Hydroxyzine Hydrochloride

Product NDC
71335-2776
11-digit product format
713352776
Labeler code
71335
Product ID
71335-2776_d7019ffc-0367-4a98-bbe2-ecd6efca509c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA087871
Marketing category
ANDA
Marketing start
2021-10-07
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
71335-2776-17133527760130 TABLET, FILM COATED in 1 BOTTLE (71335-2776-1) 2025-10-13NoNoHistorical
71335-2776-27133527760260 TABLET, FILM COATED in 1 BOTTLE (71335-2776-2) 2025-10-13NoNoHistorical
71335-2776-37133527760320 TABLET, FILM COATED in 1 BOTTLE (71335-2776-3) 2025-10-13NoNoHistorical
71335-2776-471335277604100 TABLET, FILM COATED in 1 BOTTLE (71335-2776-4) 2025-10-13NoNoHistorical
71335-2776-57133527760515 TABLET, FILM COATED in 1 BOTTLE (71335-2776-5) 2025-10-13NoNoHistorical
71335-2776-67133527760690 TABLET, FILM COATED in 1 BOTTLE (71335-2776-6) 2025-10-13NoNoHistorical
71335-2776-77133527760719 TABLET, FILM COATED in 1 BOTTLE (71335-2776-7) 2025-10-13NoNoHistorical
71335-2776-87133527760810 TABLET, FILM COATED in 1 BOTTLE (71335-2776-8) 2025-10-13NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Hydroxyzine Hydrochloride Tablets, USP Rx onlyBryant Ranch Prepack2025-10-13HUMAN PRESCRIPTION DRUG LABEL1