hydroxyzine pamoate

Product NDC
67296-1719
11-digit product format
672961719
Labeler code
67296
Product ID
67296-1719_b8dfb538-7989-5311-e053-2995a90a07bd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydroxyzine pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA201507
Marketing category
ANDA
Marketing start
2013-06-03
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
2022-12-31
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
67296-1719-36729617190330 CAPSULE in 1 BOTTLE (67296-1719-3) 30 capsule2019-11-010000-00-00NoNoCurrent
67296-1719-76729617190715 CAPSULE in 1 BOTTLE (67296-1719-7) 15 capsule2019-11-010000-00-00NoNoCurrent

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Hydroxyzine Pamoate 25mgRedPharm Drug, Inc.2021-01-14HUMAN PRESCRIPTION DRUG LABEL3