Is there a generic for Hydrochlorothiazide?

Yes. The FDA Orange Book lists 98 approved generic (ANDA) applications for Hydrochlorothiazide, referencing the brand INZIRQO. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Hydrochlorothiazide?

INZIRQO (NDA 219141, NOVITIUM PHARMA) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Hydrochlorothiazide?

The Orange Book lists 1 patent against Hydrochlorothiazide products, with the earliest listed expiry in 2044. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Hydrochlorothiazide are approved?

Hydrochlorothiazide is approved in the following dosage forms: capsule, for suspension, solution, tablet.

FDA Orange Book · active-ingredient family

Hydrochlorothiazide

Hydrochlorothiazide: 5 brands, 98 generics; first approved Feb 03, 1982; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 98 ANDA applications approved.

Earliest patent expiry Jan 23, 2044

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Jan 23, 2044

in 17 yr 6 mo

Brand (NDA) products

Originator applications

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INZIRQORLDRS
NOVITIUM PHARMANDA 2191412025
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/ML FOR SUSPENSION ORAL Rx -
MICROZIDERLDRS
TEVA BRANDED PHARMNDA 0205041996
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
12.5MG CAPSULE ORAL Rx AB
HYDRODIURILRLD
MERCKNDA 011835-3 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Discontinued -
50MG TABLET ORAL Discontinued -
100MG TABLET ORAL Discontinued -
ESIDRIX
NOVARTISNDA 011793-3 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Discontinued -
50MG TABLET ORAL Discontinued -
100MG TABLET ORAL Discontinued -
ORETIC
ABBVIENDA 011971-2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Discontinued -
50MG TABLET ORAL Discontinued -

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/ML	FOR SUSPENSION	ORAL	Rx	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
12.5MG	CAPSULE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET	ORAL	Discontinued	-
50MG	TABLET	ORAL	Discontinued	-
100MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET	ORAL	Discontinued	-
50MG	TABLET	ORAL	Discontinued	-
100MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET	ORAL	Discontinued	-
50MG	TABLET	ORAL	Discontinued	-

Generic (ANDA) products (98)

