Assyro AI

FDA Orange Book · active-ingredient family

Hydrochlorothiazide

Hydrochlorothiazide is approved as 5 brand and 98 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:INZIRQO · NDA 219141

5

Brand (NDA)

98

Generics (ANDA)

1

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule, for suspension, solution, tablet

ProductApplicantApplicationTEApproved
INZIRQORLDNOVITIUM PHARMANDA 219141—Jan 28, 2025
MICROZIDERLDTEVA BRANDED PHARMNDA 020504ABDec 27, 1996
HYDRODIURILRLD×3MERCKNDA 011835—Approved Prior to Jan 1, 1982
ESIDRIX×3NOVARTISNDA 011793—Approved Prior to Jan 1, 1982
ORETIC×2ABBVIENDA 011971—Approved Prior to Jan 1, 1982

Generic (ANDA) products (98)

ProductApplicantApplicationTEApproved
HYDROCHLOROTHIAZIDE×3UNICHEMANDA 040907ABApr 03, 2025
HYDROCHLOROTHIAZIDERLD×3IVAX SUB TEVA PHARMSANDA 083177ABSep 19, 2024
HYDROCHLOROTHIAZIDE×3HERITAGEANDA 085182ABMay 02, 2023
HYDROCHLOROTHIAZIDESCIEGEN PHARMSANDA 203561ABJan 14, 2019
HYDROCHLOROTHIAZIDE×3LEADINGANDA 040702ABMay 10, 2017
HYDROCHLOROTHIAZIDE×2SCIEGEN PHARMSANDA 203018ABJul 23, 2014
HYDROCHLOROTHIAZIDESUN PHARM INDS INCANDA 090651—Apr 07, 2014
HYDROCHLOROTHIAZIDE×3ACCORD HLTHCAREANDA 202556ABSep 24, 2012
HYDROCHLOROTHIAZIDECHARTWELL MOLECULARANDA 091662—Jan 27, 2012
HYDROCHLOROTHIAZIDEALEMBIC PHARMS LTDANDA 200645—Nov 30, 2010
HYDROCHLOROTHIAZIDEUNICHEMANDA 090510ABJan 19, 2010
HYDROCHLOROTHIAZIDEIPCA LABS LTDANDA 079237—Apr 02, 2009
HYDROCHLOROTHIAZIDESUN PHARM INDS INCANDA 040857—May 30, 2008
HYDROCHLOROTHIAZIDEAPOTEXANDA 078389—May 16, 2008
HYDROCHLOROTHIAZIDEJUBILANT CADISTAANDA 078391ABFeb 11, 2008
HYDROCHLOROTHIAZIDEHIKMA INTL PHARMSANDA 077885—Nov 26, 2007
HYDROCHLOROTHIAZIDE×2APOTEXANDA 040774—Oct 03, 2007
HYDROCHLOROTHIAZIDEAUROBINDO PHARMAANDA 078164ABSep 18, 2007
HYDROCHLOROTHIAZIDE×2JUBILANT CADISTAANDA 040809—Sep 04, 2007
HYDROCHLOROTHIAZIDE×2AUROBINDO PHARMAANDA 040780ABJul 20, 2007
HYDROCHLOROTHIAZIDE×3IPCA LABS LTDANDA 040807—Jul 20, 2007
HYDROCHLOROTHIAZIDE×2SUN PHARM INDS INCANDA 040810—Mar 27, 2007
HYDROCHLOROTHIAZIDEACTAVIS ELIZABETHANDA 040707ABFeb 27, 2007
HYDROCHLOROTHIAZIDEPHARMOBEDIENTANDA 040770—Jan 23, 2007
HYDROCHLOROTHIAZIDE×2PHARMOBEDIENTANDA 040735—Jan 23, 2007
HYDROCHLOROTHIAZIDE×2HIKMA INTL PHARMSANDA 084878—Jul 12, 2006
HYDROCHLOROTHIAZIDEIVAX SUB TEVA PHARMSANDA 077005—Jul 13, 2005
HYDROCHLOROTHIAZIDEPRINSTON INCANDA 075907ABSep 17, 2002
HYDROCHLOROTHIAZIDE×2PRINSTON INCANDA 040412—Mar 29, 2002
