FDA.reportPublic FDA data

Hydroxyzine hydrochloride

Product NDC
53002-3901
11-digit product format
530023901
Labeler code
53002
Product ID
53002-3901_28053007-d310-4068-bf75-80451033d0e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA204279
Marketing category
ANDA
Marketing start
2014-08-20
Marketing end
0000-00-00
Substance
HYDROXYZINE HYDROCHLORIDE
Active strength
10 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
53002-3901-12023-01-30C16284748780-1f386c649-cdf2-0266-e053-dadaa90a7c1aRx only
53002-3901-22023-01-30C16284748780-1f386c649-cdf2-0266-e053-dadaa90a7c1aRx only
53002-3901-32023-01-30C16284748780-1f386c649-cdf2-0266-e053-dadaa90a7c1aRx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-3901-1Hydroxyzine hydrochloride10 in 1 BOTTLETABLET101
53002-3901-2Hydroxyzine hydrochloride20 in 1 BOTTLETABLET201
53002-3901-3Hydroxyzine hydrochloride30 in 1 BOTTLETABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-3901HYDROXYZINE HYDROCHLORIDE TABLET [RPK PHARMACEUTICALS, INC.]1Legacy NDC, 3 package rows20201222_b26442f9-f577-4bad-b74c-4afca47ce9bd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995218hydrOXYzine HCl 10 MG Oral TabletPSNb26442f9-f577-4bad-b74c-4afca47ce9bd1
995218hydroxyzine hydrochloride 10 MG Oral TabletSCDb26442f9-f577-4bad-b74c-4afca47ce9bd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-3901-15300239010110 TABLET in 1 BOTTLE (53002-3901-1) 10 tablet2020-01-010000-00-00NoNoCurrent
53002-3901-25300239010220 TABLET in 1 BOTTLE (53002-3901-2) 20 tablet2020-01-010000-00-00NoNoCurrent
53002-3901-35300239010330 TABLET in 1 BOTTLE (53002-3901-3) 30 tablet2020-01-010000-00-00NoNoCurrent