FDA.reportPublic FDA data

hydroxyzine pamoate

Product NDC
14539-674
11-digit product format
145390674
Labeler code
14539
Product ID
14539-674_843627c2-146c-4715-b5b5-8c5c80a8f615
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydroxyzine pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
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, 995278

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
14539-674-01hydroxyzine pamoate100 in 1 CONTAINERCAPSULE1006
14539-674-05hydroxyzine pamoate500 in 1 CONTAINERCAPSULE5006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
14539-674-01EA - Each14539-67463098642-df46-4659-bd66-b833aeec532e12019-07-02
14539-674-05EA - Each14539-6741314d75c-980b-4904-8ad9-fd33a96ac99a12019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14539-674HYDROXYZINE PAMOATE CAPSULE [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 2 package rows20240203_734d32c8-38d3-430f-a2b3-539e03a3687a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN7996dfa3-7f34-4d20-acaa-7f6fc021fc80106
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD7996dfa3-7f34-4d20-acaa-7f6fc021fc80106
995253hydrOXYzine pamoate 25 MG Oral CapsulePSNa31271f0-ac60-4fda-b1f5-ddf7241c8a0e8
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDa31271f0-ac60-4fda-b1f5-ddf7241c8a0e8
995253hydrOXYzine pamoate 25 MG Oral CapsulePSNf28f2a1b-8d65-4646-bd99-6e77617f9e1f6
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN2a66117a-fcd4-4094-927c-3a7699ef96606
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN734d32c8-38d3-430f-a2b3-539e03a3687a6
995278hydrOXYzine pamoate 50 MG Oral CapsulePSN734d32c8-38d3-430f-a2b3-539e03a3687a6
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDf28f2a1b-8d65-4646-bd99-6e77617f9e1f6
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD734d32c8-38d3-430f-a2b3-539e03a3687a6
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD2a66117a-fcd4-4094-927c-3a7699ef96606
995278hydroxyzine pamoate 50 MG Oral CapsuleSCD734d32c8-38d3-430f-a2b3-539e03a3687a6
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSY734d32c8-38d3-430f-a2b3-539e03a3687a6
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN8cb94f1d-1e45-531a-e053-2a95a90a1ba05
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD8cb94f1d-1e45-531a-e053-2a95a90a1ba05
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN8c395a13-9da3-7b77-e053-2995a90a19164
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD8c395a13-9da3-7b77-e053-2995a90a19164
995253hydrOXYzine pamoate 25 MG Oral CapsulePSNdb8987d6-9814-50f6-e053-2a95a90a82a93
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN96dc0948-9f04-5b28-e053-2995a90a83453
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDdb8987d6-9814-50f6-e053-2a95a90a82a93
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD96dc0948-9f04-5b28-e053-2995a90a83453
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN78005ad7-290c-4716-937f-f0ec82f4e6072
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN240fd428-15af-e7d0-e063-6394a90acbc52
995253hydrOXYzine pamoate 25 MG Oral CapsulePSNd9026566-63d8-416f-9722-92b5bdb45ed32
995253hydrOXYzine pamoate 25 MG Oral CapsulePSNca8e86ea-b6b4-6a40-e053-2995a90adf112
995253hydrOXYzine pamoate 25 MG Oral CapsulePSNb7f806ed-da18-41f2-aa0b-bce2336f27562
995278hydrOXYzine pamoate 50 MG Oral CapsulePSN240fd428-15af-e7d0-e063-6394a90acbc52
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDb7f806ed-da18-41f2-aa0b-bce2336f27562
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDca8e86ea-b6b4-6a40-e053-2995a90adf112
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDd9026566-63d8-416f-9722-92b5bdb45ed32
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD240fd428-15af-e7d0-e063-6394a90acbc52
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD78005ad7-290c-4716-937f-f0ec82f4e6072
995278hydroxyzine pamoate 50 MG Oral CapsuleSCD240fd428-15af-e7d0-e063-6394a90acbc52
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSY240fd428-15af-e7d0-e063-6394a90acbc52
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN5020c699-6fc5-b166-e063-6294a90a58811
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN8c397c3f-d51b-c3ef-e053-2995a90a8eb51
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD5020c699-6fc5-b166-e063-6294a90a58811
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD8c397c3f-d51b-c3ef-e053-2995a90a8eb51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
14539-674-0114539067401100 CAPSULE in 1 CONTAINER (14539-674-01) 100 capsule2019-04-230000-00-00NoNoCurrent
14539-674-0514539067405500 CAPSULE in 1 CONTAINER (14539-674-05) 500 capsule2019-04-230000-00-00NoNoCurrent