FDA.reportPublic FDA data

Hydroxyzine Hydrochloride

Product NDC
50090-4117
11-digit product format
500904117
Labeler code
50090
Product ID
50090-4117_1018a246-77e1-446e-b436-30feac311856
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA088617
Marketing category
ANDA
Marketing start
2013-02-19
Substance
HYDROXYZINE DIHYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hydroxyzine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROXYZINE DIHYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii76755771U3
Rxcui995218

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
50090-4117-02024-01-05C16284748780-1f386c649-e15d-0266-e053-dadaa90a7c1aHydrOXYzine Hydrochloride Tablets USP
50090-4117-32024-01-05C16284748780-1f386c649-e15d-0266-e053-dadaa90a7c1aHydrOXYzine Hydrochloride Tablets USP
50090-4117-02023-01-30C16284748780-1f386c649-e15d-0266-e053-dadaa90a7c1aHydrOXYzine Hydrochloride Tablets USP
50090-4117-32023-01-30C16284748780-1f386c649-e15d-0266-e053-dadaa90a7c1aHydrOXYzine Hydrochloride Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4117-0Hydroxyzine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED3013
50090-4117-3Hydroxyzine Hydrochloride20 in 1 BOTTLE, PLASTICTABLET, FILM COATED2013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4117-0EA - Each50090-4117ab0de529-5c46-424c-8628-33a17d1e3e5312021-11-09
50090-4117-3EA - Each50090-41172c61aaf8-7f8f-46b5-9c95-80b007bed70b12022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4117HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]13Current NDC, Legacy NDC, 2 package rows20240106_3946db7c-dc2d-4329-b9ac-f003d8c6d3e1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995218hydrOXYzine HCl 10 MG Oral TabletPSN3946db7c-dc2d-4329-b9ac-f003d8c6d3e113
995218hydroxyzine hydrochloride 10 MG Oral TabletSCD3946db7c-dc2d-4329-b9ac-f003d8c6d3e113

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4117-05009041170030 TABLET, FILM COATED in 1 BOTTLE (50090-4117-0) 2019-02-010000-00-00NoNoCurrent
50090-4117-35009041170320 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-4117-3) 2014-11-280000-00-00NoNoCurrent