Hydroxyzine Hydrochloride

Product NDC

51079-816

11-digit product format

510790816

Labeler code

51079

Product ID

51079-816_7c5f5818-0a0f-556a-e053-2991aa0a69cc

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

hydroxyzine hydrochloride

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Mylan Institutional Inc.

Application

ANDA091176

Marketing category

ANDA

Marketing start

2010-08-13

Marketing end

2019-07-31

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