Hydroxyzine hydrochloride

Product NDC
50436-0501
11-digit product format
504360501
Labeler code
50436
Product ID
50436-0501_2d901ec5-a4de-491a-8d9b-02f04af15a13
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA204279
Marketing category
ANDA
Marketing start
2012-03-24
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
50436-0501-12021-01-29C16284748780-1ba0f9c33-57ae-a910-e053-dadaa90a0b85Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-0501-1Hydroxyzine hydrochloride30 in 1 BOTTLETABLET302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0501HYDROXYZINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]2Legacy NDC, 1 package rows20190213_4f32ed01-7470-4909-afe4-7831a5bd90bb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995258hydrOXYzine HCl 25 MG Oral TabletPSN4f32ed01-7470-4909-afe4-7831a5bd90bb2
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD4f32ed01-7470-4909-afe4-7831a5bd90bb2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-0501-15043605010130 in 1 BOTTLEHistorical