Hydroxyzine Hydrochloride

Product NDC
67296-1681
11-digit product format
672961681
Labeler code
67296
Product ID
67296-1681_b8df9cca-bae5-58f5-e053-2a95a90af5e4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA088618
Marketing category
ANDA
Marketing start
2012-10-09
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
2022-12-31
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
67296-1681-32023-01-30C16284748780-1f386c649-d8e5-0266-e053-dadaa90a7c1ahydrox hcl 25mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1681-3Hydroxyzine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1681HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG, INC.]2Legacy NDC, 1 package rows20210115_96399093-415c-274b-e053-2a95a90a24b2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995258hydrOXYzine HCl 25 MG Oral TabletPSN96399093-415c-274b-e053-2a95a90a24b22
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD96399093-415c-274b-e053-2a95a90a24b22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67296-1681-36729616810330 TABLET, FILM COATED in 1 BOTTLE (67296-1681-3) 2019-10-310000-00-00NoNoCurrent