Hydroxyzine Hydrochloride

Product NDC
55154-2148
11-digit product format
551542148
Labeler code
55154
Product ID
55154-2148_b4d274ce-d616-4835-80ce-76270524ed36
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA088618
Marketing category
ANDA
Marketing start
2025-10-22
Substance
HYDROXYZINE DIHYDROCHLORIDE
Active strength
25 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 formatDescriptionUnitsMarketing startSampleExclude flagStatus
55154-2148-05515421480010 BLISTER PACK in 1 BAG (55154-2148-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2025-10-22NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
HydrOXYzine Hydrochloride Tablets USP 8466401/0222 Rx onlyCardinal Health 107, LLC2025-10-22HUMAN PRESCRIPTION DRUG LABEL1