HYDROXYZINE HYDROCHLORIDE

Product NDC
60760-990
11-digit product format
607600990
Labeler code
60760
Product ID
60760-990_30b6f6a5-9c36-af93-e063-6294a90a0228
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydroxyzine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
ST. MARY'S MEDICAL PARK PHARMACY
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
60760-990-306076009903030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-990-30) 2025-03-19NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Hydroxyzine Hydrochloride Tablets, USP Rx onlyST. MARY'S MEDICAL PARK PHARMACY2025-03-19HUMAN PRESCRIPTION DRUG LABEL1