Hydroxyzine Hydrochloride

Product NDC
50090-7034
11-digit product format
500907034
Labeler code
50090
Product ID
50090-7034_8a418e3b-7933-4ce1-af23-34277e341353
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA040602
Marketing category
ANDA
Marketing start
2015-03-31
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
50090-7034-050090703400100 BLISTER PACK in 1 CARTON (50090-7034-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK100 blister pack2024-01-08NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Hydroxyzine Hydrochloride Tablets USP, Film-Coated Rx OnlyA-S Medication Solutions2024-03-11HUMAN PRESCRIPTION DRUG LABEL2