HYDROXYZINE HYDROCHLORIDE

Product NDC
50090-7332
11-digit product format
500907332
Labeler code
50090
Product ID
50090-7332_ce131f43-290a-4570-9fe3-280fc32f33d1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydroxyzine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA217652
Marketing category
ANDA
Marketing start
2023-08-22
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 formatDescriptionMarketing startSampleExclude flagStatus
50090-7332-05009073320030 TABLET, FILM COATED in 1 BOTTLE (50090-7332-0) 2024-10-15NoNoHistorical
50090-7332-15009073320128 TABLET, FILM COATED in 1 BOTTLE (50090-7332-1) 2024-10-19NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Hydroxyzine Hydrochloride Tablets, USP Rx onlyA-S Medication Solutions2025-12-02HUMAN PRESCRIPTION DRUG LABEL3