Hydroxyzine Hydrochloride

Product NDC
50090-6655
11-digit product format
500906655
Labeler code
50090
Product ID
50090-6655_55f40911-dfa2-4c85-8faa-a0d9ec530be1
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
50090-6655-05009066550020 TABLET, FILM COATED in 1 BOTTLE (50090-6655-0) 2023-08-30NoNoHistorical
50090-6655-15009066550130 TABLET, FILM COATED in 1 BOTTLE (50090-6655-1) 2023-08-30NoNoHistorical
50090-6655-45009066550460 TABLET, FILM COATED in 1 BOTTLE (50090-6655-4) 2023-08-30NoNoHistorical
50090-6655-65009066550615 TABLET, FILM COATED in 1 BOTTLE (50090-6655-6) 2023-08-30NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Hydroxyzine Hydrochloride Tablets USP, Film-Coated Rx OnlyA-S Medication Solutions2023-09-07HUMAN PRESCRIPTION DRUG LABEL2