hydroxyzine pamoate

Product NDC
71335-3003
11-digit product format
713353003
Labeler code
71335
Product ID
71335-3003_8bce5771-3053-4dd0-94f4-fdfab8184f60
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydroxyzine pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA087479
Marketing category
ANDA
Marketing start
1981-12-14
Substance
HYDROXYZINE PAMOATE
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
M20215MUFRHYDROXYZINE PAMOATE10246-75-0HYDROXYZINE PAMOATE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-3003-17133530030130 CAPSULE in 1 BOTTLE (71335-3003-1) 30 capsule2025-11-04NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Hydroxyzine Pamoate Capsules, USPBryant Ranch Prepack2025-11-04HUMAN PRESCRIPTION DRUG LABEL100