HydrOXYzine Hydrochloride

Product NDC
68071-2864
11-digit product format
680712864
Labeler code
68071
Product ID
68071-2864_ebf3edb9-898d-1dcc-e053-2995a90a911b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HydrOXYzine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA040840
Marketing category
ANDA
Marketing start
2009-11-11
Marketing end
0000-00-00
Substance
HYDROXYZINE DIHYDROCHLORIDE
Active strength
10 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
68071-2864-32025-01-30C16284748780-12cef2736-7f99-d83d-e063-dadaa90ab31fRx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2864-3HydrOXYzine Hydrochloride30 in 1 BOTTLETABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2864HYDROXYZINE HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 1 package rows20221029_ebf3edb9-898c-1dcc-e053-2995a90a911b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995218hydrOXYzine HCl 10 MG Oral TabletPSNebf3edb9-898c-1dcc-e053-2995a90a911b1
995218hydroxyzine hydrochloride 10 MG Oral TabletSCDebf3edb9-898c-1dcc-e053-2995a90a911b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2864-36807128640330 TABLET in 1 BOTTLE (68071-2864-3) 30 tablet2022-10-260000-00-00NoNoCurrent