FDA.reportPublic FDA data

hydroxyzine pamoate

Product NDC
71610-883
11-digit product format
716100883
Labeler code
71610
Product ID
71610-883_33d81d2f-6f2c-d96e-e063-6394a90a4106
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

Additional Listing Data#

Finished product
Yes
Brand name base
hydroxyzine pamoate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROXYZINE PAMOATE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiM20215MUFR
Rxcui995253

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
57311cfb-679a-da1a-b70c-8757f7fc431aProduct name420250516
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
aa1826f4-97c1-4705-bdf0-3bc7d234e618Product name220190618
75cb12ee-8eb2-4f1a-a332-5743a5d0da41Product name120151110
3ca5f78b-43dc-30fe-8014-55b922af52b3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-883-30hydroxyzine pamoate30 in 1 BOTTLECAPSULE302
71610-883-53hydroxyzine pamoate60 in 1 BOTTLECAPSULE602
71610-883-60hydroxyzine pamoate90 in 1 BOTTLECAPSULE902
71610-883-70hydroxyzine pamoate120 in 1 BOTTLECAPSULE1202
71610-883-80hydroxyzine pamoate180 in 1 BOTTLECAPSULE1802

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-883-30EA - Each71610-883b74b7b49-1d5d-4fd1-ba1e-98086ba0169e12025-06-13
71610-883-53EA - Each71610-8838b35ad25-695a-4764-a094-bf60b760403a12025-06-13
71610-883-60EA - Each71610-883942989d5-2fed-4eac-b284-a57b9392efb112025-06-13
71610-883-70EA - Each71610-883c7fb36f6-b99c-479a-8636-983f8b76557612025-06-13
71610-883-80EA - Each71610-883438d6ff0-7d9c-4418-a6ca-36e08d996ece12025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-883HYDROXYZINE PAMOATE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ]2Current NDC, 5 package rows20250429_308cd178-a9d2-3132-e063-6394a90a7357.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN308cd178-a9d2-3132-e063-6394a90a73572
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD308cd178-a9d2-3132-e063-6394a90a73572

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-883-307161008833030 CAPSULE in 1 BOTTLE (71610-883-30) 30 capsule2025-04-25NoNoHistorical
71610-883-537161008835360 CAPSULE in 1 BOTTLE (71610-883-53) 60 capsule2025-04-25NoNoHistorical
71610-883-607161008836090 CAPSULE in 1 BOTTLE (71610-883-60) 90 capsule2025-03-13NoNoHistorical
71610-883-7071610088370120 CAPSULE in 1 BOTTLE (71610-883-70) 120 capsule2025-04-25NoNoHistorical
71610-883-8071610088380180 CAPSULE in 1 BOTTLE (71610-883-80) 180 capsule2025-03-13NoNoHistorical