FDA.reportPublic FDA data

hydroxyzine pamoate

Product NDC
50090-7540
11-digit product format
500907540
Labeler code
50090
Product ID
50090-7540_160e3ade-965e-4ea3-b6ec-a3554bba3507
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydroxyzine pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA201507
Marketing category
ANDA
Marketing start
2013-06-03
Substance
HYDROXYZINE PAMOATE
Active strength
50 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 PAMOATE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiM20215MUFR
Rxcui995278

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
50090-7540-0hydroxyzine pamoate12 in 1 BOTTLECAPSULE1210
50090-7540-1hydroxyzine pamoate20 in 1 BOTTLECAPSULE2010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7540-0EA - Each50090-75406fd4d5b0-0226-44fe-ada5-81fb22290f7212025-05-14
50090-7540-1EA - Each50090-7540d632cdca-853e-4ff5-983a-c6cc2478e42e12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7540HYDROXYZINE PAMOATE CAPSULE [A-S MEDICATION SOLUTIONS]10Current NDC, 2 package rows20250429_74bf62c3-b444-46dc-aab6-af74b101a68a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995278hydrOXYzine pamoate 50 MG Oral CapsulePSN74bf62c3-b444-46dc-aab6-af74b101a68a10
995278hydroxyzine pamoate 50 MG Oral CapsuleSCD74bf62c3-b444-46dc-aab6-af74b101a68a10
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSY74bf62c3-b444-46dc-aab6-af74b101a68a10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7540-05009075400012 CAPSULE in 1 BOTTLE (50090-7540-0) 12 capsule2025-04-23NoNoCurrent
50090-7540-15009075400120 CAPSULE in 1 BOTTLE (50090-7540-1) 20 capsule2025-04-23NoNoCurrent