HYDROCHLOROTHIAZIDEQUAGENANDA 075640—Jan 28, 2000
HYDROCHLOROTHIAZIDEWATSON LABSANDA 081189—Jan 24, 1992
HYDROCHLOROTHIAZIDEWATSON LABSANDA 081190—Jan 24, 1992
HYDROCHLOROTHIAZIDEMORTON GROVEANDA 089661—Jun 20, 1988
HYDROCHLOROTHIAZIDETEVAANDA 088924—Feb 07, 1985
HYDROCHLOROTHIAZIDETEVAANDA 088923—Feb 07, 1985
HYDROCHLOROTHIAZIDESUPERPHARMANDA 088827—Dec 28, 1984
HYDROCHLOROTHIAZIDESUPERPHARMANDA 088828—Dec 28, 1984
HYDROCHLOROTHIAZIDESUPERPHARMANDA 088829—Dec 28, 1984
HYDROCHLOROTHIAZIDERLDROXANEANDA 088587—Jul 02, 1984
HYDROCHLOROTHIAZIDE INTENSOLROXANEANDA 088588—Jul 02, 1984
HYDROCHLOROTHIAZIDEWARNER CHILCOTTANDA 087586—May 03, 1982
HYDROCHLOROTHIAZIDEWARNER CHILCOTTANDA 087587—May 03, 1982
HYDROCHLOROTHIAZIDEUSL PHARMAANDA 087827—Apr 19, 1982
HYDROCHLOROTHIAZIDEUSL PHARMAANDA 087752—Apr 19, 1982
HYDROCHLOROTHIAZIDECHARTWELL RXANDA 087565—Mar 09, 1982
HYDROCHLOROTHIAZIDEASCOTANDA 087539—Feb 03, 1982
HYDROCHLOROTHIAZIDEASCOTANDA 087540—Feb 03, 1982
HYDRO-DHALSEYANDA 086504—Approved Prior to Jan 1, 1982
HYDRO-DHALSEYANDA 083891—Approved Prior to Jan 1, 1982
HYDROCHLOROTHIAZIDEABC HOLDINGANDA 085672—Approved Prior to Jan 1, 1982
HYDROCHLOROTHIAZIDEACTAVIS ELIZABETHANDA 085054—Approved Prior to Jan 1, 1982
HYDROCHLOROTHIAZIDEACTAVIS ELIZABETHANDA 085208—Approved Prior to Jan 1, 1982
HYDROCHLOROTHIAZIDEALRAANDA 086369—Approved Prior to Jan 1, 1982
HYDROCHLOROTHIAZIDEALRAANDA 083554—Approved Prior to Jan 1, 1982
HYDROCHLOROTHIAZIDEAUROLIFE PHARMA LLCANDA 083899—Approved Prior to Jan 1, 1982
HYDROCHLOROTHIAZIDEAUROLIFE PHARMA LLCANDA 085219—Approved Prior to Jan 1, 1982
HYDROCHLOROTHIAZIDEBARRANDA 084771—Approved Prior to Jan 1, 1982
HYDROCHLOROTHIAZIDECHARTWELL RXANDA 085683—Approved Prior to Jan 1, 1982
HYDROCHLOROTHIAZIDECHARTWELL RXANDA 083965—Approved Prior to Jan 1, 1982
HYDROCHLOROTHIAZIDECHARTWELL RXANDA 084912—Approved Prior to Jan 1, 1982
HYDROCHLOROTHIAZIDEDAVA PHARMS INCANDA 087060—Approved Prior to Jan 1, 1982
HYDROCHLOROTHIAZIDEELKINS SINNANDA 085152—Approved Prior to Jan 1, 1982
HYDROCHLOROTHIAZIDEHEATHERANDA 084135—Approved Prior to Jan 1, 1982
HYDROCHLOROTHIAZIDEIMPAX LABSANDA 084029—Approved Prior to Jan 1, 1982
HYDROCHLOROTHIAZIDEIMPAX LABSANDA 083607—Approved Prior to Jan 1, 1982
HYDROCHLOROTHIAZIDEIMPAX LABSANDA 085098—Approved Prior to Jan 1, 1982
HYDROCHLOROTHIAZIDE×2INWOOD LABSANDA 084776—Approved Prior to Jan 1, 1982
HYDROCHLOROTHIAZIDEINWOOD LABSANDA 085067—Approved Prior to Jan 1, 1982
