Hydroxyzine Pamoate

Product NDC
50090-4579
11-digit product format
500904579
Labeler code
50090
Product ID
50090-4579_c3c2c5f0-6ce2-4fb5-88a5-5505a53861d8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA040156
Marketing category
ANDA
Marketing start
1996-07-15
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4579-2Hydroxyzine Pamoate20 in 1 BOTTLECAPSULE2013
50090-4579-5Hydroxyzine Pamoate30 in 1 BOTTLECAPSULE3013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4579-2EA - Each50090-4579cd2fdcd7-5fb2-4016-a8a1-1780616d41a712023-12-05
50090-4579-5EA - Each50090-457967e11d10-aef5-4b56-9b6d-5811035a09b512023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4579HYDROXYZINE PAMOATE CAPSULE [A-S MEDICATION SOLUTIONS]13Current NDC, Legacy NDC, 2 package rows20231109_42186eab-89d1-4963-bfd8-087b3024af33.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN42186eab-89d1-4963-bfd8-087b3024af3313
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD42186eab-89d1-4963-bfd8-087b3024af3313

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4579-25009045790220 CAPSULE in 1 BOTTLE (50090-4579-2) 20 capsule2019-10-040000-00-00NoNoCurrent
50090-4579-55009045790530 CAPSULE in 1 BOTTLE (50090-4579-5) 30 capsule2019-10-040000-00-00NoNoCurrent