FDA.reportPublic FDA data

Hydroxyzine Hydrochloride

Product NDC
50090-3362
11-digit product format
500903362
Labeler code
50090
Product ID
50090-3362_b85f46fe-45ee-4577-9a75-9cab3e742b84
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA088618
Marketing category
ANDA
Marketing start
2012-10-09
Marketing end
0000-00-00
Substance
HYDROXYZINE HYDROCHLORIDE
Active strength
25 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
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
50090-3362-02023-01-30C16284748780-1f386c649-bc10-0266-e053-dadaa90a7c1aHydrOXYzine Hydrochloride Tablets USP
50090-3362-12023-01-30C16284748780-1f386c649-bc10-0266-e053-dadaa90a7c1aHydrOXYzine Hydrochloride Tablets USP
50090-3362-42023-01-30C16284748780-1f386c649-bc10-0266-e053-dadaa90a7c1aHydrOXYzine Hydrochloride Tablets USP
50090-3362-62023-01-30C16284748780-1f386c649-bc10-0266-e053-dadaa90a7c1aHydrOXYzine Hydrochloride Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3362-0Hydroxyzine Hydrochloride20 in 1 BOTTLETABLET, FILM COATED201
50090-3362-1Hydroxyzine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED301
50090-3362-4Hydroxyzine Hydrochloride60 in 1 BOTTLETABLET, FILM COATED601
50090-3362-6Hydroxyzine Hydrochloride15 in 1 BOTTLETABLET, FILM COATED151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3362HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]1Legacy NDC, 4 package rows20190205_0dfe1d68-ba49-4435-8a51-33af47580c45.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995258hydrOXYzine HCl 25 MG Oral TabletPSN0dfe1d68-ba49-4435-8a51-33af47580c451
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD0dfe1d68-ba49-4435-8a51-33af47580c451

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3362-05009033620020 TABLET, FILM COATED in 1 BOTTLE (50090-3362-0) 2018-05-170000-00-00NoNoCurrent
50090-3362-15009033620130 TABLET, FILM COATED in 1 BOTTLE (50090-3362-1) 2018-02-060000-00-00NoNoCurrent
50090-3362-45009033620460 TABLET, FILM COATED in 1 BOTTLE (50090-3362-4) 2018-02-120000-00-00NoNoCurrent
50090-3362-65009033620615 TABLET, FILM COATED in 1 BOTTLE (50090-3362-6) 2018-02-220000-00-00NoNoCurrent