Is there a generic for Hydrochlorothiazide; losartan potassium?

Yes. The FDA Orange Book lists 18 approved generic (ANDA) applications for Hydrochlorothiazide; losartan potassium, referencing the brand HYZAAR. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Hydrochlorothiazide; losartan potassium?

HYZAAR (NDA 020387, ORGANON) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Hydrochlorothiazide; losartan potassium are approved?

Hydrochlorothiazide; losartan potassium is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Hydrochlorothiazide; losartan potassium

Hydrochlorothiazide; losartan potassium: 1 brand, 18 generics; first approved Apr 28, 1995; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 18 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Originator applications

Brand (NDA) products

HYZAARRLD

ORGANONNDA 02038719953 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
12.5MG;50MG	TABLET	ORAL	Rx	AB
25MG;100MG	TABLET	ORAL	Rx	AB
12.5MG;100MG	TABLET	ORAL	Rx	AB

Abbreviated applications

Generic (ANDA) products (18)

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

HETERO LABS LTD VANDA 21986920263 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
12.5MG;50MG	TABLET	ORAL	Rx	AB
12.5MG;100MG	TABLET	ORAL	Rx	AB
25MG;100MG	TABLET	ORAL	Rx	AB

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

GRANULESANDA 21801520233 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
12.5MG;50MG	TABLET	ORAL	Discontinued	—
12.5MG;100MG	TABLET	ORAL	Discontinued	—
25MG;100MG	TABLET	ORAL	Discontinued	—

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

PRINSTON INCANDA 20490120173 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
12.5MG;50MG	TABLET	ORAL	Rx	AB
12.5MG;100MG	TABLET	ORAL	Rx	AB
25MG;100MG	TABLET	ORAL	Rx	AB

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

UNICHEMANDA 20483220173 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
12.5MG;50MG	TABLET	ORAL	Rx	AB
12.5MG;100MG	TABLET	ORAL	Rx	AB
25MG;100MG	TABLET	ORAL	Rx	AB

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

IPCA LABS LTDANDA 20168220133 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
12.5MG;50MG	TABLET	ORAL	Discontinued	—
12.5MG;100MG	TABLET	ORAL	Discontinued	—
25MG;100MG	TABLET	ORAL	Discontinued	—

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

JUBILANT CADISTAANDA 20184520123 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
12.5MG;50MG	TABLET	ORAL	Rx	AB
12.5MG;100MG	TABLET	ORAL	Rx	AB
25MG;100MG	TABLET	ORAL	Rx	AB

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

MACLEODS PHARMS LTDANDA 20228920123 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
12.5MG;50MG	TABLET	ORAL	Rx	AB
12.5MG;100MG	TABLET	ORAL	Rx	AB
25MG;100MG	TABLET	ORAL	Rx	AB

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

ALEMBIC PHARMS LTDANDA 09161720123 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
12.5MG;50MG	TABLET	ORAL	Rx	AB
12.5MG;100MG	TABLET	ORAL	Rx	AB
25MG;100MG	TABLET	ORAL	Rx	AB

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

WATSON LABSANDA 20018020113 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
12.5MG;50MG	TABLET	ORAL	Discontinued	—
12.5MG;100MG	TABLET	ORAL	Discontinued	—
25MG;100MG	TABLET	ORAL	Discontinued	—

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

APOTEXANDA 09015020103 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
12.5MG;50MG	TABLET	ORAL	Discontinued	—
12.5MG;100MG	TABLET	ORAL	Discontinued	—
25MG;100MG	TABLET	ORAL	Discontinued	—

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

AUROBINDO PHARMAANDA 09162920103 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
12.5MG;50MG	TABLET	ORAL	Rx	AB
12.5MG;100MG	TABLET	ORAL	Rx	AB
25MG;100MG	TABLET	ORAL	Rx	AB

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

CHARTWELL RXANDA 07794820103 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
12.5MG;50MG	TABLET	ORAL	Rx	AB
25MG;100MG	TABLET	ORAL	Rx	AB
12.5MG;100MG	TABLET	ORAL	Rx	AB

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

HIKMAANDA 07773220103 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
12.5MG;100MG	TABLET	ORAL	Discontinued	—
12.5MG;50MG	TABLET	ORAL	Discontinued	—
25MG;100MG	TABLET	ORAL	Discontinued	—

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

LUPIN LTDANDA 07824520103 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
12.5MG;50MG	TABLET	ORAL	Rx	AB
12.5MG;100MG	TABLET	ORAL	Rx	AB
25MG;100MG	TABLET	ORAL	Rx	AB

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

MYLANANDA 09165220103 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
12.5MG;50MG	TABLET	ORAL	Discontinued	—
12.5MG;100MG	TABLET	ORAL	Discontinued	—
25MG;100MG	TABLET	ORAL	Discontinued	—

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

TORRENT PHARMSANDA 09052820103 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
12.5MG;50MG	TABLET	ORAL	Discontinued	—
25MG;100MG	TABLET	ORAL	Discontinued	—
12.5MG;100MG	TABLET	ORAL	Discontinued	—

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

ZYDUS PHARMS USA INCANDA 07838520102 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
12.5MG;50MG	TABLET	ORAL	Rx	AB
25MG;100MG	TABLET	ORAL	Rx	AB

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

TEVA PHARMSANDA 07715720103 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
12.5MG;50MG	TABLET	ORAL	Rx	AB
12.5MG;100MG	TABLET	ORAL	Rx	AB
25MG;100MG	TABLET	ORAL	Rx	AB

Orange Book patent file

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

FDA approval span

Approval history

First approval

Apr 28, 1995

31 yr 8 mo ago

Most recent approval

May 27, 2026

2 mo ago

Approvals span 1995–2026 across 19 FDA applications.

Brand (NDA) 15%

Generic (ANDA) 1895%

Hydrochlorothiazide; losartan potassium — 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

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo