FDA.reportPublic FDA data

Hydroxyzine hydrochloride

Product NDC
67046-279
11-digit product format
670460279
Labeler code
67046
Product ID
67046-279_5a92df4e-30b3-b295-e053-2991aa0ab4a9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA204279
Marketing category
ANDA
Marketing start
2017-10-02
Marketing end
0000-00-00
Substance
HYDROXYZINE HYDROCHLORIDE
Active strength
50 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
67046-279-072020-01-31C16284748780-19d75b9d0-b890-f424-e053-dadaa90a57ce279 Hydroxyzine 50 mg Rx only
67046-279-142020-01-31C16284748780-19d75b9d0-b890-f424-e053-dadaa90a57ce279 Hydroxyzine 50 mg Rx only
67046-279-152020-01-31C16284748780-19d75b9d0-b890-f424-e053-dadaa90a57ce279 Hydroxyzine 50 mg Rx only
67046-279-202020-01-31C16284748780-19d75b9d0-b890-f424-e053-dadaa90a57ce279 Hydroxyzine 50 mg Rx only
67046-279-212020-01-31C16284748780-19d75b9d0-b890-f424-e053-dadaa90a57ce279 Hydroxyzine 50 mg Rx only
67046-279-282020-01-31C16284748780-19d75b9d0-b890-f424-e053-dadaa90a57ce279 Hydroxyzine 50 mg Rx only
67046-279-302020-01-31C16284748780-19d75b9d0-b890-f424-e053-dadaa90a57ce279 Hydroxyzine 50 mg Rx only
67046-279-602020-01-31C16284748780-19d75b9d0-b890-f424-e053-dadaa90a57ce279 Hydroxyzine 50 mg Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-279-07Hydroxyzine hydrochloride7 in 1 BLISTER PACKTABLET71
67046-279-14Hydroxyzine hydrochloride14 in 1 BLISTER PACKTABLET141
67046-279-15Hydroxyzine hydrochloride15 in 1 BLISTER PACKTABLET151
67046-279-20Hydroxyzine hydrochloride20 in 1 BLISTER PACKTABLET201
67046-279-21Hydroxyzine hydrochloride21 in 1 BLISTER PACKTABLET211
67046-279-28Hydroxyzine hydrochloride28 in 1 BLISTER PACKTABLET281
67046-279-30Hydroxyzine hydrochloride30 in 1 BLISTER PACKTABLET301
67046-279-60Hydroxyzine hydrochloride60 in 1 BLISTER PACKTABLET601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-279HYDROXYZINE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 8 package rows20171002_5a92df4e-30b4-b295-e053-2991aa0ab4a9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995281hydrOXYzine HCl 50 MG Oral TabletPSN5a92df4e-30b4-b295-e053-2991aa0ab4a91
995281hydroxyzine hydrochloride 50 MG Oral TabletSCD5a92df4e-30b4-b295-e053-2991aa0ab4a91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67046-279-07670460279077 in 1 BLISTER PACKHistorical
67046-279-146704602791414 in 1 BLISTER PACKHistorical
67046-279-156704602791515 in 1 BLISTER PACKHistorical
67046-279-206704602792020 in 1 BLISTER PACKHistorical
67046-279-216704602792121 in 1 BLISTER PACKHistorical
67046-279-286704602792828 in 1 BLISTER PACKHistorical
67046-279-306704602793030 in 1 BLISTER PACKHistorical
67046-279-606704602796060 in 1 BLISTER PACKHistorical