Hydroxyzine Pamoate

Product NDC
70934-444
11-digit product format
709340444
Labeler code
70934
Product ID
70934-444_a798f583-d691-728c-e053-2995a90af43a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA040156
Marketing category
ANDA
Marketing start
2019-09-19
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
70934-444-307093404443030 CAPSULE in 1 BOTTLE, PLASTIC (70934-444-30) 30 capsule2019-09-190000-00-00NoNoCurrent

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Hydroxyzine Pamoate Capsules, USP (25 mg and 50 mg) Rx onlyDenton Pharma, Inc. DBA Northwind Pharmaceuticals2020-06-08HUMAN PRESCRIPTION DRUG LABEL1