Hydroxyzine pamoate

Product NDC
50090-5934
11-digit product format
500905934
Labeler code
50090
Product ID
50090-5934_ac2efc14-7820-4146-8bdb-89491a569c4d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA086183
Marketing category
ANDA
Marketing start
1981-12-14
Marketing end
0000-00-00
Substance
HYDROXYZINE PAMOATE
Active strength
50 mg/1
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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
50090-5934-02024-01-30C16284748780-11030e365-5b8b-111a-e063-dadaa90a10e2Hydroxyzine Pamoate Capsules, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5934-0Hydroxyzine pamoate33 in 1 BOTTLECAPSULE331

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5934-0EA - Each50090-5934a0fd3b98-b570-4c34-9b5d-b3302ef3b9c312022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5934HYDROXYZINE PAMOATE CAPSULE [A-S MEDICATION SOLUTIONS]1Legacy NDC, 1 package rows20220331_737d39fd-4b11-4e8d-a546-ba9189fdbd9e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995278hydrOXYzine pamoate 50 MG Oral CapsulePSN737d39fd-4b11-4e8d-a546-ba9189fdbd9e1
995278hydroxyzine pamoate 50 MG Oral CapsuleSCD737d39fd-4b11-4e8d-a546-ba9189fdbd9e1
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSY737d39fd-4b11-4e8d-a546-ba9189fdbd9e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5934-05009059340033 CAPSULE in 1 BOTTLE (50090-5934-0) 33 capsule2022-03-070000-00-00NoNoCurrent