364MSN2022-08-045
ANDA 213458TARO2023-07-243
ANDA 217153LUPIN2024-09-171
ANDA 212931APPCO2024-09-188
ANDA 219116QILU PHARM HAINAN2024-09-194
ANDA 213942RUBICON RESEARCH2024-12-2712
ANDA 218746ASPIRO2025-02-272
ANDA 219291MANKIND PHARMA2025-04-038
NDA 219500CORSTASIS THERAP2025-09-121
ANDA 215362MSN2026-02-053
ANDA 220427ADAPTIS2026-02-262

Official labeling on DailyMed

Showing the 12 most recent of 73 labels.

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