Abbreviated applications

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HYDROCHLOROTHIAZIDE
UNICHEMANDA 04090720253 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Rx AB
50MG TABLET ORAL Rx AB
12.5MG TABLET ORAL Rx AB
HYDROCHLOROTHIAZIDERLD
IVAX SUB TEVA PHARMSANDA 08317720243 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Rx AB
50MG TABLET ORAL Rx AB
12.5MG TABLET ORAL Rx AB
HYDROCHLOROTHIAZIDE
HERITAGEANDA 08518220233 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG TABLET ORAL Rx AB
25MG TABLET ORAL Rx AB
12.5MG TABLET ORAL Rx AB
HYDROCHLOROTHIAZIDE
SCIEGEN PHARMSANDA 2035612019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
12.5MG CAPSULE ORAL Rx AB
HYDROCHLOROTHIAZIDE
LEADINGANDA 04070220173 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Rx AB
50MG TABLET ORAL Rx AB
12.5MG TABLET ORAL Rx AB
HYDROCHLOROTHIAZIDE
SCIEGEN PHARMSANDA 20301820142 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Rx AB
50MG TABLET ORAL Rx AB
HYDROCHLOROTHIAZIDE
SUN PHARM INDS INCANDA 0906512014
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
12.5MG CAPSULE ORAL Discontinued -
HYDROCHLOROTHIAZIDE
ACCORD HLTHCAREANDA 20255620123 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
12.5MG TABLET ORAL Rx AB
25MG TABLET ORAL Rx AB
50MG TABLET ORAL Rx AB
HYDROCHLOROTHIAZIDE
CHARTWELL MOLECULARANDA 0916622012
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
12.5MG CAPSULE ORAL Discontinued -
HYDROCHLOROTHIAZIDE
ALEMBIC PHARMS LTDANDA 2006452010
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
12.5MG CAPSULE ORAL Discontinued -
HYDROCHLOROTHIAZIDE
UNICHEMANDA 0905102010
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
12.5MG CAPSULE ORAL Rx AB
HYDROCHLOROTHIAZIDE
IPCA LABS LTDANDA 0792372009
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
12.5MG CAPSULE ORAL Discontinued -
HYDROCHLOROTHIAZIDE
SUN PHARM INDS INCANDA 0408572008
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
12.5MG TABLET ORAL Discontinued -
HYDROCHLOROTHIAZIDE
APOTEXANDA 0783892008
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
12.5MG CAPSULE ORAL Discontinued -
HYDROCHLOROTHIAZIDE
JUBILANT CADISTAANDA 0783912008
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
12.5MG CAPSULE ORAL Rx AB
HYDROCHLOROTHIAZIDE
HIKMA INTL PHARMSANDA 0778852007
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
12.5MG CAPSULE ORAL Discontinued -
HYDROCHLOROTHIAZIDE
APOTEXANDA 04077420072 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Discontinued -
50MG TABLET ORAL Discontinued -
HYDROCHLOROTHIAZIDE
AUROBINDO PHARMAANDA 0781642007
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
12.5MG CAPSULE ORAL Rx AB
HYDROCHLOROTHIAZIDE
JUBILANT CADISTAANDA 04080920072 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Discontinued -
50MG TABLET ORAL Discontinued -
HYDROCHLOROTHIAZIDE
AUROBINDO PHARMAANDA 04078020072 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Rx AB
50MG TABLET ORAL Rx AB
HYDROCHLOROTHIAZIDE
IPCA LABS LTDANDA 04080720073 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
12.5MG TABLET ORAL Discontinued -
25MG TABLET ORAL Discontinued -
50MG TABLET ORAL Discontinued -
HYDROCHLOROTHIAZIDE
SUN PHARM INDS INCANDA 04081020072 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Discontinued -
50MG TABLET ORAL Discontinued -
HYDROCHLOROTHIAZIDE
ACTAVIS ELIZABETHANDA 0407072007
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
12.5MG TABLET ORAL Rx AB
HYDROCHLOROTHIAZIDE
PHARMOBEDIENTANDA 0407702007
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
12.5MG TABLET ORAL Discontinued -
HYDROCHLOROTHIAZIDE
PHARMOBEDIENTANDA 04073520072 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Discontinued -
50MG TABLET ORAL Discontinued -
HYDROCHLOROTHIAZIDE
HIKMA INTL PHARMSANDA 08487820062 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG TABLET ORAL Discontinued -
25MG TABLET ORAL Discontinued -
HYDROCHLOROTHIAZIDE
IVAX SUB TEVA PHARMSANDA 0770052005
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
12.5MG CAPSULE ORAL Discontinued -
HYDROCHLOROTHIAZIDE
PRINSTON INCANDA 0759072002
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
12.5MG CAPSULE ORAL Rx AB
HYDROCHLOROTHIAZIDE
PRINSTON INCANDA 04041220022 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Discontinued -
50MG TABLET ORAL Discontinued -
HYDROCHLOROTHIAZIDE
QUAGENANDA 0756402000
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
12.5MG CAPSULE ORAL Discontinued -
HYDROCHLOROTHIAZIDE
WATSON LABSANDA 0811891992
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Discontinued -
HYDROCHLOROTHIAZIDE
WATSON LABSANDA 0811901992
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG TABLET ORAL Discontinued -
HYDROCHLOROTHIAZIDE
MORTON GROVEANDA 0896611988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG/5ML SOLUTION ORAL Discontinued -
HYDROCHLOROTHIAZIDE
TEVAANDA 0889241985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Discontinued -
HYDROCHLOROTHIAZIDE
TEVAANDA 0889231985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG TABLET ORAL Discontinued -
HYDROCHLOROTHIAZIDE
SUPERPHARMANDA 0888271984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Discontinued -
HYDROCHLOROTHIAZIDE
SUPERPHARMANDA 0888281984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG TABLET ORAL Discontinued -
HYDROCHLOROTHIAZIDE
SUPERPHARMANDA 0888291984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG TABLET ORAL Discontinued -
HYDROCHLOROTHIAZIDERLD
ROXANEANDA 0885871984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG/5ML SOLUTION ORAL Discontinued -
HYDROCHLOROTHIAZIDE INTENSOL
ROXANEANDA 0885881984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG/ML SOLUTION ORAL Discontinued -
HYDROCHLOROTHIAZIDE
WARNER CHILCOTTANDA 0875861982
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Discontinued -
HYDROCHLOROTHIAZIDE
WARNER CHILCOTTANDA 0875871982
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG TABLET ORAL Discontinued -
HYDROCHLOROTHIAZIDE
USL PHARMAANDA 0878271982
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Discontinued -
HYDROCHLOROTHIAZIDE
USL PHARMAANDA 0877521982
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG TABLET ORAL Discontinued -
HYDROCHLOROTHIAZIDE
CHARTWELL RXANDA 0875651982
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Discontinued -
HYDROCHLOROTHIAZIDE
ASCOTANDA 0875391982
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Discontinued -
