Hydroxyzine hydrochloride

Product NDC
53217-236
11-digit product format
532170236
Labeler code
53217
Product ID
53217-236_7ed7972f-86a0-4d18-a652-b5d954da94ac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA204279
Marketing category
ANDA
Marketing start
2012-03-24
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
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
53217-236-202020-01-31C16284748780-19d75b9d0-1936-f424-e053-dadaa90a57ceRx only
53217-236-302020-01-31C16284748780-19d75b9d0-1936-f424-e053-dadaa90a57ceRx only
53217-236-602020-01-31C16284748780-19d75b9d0-1936-f424-e053-dadaa90a57ceRx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-236-20Hydroxyzine hydrochloride20 in 1 BOTTLETABLET201
53217-236-30Hydroxyzine hydrochloride30 in 1 BOTTLETABLET301
53217-236-60Hydroxyzine hydrochloride60 in 1 BOTTLETABLET601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-236-20EA - Each53217-23626389c62-ac93-487f-911d-0b5576c0de3112017-03-06
53217-236-30EA - Each53217-236bd3594bf-2aa8-4e30-a868-112685dfc00712017-03-06
53217-236-60EA - Each53217-236ef214274-79d6-4909-923d-8b0b306769e212017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-236HYDROXYZINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 3 package rows20161222_2d752346-31e2-4e92-803f-f1e68c3dba1a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995218hydrOXYzine HCl 10 MG Oral TabletPSN2d752346-31e2-4e92-803f-f1e68c3dba1a1
995218hydroxyzine hydrochloride 10 MG Oral TabletSCD2d752346-31e2-4e92-803f-f1e68c3dba1a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-236-205321702362020 in 1 BOTTLEHistorical
53217-236-305321702363030 in 1 BOTTLEHistorical
53217-236-605321702366060 in 1 BOTTLEHistorical