Hydroxyzine hydrochloride

Product NDC
67296-1532
11-digit product format
672961532
Labeler code
67296
Product ID
67296-1532_d61bc1c5-8574-09f3-e053-2a95a90a2fad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA204279
Marketing category
ANDA
Marketing start
2012-03-24
Marketing end
0000-00-00
Substance
HYDROXYZINE DIHYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
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
67296-1532-32024-08-08C16284748780-11030e365-2948-111a-e063-dadaa90a10e2hydroxyzine hcl 25mg
67296-1532-32024-01-30C16284748780-11030e365-2948-111a-e063-dadaa90a10e2hydroxyzine hcl 25mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1532-3Hydroxyzine hydrochloride30 in 1 BOTTLETABLET306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1532HYDROXYZINE HYDROCHLORIDE TABLET [REDPHARM DRUG, INC.]6Legacy NDC, 1 package rows20240809_57e9cb6c-4718-7821-e053-2991aa0afa6b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995258hydrOXYzine HCl 25 MG Oral TabletPSN57e9cb6c-4718-7821-e053-2991aa0afa6b6
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD57e9cb6c-4718-7821-e053-2991aa0afa6b6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1532-36729615320330 TABLET in 1 BOTTLE (67296-1532-3) 30 tablet2012-03-240000-00-00NoNoCurrent