hydroxyzine pamoate

Product NDC
71610-773
11-digit product format
716100773
Labeler code
71610
Product ID
71610-773_06a770d3-1061-4bea-91cb-9b047f31a907
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydroxyzine pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA201507
Marketing category
ANDA
Marketing start
2013-06-03
Substance
HYDROXYZINE PAMOATE
Active strength
25 mg/1
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
M20215MUFRHYDROXYZINE PAMOATE10246-75-0HYDROXYZINE PAMOATE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-773-307161007733030 CAPSULE in 1 CONTAINER (71610-773-30) 30 capsule2024-01-25NoNoHistorical
71610-773-537161007735360 CAPSULE in 1 CONTAINER (71610-773-53) 60 capsule2024-01-22NoNoHistorical
71610-773-607161007736090 CAPSULE in 1 CONTAINER (71610-773-60) 90 capsule2024-01-25NoNoHistorical
71610-773-7071610077370120 CAPSULE in 1 CONTAINER (71610-773-70) 120 capsule2024-01-25NoNoHistorical
71610-773-8071610077380180 CAPSULE in 1 CONTAINER (71610-773-80) 180 capsule2024-01-22NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Rx onlyAphena Pharma Solutions - Tennessee, LLC2024-02-06HUMAN PRESCRIPTION DRUG LABEL2