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Active ingredient

Metolazone

62 finished FDA listings contain Metolazone as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
METOLAZONE
Dosage forms
Tablet
Routes
Oral
Manufacturers / labelers
19
Strengths listed
10 mg/1 · 2.5 mg/1 · 5 mg/1

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 6916

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 076466SANDOZ2003-12-196
ANDA 076732SANDOZ2003-12-194
ANDA 076698MYLAN2003-12-239
ANDA 213251ALEMBIC2020-12-026
ANDA 214799UNICHEM2021-03-303
ANDA 213827INNOGENIX2021-03-3019
ANDA 215184RUBICON RESEARCH2021-08-204
ANDA 215616RENATA2022-10-245
ANDA 216216NE RX PHARMA2022-10-256

Official labeling on DailyMed

Showing the 12 most recent of 30 labels.

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