Hydroxyzine Pamoate

Product NDC
53002-6211
11-digit product format
530026211
Labeler code
53002
Product ID
53002-6211_0e79d89f-4422-4c5f-bfa1-fe83c9ac9855
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA088496
Marketing category
ANDA
Marketing start
1984-07-01
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
53002-6211-15300262110110 CAPSULE in 1 BOTTLE (53002-6211-1) 10 capsule2018-10-010000-00-00NoNoCurrent
53002-6211-25300262110220 CAPSULE in 1 BOTTLE (53002-6211-2) 20 capsule2018-10-010000-00-00NoNoCurrent
53002-6211-35300262110330 CAPSULE in 1 BOTTLE (53002-6211-3) 30 capsule2018-10-010000-00-00NoNoCurrent

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
HydrOXYzine Pamoate Capsules USPRPK Pharmaceuticals, Inc.2020-12-16HUMAN PRESCRIPTION DRUG LABEL3