hydroxyzine pamoate

Product NDC
71610-747
11-digit product format
716100747
Labeler code
71610
Product ID
71610-747_04ca77ea-a8b9-43aa-a4d4-89dbd1bdc0c2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydroxyzine pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA087479
Marketing category
ANDA
Marketing start
1981-12-14
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
71610-747-307161007473030 CAPSULE in 1 BOTTLE (71610-747-30) 30 capsule2023-11-02NoNoHistorical
71610-747-537161007475360 CAPSULE in 1 BOTTLE (71610-747-53) 60 capsule2023-11-02NoNoHistorical
71610-747-607161007476090 CAPSULE in 1 BOTTLE (71610-747-60) 90 capsule2023-11-15NoNoHistorical
71610-747-7071610074770120 CAPSULE in 1 BOTTLE (71610-747-70) 120 capsule2023-11-02NoNoHistorical
71610-747-8071610074780180 CAPSULE in 1 BOTTLE (71610-747-80) 180 capsule2023-11-02NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Hydroxyzine Pamoate Capsules, USPAphena Pharma Solutions - Tennessee, LLC2023-11-15HUMAN PRESCRIPTION DRUG LABEL2