Hydroxyzine Pamoate

Product NDC
50090-3909
11-digit product format
500903909
Labeler code
50090
Product ID
50090-3909_5f9edb2f-93f2-42e6-a918-2429002112d3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA088487
Marketing category
ANDA
Marketing start
1984-07-01
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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
57311cfb-679a-da1a-b70c-8757f7fc431aProduct name420250516
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316
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
50090-3909-02023-01-30C16284748780-1f386c64a-205d-0266-e053-dadaa90a7c1aHydrOXYzine Pamoate Capsules USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3909-0Hydroxyzine Pamoate33 in 1 BOTTLECAPSULE333

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3909HYDROXYZINE PAMOATE CAPSULE [A-S MEDICATION SOLUTIONS]3Legacy NDC, 1 package rows20190502_b450ec67-4217-4627-9265-0a416f6c7e28.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995278hydrOXYzine pamoate 50 MG Oral CapsulePSNb450ec67-4217-4627-9265-0a416f6c7e283
995278hydroxyzine pamoate 50 MG Oral CapsuleSCDb450ec67-4217-4627-9265-0a416f6c7e283
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSYb450ec67-4217-4627-9265-0a416f6c7e283

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3909-05009039090033 CAPSULE in 1 BOTTLE (50090-3909-0) 33 capsule2018-12-050000-00-00NoNoCurrent