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Last Updated: March 18, 2026

Details for New Drug Application (NDA): 040604

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NDA 040604 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 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 suppliers are listed for this compound. Additional details are available on the hydroxyzine hydrochloride profile page.

Summary for 040604

Tradename:	HYDROXYZINE HYDROCHLORIDE
Applicant:	Epic Pharma Llc
Ingredient:	hydroxyzine hydrochloride
Patents:	0

Pharmacology for NDA: 040604

Mechanism of Action	Histamine Receptor Antagonists

Suppliers and Packaging for NDA: 040604

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
HYDROXYZINE HYDROCHLORIDE	hydroxyzine hydrochloride	TABLET;ORAL	040604	ANDA	Major Pharmaceuticals	0904-6617	0904-6617-61	100 BLISTER PACK in 1 CARTON (0904-6617-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK
HYDROXYZINE HYDROCHLORIDE	hydroxyzine hydrochloride	TABLET;ORAL	040604	ANDA	Major Pharmaceuticals	0904-6618	0904-6618-61	100 BLISTER PACK in 1 CARTON (0904-6618-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Dec 28, 2004	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Dec 28, 2004	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Dec 28, 2004	TE:	AB	RLD:	No

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