Hydroxyzine Hydrochloride

Product NDC
60687-875
11-digit product format
606870875
Labeler code
60687
Product ID
60687-875_3ed83eb8-0be6-13bd-e063-6394a90a831d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
American Health Packaging
Application
ANDA087871
Marketing category
ANDA
Marketing start
2025-09-11
Substance
HYDROXYZINE DIHYDROCHLORIDE
Active strength
50 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
60687-875-0160687087501100 BLISTER PACK in 1 CARTON (60687-875-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-875-11) 100 blister pack2025-09-11NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Hydroxyzine Hydrochloride Tablets, USP 8487501/1124 Rx onlyAmerican Health Packaging2025-09-15HUMAN PRESCRIPTION DRUG LABEL2