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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 076063

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NDA 076063 describes LISINOPRIL, which is a drug marketed by Accord Hlthcare, Ascent Pharms Inc, Aurobindo, Chartwell Rx, Corepharma, Heritage Pharma, Hikma Intl Pharms, Invagen Pharms, Lupin, Prinston Inc, Rising, Sciegen Pharms Inc, Strides Pharma, Sun Pharm Inds Ltd, Teva, Watson Labs, Wockhardt Bio Ag, Epic Pharma Llc, Pharmobedient, and Sandoz, and is included in thirty-two NDAs. It is available from thirty-seven suppliers. Additional details are available on the LISINOPRIL profile page.

The generic ingredient in LISINOPRIL is hydrochlorothiazide; lisinopril. There are thirty-two drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; lisinopril profile page.

Summary for 076063

Tradename:	LISINOPRIL
Applicant:	Hikma Intl Pharms
Ingredient:	lisinopril
Patents:	0

Medical Subject Heading (MeSH) Categories for 076063

Angiotensin-Converting Enzyme Inhibitors
Antihypertensive Agents
Cardiotonic Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	2.5MG
Approval Date:	Jul 1, 2002	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Jul 1, 2002	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Jul 1, 2002	TE:		RLD:	No

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