Last Updated: June 25, 2026

Details for New Drug Application (NDA): 204279

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NDA 204279 describes HYDROXYZINE HYDROCHLORIDE, which is a drug marketed by Altana, Am Regent, Baxter Hlthcare, Dr Reddys, Fresenius Kabi Usa, Hospira, Pharmafair, Smith And Nephew, Solopak, Watson Labs, Wyeth Ayerst, Alpharma Us Pharms, Apozeal Pharms, Bionpharma, Chartwell Rx, Hikma, Kv Pharm, Lannett Co Inc, Novitium Pharma, Pai Holdings Pharm, Rising, Able, Actavis Elizabeth, Amneal Pharm, Aurobindo Pharma Ltd, Epic Pharma Llc, Graviti Pharms, Halsey, Heritage, Hetero Labs Ltd Iii, Ivax Pharms, Kvk Tech, Mutual Pharm, Northstar Hlthcare, Nuvo Pharms Inc, Pliva, Prinston Inc, Purepac Pharm, Quantum Pharmics, Sandoz, Somerset Theraps Llc, Strides Pharma Intl, Sun Pharm Inds Inc, Sun Pharm Industries, Superpharm, and Usl Pharma, and is included in one hundred and two NDAs. It is available from fifty-one suppliers. Additional details are available on the HYDROXYZINE HYDROCHLORIDE profile page.

The generic ingredient in HYDROXYZINE HYDROCHLORIDE is hydroxyzine hydrochloride. There are nineteen drug master file entries for this compound. Fifty-one suppliers are listed for this compound. Additional details are available on the hydroxyzine hydrochloride profile page.

Summary for 204279

Tradename:	HYDROXYZINE HYDROCHLORIDE
Applicant:	Heritage
Ingredient:	hydroxyzine hydrochloride
Patents:	0

Pharmacology for NDA: 204279

Mechanism of Action	Histamine Receptor Antagonists

Suppliers and Packaging for NDA: 204279

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
HYDROXYZINE HYDROCHLORIDE	hydroxyzine hydrochloride	TABLET;ORAL	204279	ANDA	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8082	0615-8082-05	15 TABLET in 1 BLISTER PACK (0615-8082-05)
HYDROXYZINE HYDROCHLORIDE	hydroxyzine hydrochloride	TABLET;ORAL	204279	ANDA	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8082	0615-8082-28	28 TABLET in 1 BLISTER PACK (0615-8082-28)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Aug 20, 2014	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Aug 20, 2014	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Aug 20, 2014	TE:	AB	RLD:	No

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