Last Updated: September 24, 2026

Details for New Drug Application (NDA): 086242

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NDA 086242 describes HYDRALAZINE HYDROCHLORIDE, which is a drug marketed by Abraxis Pharm, Am Regent, Baxter Hlthcare Corp, Eugia Pharma, Fresenius Kabi Usa, Hikma, Kindos, Navinta Llc, Pharmobedient, Rising, Smith And Nephew, Solopak, Teva Parenteral, Actavis Elizabeth, Actavis Grp Ptc, Alkem Labs Ltd, Ascot, Cadila Pharms Ltd, Chartwell Rx, Glenmark Pharms Ltd, Halsey, Heritage, Heritage Pharms Inc, Hetero Labs Ltd Iii, Impax Labs, Invagen Pharms, Ivax Sub Teva Pharms, Macleods Pharms, Mutual Pharm, Pliva, Purepac Pharm, Quantum Pharmics, Sciegen Pharms, Strides Pharma, Strides Pharma Intl, Superpharm, Tp Anda Holdings, Upsher Smith Labs, Usl Pharma, Vangard, Vitarine, Watson Labs, West Ward, Solvay, Ivax Pharms, and Mylan, and is included in ninety-seven NDAs. It is available from forty-three suppliers. Additional details are available on the HYDRALAZINE HYDROCHLORIDE profile page.

The generic ingredient in HYDRALAZINE HYDROCHLORIDE is hydralazine hydrochloride; hydrochlorothiazide; reserpine. There are three drug master file entries for this compound. Additional details are available on the hydralazine hydrochloride; hydrochlorothiazide; reserpine profile page.

Summary for 086242

Tradename:	HYDRALAZINE HYDROCHLORIDE
Applicant:	Heritage
Ingredient:	hydralazine hydrochloride
Patents:	0

Pharmacology for NDA: 086242

Physiological Effect	Arteriolar Vasodilation

Medical Subject Heading (MeSH) Categories for 086242

Antihypertensive Agents
Vasodilator Agents

Suppliers and Packaging for NDA: 086242

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
HYDRALAZINE HYDROCHLORIDE	hydralazine hydrochloride	TABLET;ORAL	086242	ANDA	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-003	23155-003-01	100 TABLET, FILM COATED in 1 BOTTLE (23155-003-01)
HYDRALAZINE HYDROCHLORIDE	hydralazine hydrochloride	TABLET;ORAL	086242	ANDA	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-003	23155-003-10	1000 TABLET, FILM COATED in 1 BOTTLE (23155-003-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Feb 4, 2010	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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