FDA Orange Book

Generic for Zestril

Zestril contains lisinopril. 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 Zestril is lisinopril. 11 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Zestril products in the Orange Book

Zestril products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
tablet, oral	10MG	Marketed (Rx)	AB	12	AB
tablet, oral	2.5MG	Marketed (Rx)	AB	12	AB
tablet, oral	20MG	Marketed (Rx)	AB	12	AB
tablet, oral	30MG	Marketed (Rx)	AB	12	AB
tablet, oral	40MG	Marketed (Rx)	AB	12	AB
tablet, oral	5MG	Marketed (Rx)	AB	12	AB

NDA 019777, held by TWI PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic lisinopril

Approved generic versions of Zestril
Company	ANDA	TE code	Approved	Strengths
ANNORA PHARMA PRIVATE LTD	075903	AB (A-rated, therapeutically equivalent)	July 1, 2002	10MG, 2.5MG, 20MG, 30MG, 40MG, 5MG
CHARTWELL RX SCIENCES LLC	075994	AB (A-rated, therapeutically equivalent)	July 1, 2002	10MG, 2.5MG, 20MG, 30MG, 40MG, 5MG
PRINSTON PHARMACEUTICAL INC	075743	AB (A-rated, therapeutically equivalent)	July 1, 2002	10MG, 2.5MG, 20MG, 30MG, 40MG, 5MG
PRINSTON PHARMACEUTICAL INC	076164	AB (A-rated, therapeutically equivalent)	July 1, 2002	10MG, 2.5MG, 20MG, 30MG, 40MG, 5MG
SUN PHARMACEUTICAL INDUSTRIES LTD	075944	AB (A-rated, therapeutically equivalent)	July 1, 2002	10MG, 2.5MG, 20MG, 30MG, 40MG, 5MG
WATSON LABORATORIES INC	076059	AB (A-rated, therapeutically equivalent)	July 1, 2002	10MG, 2.5MG, 20MG, 30MG, 40MG, 5MG
HERITAGE PHARMACEUTICALS INC DBA AVET PHARMACEUTICALS INC	076102	AB (A-rated, therapeutically equivalent)	September 30, 2002	10MG, 2.5MG, 20MG, 30MG, 40MG, 5MG
LUPIN LTD	077321	AB (A-rated, therapeutically equivalent)	September 9, 2005	10MG, 2.5MG, 20MG, 30MG, 40MG, 5MG
AUROBINDO PHARMA LTD	077622	AB (A-rated, therapeutically equivalent)	February 22, 2006	10MG, 2.5MG, 20MG, 30MG, 40MG, 5MG
WOCKHARDT BIO AG	078402	AB (A-rated, therapeutically equivalent)	April 19, 2007	10MG, 2.5MG, 20MG, 30MG, 40MG, 5MG
INVAGEN PHARMACEUTICALS INC	203508	AB (A-rated, therapeutically equivalent)	October 29, 2013	10MG, 2.5MG, 20MG, 30MG, 40MG, 5MG
SCIEGEN PHARMACEUTICALS INC	212041	AB (A-rated, therapeutically equivalent)	September 15, 2020	10MG, 2.5MG, 5MG
SCIEGEN PHARMACEUTICALS INC	208920	AB (A-rated, therapeutically equivalent)	March 4, 2021	20MG, 30MG, 40MG

Zestril NDC codes

Questions

Is there a generic for Zestril?

Yes. The generic name for Zestril is lisinopril. 11 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 Zestril?

The active ingredient in Zestril is lisinopril, 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.