HYDROCHLOROTHIAZIDEIVAX SUB TEVA PHARMSANDA 084658—Approved Prior to Jan 1, 1982
HYDROCHLOROTHIAZIDERLDIVAX SUB TEVA PHARMSANDA 085022—Approved Prior to Jan 1, 1982
HYDROCHLOROTHIAZIDELANNETT CO INCANDA 084325—Approved Prior to Jan 1, 1982
HYDROCHLOROTHIAZIDELANNETT CO INCANDA 084324—Approved Prior to Jan 1, 1982
HYDROCHLOROTHIAZIDE×2MAST MMANDA 086192—Approved Prior to Jan 1, 1982
HYDROCHLOROTHIAZIDEMYLANANDA 084880—Approved Prior to Jan 1, 1982
HYDROCHLOROTHIAZIDEMYLANANDA 085112—Approved Prior to Jan 1, 1982
HYDROCHLOROTHIAZIDEOXFORD PHARMSANDA 087059ABApproved Prior to Jan 1, 1982
HYDROCHLOROTHIAZIDEOXFORD PHARMSANDA 087068ABApproved Prior to Jan 1, 1982
HYDROCHLOROTHIAZIDEPVT FORMANDA 086597—Approved Prior to Jan 1, 1982
HYDROCHLOROTHIAZIDEROXANEANDA 085004—Approved Prior to Jan 1, 1982
HYDROCHLOROTHIAZIDEROXANEANDA 084536—Approved Prior to Jan 1, 1982
HYDROCHLOROTHIAZIDEROXANEANDA 085005—Approved Prior to Jan 1, 1982
HYDROCHLOROTHIAZIDESOLVAYANDA 085323—Approved Prior to Jan 1, 1982
HYDROCHLOROTHIAZIDE×3SUN PHARM INDUSTRIESANDA 083972—Approved Prior to Jan 1, 1982
HYDROCHLOROTHIAZIDEVANGARDANDA 087638—Approved Prior to Jan 1, 1982
HYDROCHLOROTHIAZIDEVANGARDANDA 087610—Approved Prior to Jan 1, 1982
HYDROCHLOROTHIAZIDEWATSON LABSANDA 083458—Approved Prior to Jan 1, 1982
HYDROCHLOROTHIAZIDEWATSON LABSANDA 085232—Approved Prior to Jan 1, 1982
HYDROCHLOROTHIAZIDEWATSON LABSANDA 083456—Approved Prior to Jan 1, 1982
HYDROCHLOROTHIAZIDEWATSON LABSANDA 085233—Approved Prior to Jan 1, 1982
HYDROCHLOROTHIAZIDEWATSON LABSANDA 086087—Approved Prior to Jan 1, 1982
HYDROCHLOROTHIAZIDEWATSON LABSANDA 086594—Approved Prior to Jan 1, 1982
HYDROCHLOROTHIAZIDEWATSON LABSANDA 085099—Approved Prior to Jan 1, 1982
HYDROCHLOROTHIAZIDEWATSON LABSANDA 087002—Approved Prior to Jan 1, 1982
HYDROCHLOROTHIAZIDEWATSON LABS TEVAANDA 083232—Approved Prior to Jan 1, 1982
HYDROCHLOROTHIAZIDEWEST WARDANDA 084899—Approved Prior to Jan 1, 1982
HYDROCHLOROTHIAZIDE×2WHITEWORTH TOWN PLSNANDA 083809—Approved Prior to Jan 1, 1982
HYDROCHLOROTHIAZIDEWHITEWORTH TOWN PLSNANDA 085347—Approved Prior to Jan 1, 1982
ZIDESOLVAYANDA 083925—Approved Prior to Jan 1, 1982

Listed patents (1)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
11878022Jan 23, 2044in 17 yr 10 mo
ProductU-4138

Hydrochlorothiazide — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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