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Active ingredient

Hydrochlorothiazide

169 finished FDA listings contain Hydrochlorothiazide as their only active ingredient; 720 combination products also contain it.

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FDA NDC Directory

Ingredient names as written by FDA
HYDROCHLOROTHIAZIDE
Dosage forms
Capsule, Capsule, Gelatin Coated, Powder, For Suspension, Tablet
Routes
Oral
Manufacturers / labelers
45
Strengths listed
10 mg/ml · 12.5 mg/1 · 25 mg/1 · 50 mg/1
Brand names in FDA listings
Inzirqo

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 5487

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 083177IVAX SUB TEVA PHARMS1973-01-1217
ANDA 085182HERITAGE1978-01-2019
ANDA 087059OXFORD PHARMS1980-11-059
ANDA 087068OXFORD PHARMS1980-11-053
NDA 020504TEVA BRANDED PHARM1996-12-274
ANDA 040412PRINSTON INC2002-03-299
ANDA 040707ACTAVIS ELIZABETH2007-02-273
ANDA 040702LEADING2007-03-1622
ANDA 040780AUROBINDO PHARMA2007-07-202
ANDA 078164AUROBINDO PHARMA2007-09-194
ANDA 040907UNICHEM2008-08-1526
ANDA 090510UNICHEM2010-01-199
ANDA 200645ALEMBIC PHARMS LTD2010-11-302
ANDA 202556ACCORD HLTHCARE2012-09-2420
ANDA 203018SCIEGEN PHARMS2014-07-232
ANDA 203561SCIEGEN PHARMS2019-01-1417
NDA 219141NOVITIUM PHARMA2025-01-281

Official labeling on DailyMed

Showing the 12 most recent of 139 labels.

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