HYDROCHLOROTHIAZIDE
ASCOTANDA 0875401982
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG TABLET ORAL Discontinued -
HYDRO-D
HALSEYANDA 086504-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Discontinued -
HYDRO-D
HALSEYANDA 083891-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG TABLET ORAL Discontinued -
HYDROCHLOROTHIAZIDE
ABC HOLDINGANDA 085672-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG TABLET ORAL Discontinued -
HYDROCHLOROTHIAZIDE
ACTAVIS ELIZABETHANDA 085054-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Discontinued -
HYDROCHLOROTHIAZIDE
ACTAVIS ELIZABETHANDA 085208-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG TABLET ORAL Discontinued -
HYDROCHLOROTHIAZIDE
ALRAANDA 086369-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Discontinued -
HYDROCHLOROTHIAZIDE
ALRAANDA 083554-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG TABLET ORAL Discontinued -
HYDROCHLOROTHIAZIDE
AUROLIFE PHARMA LLCANDA 083899-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Discontinued -
HYDROCHLOROTHIAZIDE
AUROLIFE PHARMA LLCANDA 085219-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG TABLET ORAL Discontinued -
HYDROCHLOROTHIAZIDE
BARRANDA 084771-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG TABLET ORAL Discontinued -
HYDROCHLOROTHIAZIDE
CHARTWELL RXANDA 085683-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Discontinued -
HYDROCHLOROTHIAZIDE
CHARTWELL RXANDA 083965-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG TABLET ORAL Discontinued -
HYDROCHLOROTHIAZIDE
CHARTWELL RXANDA 084912-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG TABLET ORAL Discontinued -
HYDROCHLOROTHIAZIDE
DAVA PHARMS INCANDA 087060-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG TABLET ORAL Discontinued -
HYDROCHLOROTHIAZIDE
ELKINS SINNANDA 085152-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG TABLET ORAL Discontinued -
HYDROCHLOROTHIAZIDE
HEATHERANDA 084135-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG TABLET ORAL Discontinued -
HYDROCHLOROTHIAZIDE
IMPAX LABSANDA 084029-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Discontinued -
HYDROCHLOROTHIAZIDE
IMPAX LABSANDA 083607-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG TABLET ORAL Discontinued -
HYDROCHLOROTHIAZIDE
IMPAX LABSANDA 085098-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG TABLET ORAL Discontinued -
HYDROCHLOROTHIAZIDE
INWOOD LABSANDA 084776-2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Discontinued -
50MG TABLET ORAL Discontinued -
HYDROCHLOROTHIAZIDE
INWOOD LABSANDA 085067-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Discontinued -
HYDROCHLOROTHIAZIDE
IVAX SUB TEVA PHARMSANDA 084658-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG TABLET ORAL Discontinued -
HYDROCHLOROTHIAZIDERLD
IVAX SUB TEVA PHARMSANDA 085022-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG TABLET ORAL Discontinued -
HYDROCHLOROTHIAZIDE
LANNETT CO INCANDA 084325-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Discontinued -
HYDROCHLOROTHIAZIDE
LANNETT CO INCANDA 084324-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG TABLET ORAL Discontinued -
HYDROCHLOROTHIAZIDE
MAST MMANDA 086192-2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Discontinued -
50MG TABLET ORAL Discontinued -
HYDROCHLOROTHIAZIDE
MYLANANDA 084880-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Discontinued -
HYDROCHLOROTHIAZIDE
MYLANANDA 085112-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG TABLET ORAL Discontinued -
HYDROCHLOROTHIAZIDE
OXFORD PHARMSANDA 087059-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Rx AB
HYDROCHLOROTHIAZIDE
OXFORD PHARMSANDA 087068-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG TABLET ORAL Rx AB
HYDROCHLOROTHIAZIDE
PVT FORMANDA 086597-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG TABLET ORAL Discontinued -
HYDROCHLOROTHIAZIDE
ROXANEANDA 085004-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Discontinued -
HYDROCHLOROTHIAZIDE
ROXANEANDA 084536-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG TABLET ORAL Discontinued -
HYDROCHLOROTHIAZIDE
ROXANEANDA 085005-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG TABLET ORAL Discontinued -
HYDROCHLOROTHIAZIDE
SOLVAYANDA 085323-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Discontinued -
HYDROCHLOROTHIAZIDE
SUN PHARM INDUSTRIESANDA 083972-3 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Discontinued -
50MG TABLET ORAL Discontinued -
100MG TABLET ORAL Discontinued -
HYDROCHLOROTHIAZIDE
VANGARDANDA 087638-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Discontinued -
HYDROCHLOROTHIAZIDE
VANGARDANDA 087610-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG TABLET ORAL Discontinued -
HYDROCHLOROTHIAZIDE
WATSON LABSANDA 083458-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Discontinued -
HYDROCHLOROTHIAZIDE
WATSON LABSANDA 085232-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Discontinued -
HYDROCHLOROTHIAZIDE
WATSON LABSANDA 083456-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG TABLET ORAL Discontinued -
HYDROCHLOROTHIAZIDE
WATSON LABSANDA 085233-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG TABLET ORAL Discontinued -
HYDROCHLOROTHIAZIDE
WATSON LABSANDA 086087-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG TABLET ORAL Discontinued -
HYDROCHLOROTHIAZIDE
WATSON LABSANDA 086594-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG TABLET ORAL Discontinued -
HYDROCHLOROTHIAZIDE
WATSON LABSANDA 085099-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG TABLET ORAL Discontinued -
HYDROCHLOROTHIAZIDE
WATSON LABSANDA 087002-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG TABLET ORAL Discontinued -
HYDROCHLOROTHIAZIDE
WATSON LABS TEVAANDA 083232-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG TABLET ORAL Discontinued -
HYDROCHLOROTHIAZIDE
WEST WARDANDA 084899-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Discontinued -
HYDROCHLOROTHIAZIDE
WHITEWORTH TOWN PLSNANDA 083809-2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG TABLET ORAL Discontinued -
25MG TABLET ORAL Discontinued -
HYDROCHLOROTHIAZIDE
WHITEWORTH TOWN PLSNANDA 085347-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG TABLET ORAL Discontinued -
ZIDE
SOLVAYANDA 083925-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG TABLET ORAL Discontinued -

