Hydroxyzine hydrochloride

Product NDC
67046-713
11-digit product format
670460713
Labeler code
67046
Product ID
67046-713_a853a7bf-9824-e280-e053-2995a90a6a57
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
2020-06-15
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
67046-713-302022-01-28C16284748780-1d6a99b39-dc3c-a426-e053-dadaa90af4c2Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-713-30Hydroxyzine hydrochloride30 in 1 BLISTER PACKTABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-713HYDROXYZINE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 1 package rows20200619_a853a130-26f4-a657-e053-2995a90a2651.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995258hydrOXYzine HCl 25 MG Oral TabletPSNa853a130-26f4-a657-e053-2995a90a26511
995258hydroxyzine hydrochloride 25 MG Oral TabletSCDa853a130-26f4-a657-e053-2995a90a26511

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67046-713-306704607133030 TABLET in 1 BLISTER PACK (67046-713-30) 30 tablet2020-06-150000-00-00NoNoCurrent