HYDROXYZINE HYDROCHLORIDE

Product NDC
68788-8872
11-digit product format
687888872
Labeler code
68788
Product ID
68788-8872_a35d1fe2-328d-42ff-ba1f-18a7f2f03c88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydroxyzine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA217652
Marketing category
ANDA
Marketing start
2025-05-01
Substance
HYDROXYZINE DIHYDROCHLORIDE
Active strength
10 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
68788-8872-36878888720330 TABLET, FILM COATED in 1 BOTTLE (68788-8872-3) 2025-05-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Hydroxyzine Hydrochloride Tablets, USP Rx onlyPreferred Pharmaceuticals Inc.2025-05-01HUMAN PRESCRIPTION DRUG LABEL1