FDA.reportPublic FDA data

hydroxyzine pamoate

Product NDC
51407-001
11-digit product format
514070001
Labeler code
51407
Product ID
51407-001_3bb4ba66-6b1b-ed24-e063-6394a90a37df
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydroxyzine pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
Golden State Medical Supply, 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
51407-001-01hydroxyzine pamoate100 in 1 CONTAINERCAPSULE1002
51407-001-05hydroxyzine pamoate500 in 1 CONTAINERCAPSULE5002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-001HYDROXYZINE PAMOATE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]1Current NDC, 2 package rows20241013_240fd428-15af-e7d0-e063-6394a90acbc5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN240fd428-15af-e7d0-e063-6394a90acbc52
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN308cd178-a9d2-3132-e063-6394a90a73572
995278hydrOXYzine pamoate 50 MG Oral CapsulePSN240fd428-15af-e7d0-e063-6394a90acbc52
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD240fd428-15af-e7d0-e063-6394a90acbc52
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD308cd178-a9d2-3132-e063-6394a90a73572
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51407-001-0151407000101100 CAPSULE in 1 CONTAINER (51407-001-01) 100 capsule2024-08-29NoNoCurrent
51407-001-0551407000105500 CAPSULE in 1 CONTAINER (51407-001-05) 500 capsule2024-08-29NoNoCurrent