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET	ORAL	Rx	AB
50MG	TABLET	ORAL	Rx	AB
12.5MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET	ORAL	Rx	AB
50MG	TABLET	ORAL	Rx	AB
12.5MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG	TABLET	ORAL	Rx	AB
25MG	TABLET	ORAL	Rx	AB
12.5MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
12.5MG	CAPSULE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET	ORAL	Rx	AB
50MG	TABLET	ORAL	Rx	AB
12.5MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET	ORAL	Rx	AB
50MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
12.5MG	CAPSULE	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
12.5MG	TABLET	ORAL	Rx	AB
25MG	TABLET	ORAL	Rx	AB
50MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
12.5MG	CAPSULE	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
12.5MG	CAPSULE	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
12.5MG	CAPSULE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
12.5MG	CAPSULE	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
12.5MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
12.5MG	CAPSULE	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
12.5MG	CAPSULE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
12.5MG	CAPSULE	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET	ORAL	Discontinued	-
50MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
12.5MG	CAPSULE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET	ORAL	Discontinued	-
50MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET	ORAL	Rx	AB
50MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
12.5MG	TABLET	ORAL	Discontinued	-
25MG	TABLET	ORAL	Discontinued	-
50MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET	ORAL	Discontinued	-
50MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
12.5MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
12.5MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET	ORAL	Discontinued	-
50MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG	TABLET	ORAL	Discontinued	-
25MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
12.5MG	CAPSULE	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
12.5MG	CAPSULE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET	ORAL	Discontinued	-
50MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
12.5MG	CAPSULE	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG/5ML	SOLUTION	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG/5ML	SOLUTION	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG/ML	SOLUTION	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET	ORAL	Discontinued	-

Patent & exclusivity timeline

Protection horizon

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Patent expiryExclusivity endToday

Listed patents

Orange Book patent file

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Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
11878022	Jan 23, 2044	in 17 yr 6 mo	ProductU-4138

Approval history

FDA approval span

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First approval

Feb 03, 1982

45 yr 4 mo ago

Most recent approval

Apr 03, 2025

1 yr 7 mo ago

Approvals span 1982–2025 across 103 FDA applications.

Brand (NDA) 55%

Generic (ANDA) 9895%

Hydrochlorothiazide: frequently asked questions

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

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Related FDA reference tools

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