FDA Orange Book

Generic for Zestoretic

Zestoretic contains lisinopril and hydrochlorothiazide. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.

Source: FDA Orange Book data file dated 2026-10-09. Publisher page

Yes. The generic name for Zestoretic is lisinopril and hydrochlorothiazide. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Zestoretic products in the Orange Book

Zestoretic products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
tablet, oral	12.5MG;10MG	Marketed (Rx)	AB	8	AB
tablet, oral	12.5MG;20MG	Marketed (Rx)	AB	8	AB
tablet, oral	25MG;20MG	Marketed (Rx)	AB	8	AB

NDA 019888, held by ALMATICA PHARMA LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic lisinopril and hydrochlorothiazide

Approved generic versions of Zestoretic
Company	ANDA	TE code	Approved	Strengths
AIPING PHARMACEUTICAL INC	076262	AB (A-rated, therapeutically equivalent)	July 1, 2002	12.5MG;10MG, 12.5MG;20MG, 25MG;20MG
PRINSTON PHARMACEUTICAL INC	076230	AB (A-rated, therapeutically equivalent)	July 1, 2002	12.5MG;10MG, 12.5MG;20MG, 25MG;20MG
SUN PHARMACEUTICAL INDUSTRIES LTD	076007	AB (A-rated, therapeutically equivalent)	July 1, 2002	12.5MG;10MG, 12.5MG;20MG, 25MG;20MG
WATSON LABS INC	076194	AB (A-rated, therapeutically equivalent)	July 1, 2002	12.5MG;10MG, 12.5MG;20MG, 25MG;20MG
MACLEODS PHARMACEUTICALS LTD	076674	AB (A-rated, therapeutically equivalent)	October 5, 2004	12.5MG;10MG, 12.5MG;20MG, 25MG;20MG
AUROBINDO PHARMA LTD	077606	AB (A-rated, therapeutically equivalent)	March 14, 2006	12.5MG;10MG, 12.5MG;20MG, 25MG;20MG
LUPIN LTD	077912	AB (A-rated, therapeutically equivalent)	September 27, 2006	12.5MG;10MG, 12.5MG;20MG, 25MG;20MG
INVAGEN PHARMACEUTICALS INC	204058	AB (A-rated, therapeutically equivalent)	May 23, 2017	12.5MG;10MG, 12.5MG;20MG, 25MG;20MG

Zestoretic NDC codes

Questions

Is there a generic for Zestoretic?

Yes. The generic name for Zestoretic is lisinopril and hydrochlorothiazide. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

What is the generic name for Zestoretic?

The active ingredient in Zestoretic is lisinopril and hydrochlorothiazide, per the FDA Orange Book.

What does a therapeutic equivalence code mean?

In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.