hydroxyzine pamoate

Product NDC
53002-6212
11-digit product format
530026212
Labeler code
53002
Product ID
53002-6212_8ed44aee-e8f7-4c9e-b30a-2d615304832c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydroxyzine pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA087479
Marketing category
ANDA
Marketing start
1981-12-14
Marketing end
0000-00-00
Substance
HYDROXYZINE PAMOATE
Active strength
25 mg/1
Pharmacologic classes
Antihistamine [EPC],Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
M20215MUFRHYDROXYZINE PAMOATE10246-75-0HYDROXYZINE PAMOATE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-6212-15300262120110 CAPSULE in 1 BOTTLE (53002-6212-1) 10 capsule2019-01-010000-00-00NoNoCurrent
53002-6212-25300262120220 CAPSULE in 1 BOTTLE (53002-6212-2) 20 capsule2019-01-010000-00-00NoNoCurrent
53002-6212-35300262120330 CAPSULE in 1 BOTTLE (53002-6212-3) 30 capsule2019-01-010000-00-00NoNoCurrent
53002-6212-55300262120515 CAPSULE in 1 BOTTLE (53002-6212-5) 15 capsule2019-01-010000-00-00NoNoCurrent

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
HydrOXYzine Pamoate Capsules, USPRPK Pharmaceuticals, Inc.2020-12-23HUMAN PRESCRIPTION DRUG LABEL1