Hydroxyzine Pamoate

Product NDC
68071-2573
11-digit product format
680712573
Labeler code
68071
Product ID
68071-2573_d0d91cc2-ef07-d019-e053-2a95a90aa365
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA040156
Marketing category
ANDA
Marketing start
1996-07-15
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
68071-2573-168071257301100 CAPSULE in 1 BOTTLE, PLASTIC (68071-2573-1) 100 capsule2021-11-150000-00-00NoNoCurrent

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Hydroxyzine Pamoate Capsules, USP (25 mg and 50 mg) Rx onlyNuCare Pharmaceuticals,Inc.2023-07-17HUMAN PRESCRIPTION DRUG LABEL3