Hydroxyzine Hydrochloride

Product NDC
50090-6657
11-digit product format
500906657
Labeler code
50090
Product ID
50090-6657_f8934174-e679-418a-a77c-9d3c57f15ce4
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 formatDescriptionMarketing startSampleExclude flagStatus
50090-6657-05009066570090 TABLET, FILM COATED in 1 BOTTLE (50090-6657-0) 2023-08-30NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Hydroxyzine Hydrochloride Tablets USP, Film-Coated Rx OnlyA-S Medication Solutions2024-01-04HUMAN PRESCRIPTION DRUG LABEL1