Hydroxyzine Hydrochloride

Product NDC

63187-539

11-digit product format

631870539

Labeler code

63187

Product ID

63187-539_174c8714-3637-45c1-a1bc-5b5b4bc78fcb

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Hydroxyzine Hydrochloride

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Proficient Rx LP

Application

ANDA040804

Marketing category

ANDA

Marketing start

2008-06-30

Marketing end

0000-00-00

Substance

HYDROXYZINE HYDROCHLORIDE

Active strength

50 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