FDA.reportPublic FDA data

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

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
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
71610-747-30hydroxyzine pamoate30 in 1 BOTTLECAPSULE302
71610-747-53hydroxyzine pamoate60 in 1 BOTTLECAPSULE602
71610-747-60hydroxyzine pamoate90 in 1 BOTTLECAPSULE902
71610-747-70hydroxyzine pamoate120 in 1 BOTTLECAPSULE1202
71610-747-80hydroxyzine pamoate180 in 1 BOTTLECAPSULE1802

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-747-30EA - Each71610-74789c8c043-039a-4e02-be1e-11d00c96810112024-01-04
71610-747-53EA - Each71610-747c37e9672-ba18-4c7f-b6c7-6d50ff07bb8412024-01-04
71610-747-60EA - Each71610-74708317b89-add3-4a4b-9b7e-1fc324e4cb1712024-01-04
71610-747-70EA - Each71610-747dbe2c588-e335-441a-b014-e28ddef2a5bf12024-01-04
71610-747-80EA - Each71610-74759bdf8f7-c48c-40ca-9dc9-1baaa7f6307112024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-747HYDROXYZINE PAMOATE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, 5 package rows20231116_c29f005e-ae75-415d-9fd6-591f074dcda5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995253hydrOXYzine pamoate 25 MG Oral CapsulePSNc29f005e-ae75-415d-9fd6-591f074dcda52
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDc29f005e-ae75-415d-9fd6-591f074dcda52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-747-307161007473030 CAPSULE in 1 BOTTLE (71610-747-30) 30 capsule2023-11-02NoNoCurrent
71610-747-537161007475360 CAPSULE in 1 BOTTLE (71610-747-53) 60 capsule2023-11-02NoNoCurrent
71610-747-607161007476090 CAPSULE in 1 BOTTLE (71610-747-60) 90 capsule2023-11-15NoNoCurrent
71610-747-7071610074770120 CAPSULE in 1 BOTTLE (71610-747-70) 120 capsule2023-11-02NoNoCurrent
71610-747-8071610074780180 CAPSULE in 1 BOTTLE (71610-747-80) 180 capsule2023-11-02NoNoCurrent