Hydroxyzine Pamoate

Product NDC
67296-1660
11-digit product format
672961660
Labeler code
67296
Product ID
67296-1660_b8df9cca-bae3-58f5-e053-2a95a90af5e4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA040156
Marketing category
ANDA
Marketing start
2019-01-01
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
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
67296-1660-36729616600330 CAPSULE in 1 BOTTLE (67296-1660-3) 30 capsule2019-01-010000-00-00NoNoCurrent
67296-1660-76729616600715 CAPSULE in 1 BOTTLE (67296-1660-7) 15 capsule2019-10-310000-00-00NoNoCurrent

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Hydroxyzine Pamoate 25mgRedPharm Drug, Inc.2021-01-14HUMAN PRESCRIPTION DRUG LABEL4