Hydroxyzine Hydrochloride

Product NDC

67405-575

11-digit product format

674050575

Labeler code

67405

Product ID

67405-575_5aea21fd-0695-44ba-bceb-72ad5b23496f

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Hydroxyzine

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

HARRIS Pharmaceutical, Inc.

Application

ANDA040808

Marketing category

ANDA

Marketing start

2007-06-29

Marketing end

0000-00-00

Substance

HYDROXYZINE HYDROCHLORIDE

Active strength

10 mg/1

Pharmacologic classes

Antihistamine [EPC],Histamine Receptor Antagonists [MoA]

NDC exclude flag

No

Listing certified through

2020-12-31

Current FDA listing

Historical FDA.report record