Hydroxyzine Hydrochloride

Product NDC
43063-943
11-digit product format
430630943
Labeler code
43063
Product ID
43063-943_415eeebb-cc6b-0538-e063-6394a90a1ac9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydroxyzine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA040786
Marketing category
ANDA
Marketing start
2012-07-24
Substance
HYDROXYZINE DIHYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
76755771U3HYDROXYZINE HYDROCHLORIDE2192-20-3hydroxyzine hydrochloride

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
43063-943-304306309433030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-943-30) 2018-01-31NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
HYDROXYZINE HYDROCHLORIDE TABLETS, USPPD-Rx Pharmaceuticals, Inc.2025-10-17HUMAN PRESCRIPTION DRUG LABEL18
HYDROXYZINE HYDROCHLORIDE TABLETS, USPPD-Rx Pharmaceuticals, Inc.2024-10-16HUMAN PRESCRIPTION DRUG LABEL17