Hydroxyzine Hydrochloride

Product NDC

0378-2588

11-digit product format

003782588

Labeler code

0378

Product ID

0378-2588_00b7c512-5d41-4218-870f-9838716c761e

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

hydroxyzine hydrochloride

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Mylan Pharmaceuticals Inc.

Application

ANDA091176

Marketing category

ANDA

Marketing start

2010-07-23

Marketing end

2019-09-30

Substance

HYDROXYZINE HYDROCHLORIDE

Active strength

50 mg/1

Pharmacologic classes

Antihistamine [EPC],Histamine Receptor Antagonists [MoA]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record