Hydroxyzine Hydrochloride

Product NDC
50090-4404
11-digit product format
500904404
Labeler code
50090
Product ID
50090-4404_ee400dd7-3f8e-4b6b-8b34-d04d7a464cc8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
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
2020-12-31
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
50090-4404-02023-01-30C16284748780-1f386c64a-1abc-0266-e053-dadaa90a7c1aHydrOXYzine Hydrochloride Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4404-0Hydroxyzine Hydrochloride90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4404HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]2Legacy NDC, 1 package rows20190726_963e8380-8a29-4440-b946-6238011cc776.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995258hydrOXYzine HCl 25 MG Oral TabletPSN963e8380-8a29-4440-b946-6238011cc7762
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD963e8380-8a29-4440-b946-6238011cc7762

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4404-05009044040090 TABLET, FILM COATED in 1 BOTTLE (50090-4404-0) 2019-07-010000-00-00NoNoCurrent