hydroxyzine pamoate

Product NDC
68071-2521
11-digit product format
680712521
Labeler code
68071
Product ID
68071-2521_ca8e95c7-b26b-a038-e053-2995a90a87a3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydroxyzine pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals,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
68071-2521-168071252101100 CAPSULE in 1 CONTAINER (68071-2521-1) 100 capsule2021-08-270000-00-00NoNoCurrent

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Rx onlyNuCare Pharmaceuticals,Inc.2023-07-14HUMAN PRESCRIPTION DRUG LABEL2