Hydroxyzine

Product NDC
10544-210
11-digit product format
105440210
Labeler code
10544
Product ID
10544-210_52b17351-bfe0-406f-9569-990cc7f00422
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA088618
Marketing category
ANDA
Marketing start
2010-05-17
Marketing end
0000-00-00
Substance
HYDROXYZINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Antihistamine [EPC],Histamine Receptor Antagonists [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
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
10544-210-202019-10-29C16284748780-1960f7f55-cc92-8e05-e053-dbdaa90a074aHYDROXYZINE HYDROCHLORIDE TABLETS USP
10544-210-302019-10-29C16284748780-1960f7f55-cc92-8e05-e053-dbdaa90a074aHYDROXYZINE HYDROCHLORIDE TABLETS USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-210-20Hydroxyzine20 in 1 BOTTLETABLET, FILM COATED201
10544-210-30Hydroxyzine30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-210HYDROXYZINE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1Legacy NDC, 2 package rows20101007_d794dece-8d16-4c53-a23b-d2006dc6e833.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995258hydrOXYzine HCl 25 MG Oral TabletPSNd794dece-8d16-4c53-a23b-d2006dc6e8331
995258hydroxyzine hydrochloride 25 MG Oral TabletSCDd794dece-8d16-4c53-a23b-d2006dc6e8331

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-210-201054402102020 in 1 BOTTLEHistorical
10544-210-301054402103030 in 1 BOTTLEHistorical