FDA.reportPublic FDA data

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

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
71610-773-30hydroxyzine pamoate30 in 1 CONTAINERCAPSULE302
71610-773-53hydroxyzine pamoate60 in 1 CONTAINERCAPSULE602
71610-773-60hydroxyzine pamoate90 in 1 CONTAINERCAPSULE902
71610-773-70hydroxyzine pamoate120 in 1 CONTAINERCAPSULE1202
71610-773-80hydroxyzine pamoate180 in 1 CONTAINERCAPSULE1802

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-773-30EA - Each71610-7736e97e2bf-db23-4627-a6e0-4428a82a96ef12024-03-12
71610-773-53EA - Each71610-7733b3f8a36-7202-4219-b3e6-937a93fbf56912024-03-12
71610-773-60EA - Each71610-7738d1bf688-364c-4b89-a69d-09f69ced0bf512024-03-12
71610-773-70EA - Each71610-773e0dcaebc-4bed-4978-9feb-fb5fe0fb6a9a12024-03-12
71610-773-80EA - Each71610-77341c5a9d7-99c7-47a0-b1a3-bbf56ee3df3512024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-773HYDROXYZINE PAMOATE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, 5 package rows20240209_78005ad7-290c-4716-937f-f0ec82f4e607.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN78005ad7-290c-4716-937f-f0ec82f4e6072
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD78005ad7-290c-4716-937f-f0ec82f4e6072

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-773-307161007733030 CAPSULE in 1 CONTAINER (71610-773-30) 30 capsule2024-01-25NoNoCurrent
71610-773-537161007735360 CAPSULE in 1 CONTAINER (71610-773-53) 60 capsule2024-01-22NoNoCurrent
71610-773-607161007736090 CAPSULE in 1 CONTAINER (71610-773-60) 90 capsule2024-01-25NoNoCurrent
71610-773-7071610077370120 CAPSULE in 1 CONTAINER (71610-773-70) 120 capsule2024-01-25NoNoCurrent
71610-773-8071610077380180 CAPSULE in 1 CONTAINER (71610-773-80) 180 capsule2024-01-22NoNoCurrent