FDA.reportPublic FDA data

hydroxyzine pamoate

Product NDC
50090-4385
11-digit product format
500904385
Labeler code
50090
Product ID
50090-4385_ee21822e-a146-4f65-beaf-d10c79474f44
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
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4385-22023-02-17C16284748780-1f386c649-d630-0266-e053-dadaa90a7c1aRx only
50090-4385-52023-02-17C16284748780-1f386c649-d630-0266-e053-dadaa90a7c1aRx only
50090-4385-22023-01-30C16284748780-1f386c649-d630-0266-e053-dadaa90a7c1aRx only
50090-4385-52023-01-30C16284748780-1f386c649-d630-0266-e053-dadaa90a7c1aRx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4385-0hydroxyzine pamoate50 in 1 BOTTLECAPSULE508
50090-4385-2hydroxyzine pamoate20 in 1 BOTTLECAPSULE208
50090-4385-5hydroxyzine pamoate30 in 1 BOTTLECAPSULE308

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4385-2EA - Each50090-438559f235b9-6099-45eb-b02e-653a8aa4df7112023-03-13
50090-4385-5EA - Each50090-438555db6b61-29db-4e40-a709-4368956ae3e512023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4385HYDROXYZINE PAMOATE CAPSULE [A-S MEDICATION SOLUTIONS]8Current NDC, Legacy NDC, 3 package rows20241010_a31271f0-ac60-4fda-b1f5-ddf7241c8a0e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995253hydrOXYzine pamoate 25 MG Oral CapsulePSNa31271f0-ac60-4fda-b1f5-ddf7241c8a0e8
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDa31271f0-ac60-4fda-b1f5-ddf7241c8a0e8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4385-05009043850050 CAPSULE in 1 BOTTLE (50090-4385-0) 50 capsule2019-06-25NoNoCurrent
50090-4385-25009043850220 CAPSULE in 1 BOTTLE (50090-4385-2) 20 capsule2019-06-250000-00-00NoNoCurrent
50090-4385-55009043850530 CAPSULE in 1 BOTTLE (50090-4385-5) 30 capsule2019-06-250000-00-00NoNoCurrent