Hydroxyzine Hydrochloride

Product NDC
50436-3874
11-digit product format
504363874
Labeler code
50436
Product ID
50436-3874_4d9d861f-f48e-4c59-b6e8-22756387fb5d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA040804
Marketing category
ANDA
Marketing start
2008-06-30
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
2019-12-31
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
50436-3874-12020-01-31C16284748780-19d75b9d0-a432-f424-e053-dadaa90a57ceHYDROXYZINE HYDROCHLORIDE TABLETS, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-3874-1Hydroxyzine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-3874HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [UNIT DOSE SERVICES]2Legacy NDC, 1 package rows20160428_0f71b078-a957-47ed-a235-922c27c9a621.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995258hydrOXYzine HCl 25 MG Oral TabletPSN0f71b078-a957-47ed-a235-922c27c9a6212
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD0f71b078-a957-47ed-a235-922c27c9a6212

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-3874-15043638740130 in 1 BOTTLEHistorical