Hydroxyzine Hydrochloride

Product NDC
67296-1293
11-digit product format
672961293
Labeler code
67296
Product ID
67296-1293_9c9f4448-d94f-9258-e053-2a95a90a532f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA040808
Marketing category
ANDA
Marketing start
2007-06-29
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
2021-12-31
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
67296-1293-32022-01-28C16284748780-1d6a99b39-8203-a426-e053-dadaa90af4c24fbf72e0-c7ea-0a50-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1293-3Hydroxyzine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1293HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG, INC.]3Legacy NDC, 1 package rows20200122_4fbf72e0-c7ea-0a50-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995258hydrOXYzine HCl 25 MG Oral TabletPSN4fbf72e0-c7ea-0a50-e054-00144ff8d46c3
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD4fbf72e0-c7ea-0a50-e054-00144ff8d46c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67296-1293-36729612930330 TABLET, FILM COATED in 1 BOTTLE (67296-1293-3) 2007-06-290000-00-00NoNoCurrent