FDA.reportPublic FDA data

Hydroxyzine Hydrochloride

Product NDC
59651-500
11-digit product format
596510500
Labeler code
59651
Product ID
59651-500_86a715f8-fbfb-4d28-a144-27581d6aa1bb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA087871
Marketing category
ANDA
Marketing start
2021-10-07
Substance
HYDROXYZINE DIHYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hydroxyzine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROXYZINE DIHYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii76755771U3
Rxcui995218, 995258, 995281

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59651-500-01Hydroxyzine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1002
59651-500-05Hydroxyzine Hydrochloride500 in 1 BOTTLETABLET, FILM COATED5002
59651-500-99Hydroxyzine Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-500-01EA - Each59651-500b2d77229-4342-451d-bc44-79e714cd4f5612023-09-05
59651-500-05EA - Each59651-50092b9842d-0aa0-4289-bb63-896903e2c4bb12023-09-05
59651-500-99EA - Each59651-50072d20174-f3f9-4782-81bd-3aed89954d7c12024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-500HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]1Current NDC, Legacy NDC, 3 package rows20220811_9de2de56-614f-4294-8794-d30758cf5f70.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995258hydrOXYzine HCl 25 MG Oral TabletPSNe4e6a91d-f10b-4d85-a526-4c6192ea85dc100
995258hydrOXYzine HCl 25 MG Oral TabletPSNf84e3365-57d2-4904-9275-96600f8d74c7100
995258hydroxyzine hydrochloride 25 MG Oral TabletSCDe4e6a91d-f10b-4d85-a526-4c6192ea85dc100
995258hydroxyzine hydrochloride 25 MG Oral TabletSCDf84e3365-57d2-4904-9275-96600f8d74c7100
995218hydrOXYzine HCl 10 MG Oral TabletPSN9de2de56-614f-4294-8794-d30758cf5f702
995258hydrOXYzine HCl 25 MG Oral TabletPSN9de2de56-614f-4294-8794-d30758cf5f702
995281hydrOXYzine HCl 50 MG Oral TabletPSN9de2de56-614f-4294-8794-d30758cf5f702
995218hydroxyzine hydrochloride 10 MG Oral TabletSCD9de2de56-614f-4294-8794-d30758cf5f702
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD9de2de56-614f-4294-8794-d30758cf5f702
995281hydroxyzine hydrochloride 50 MG Oral TabletSCD9de2de56-614f-4294-8794-d30758cf5f702
995258hydrOXYzine HCl 25 MG Oral TabletPSNeef36dab-c318-44d2-8583-7bae3bfceee71
995258hydroxyzine hydrochloride 25 MG Oral TabletSCDeef36dab-c318-44d2-8583-7bae3bfceee71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59651-500-0159651050001100 TABLET, FILM COATED in 1 BOTTLE (59651-500-01) 2021-10-070000-00-00NoNoCurrent
59651-500-0559651050005500 TABLET, FILM COATED in 1 BOTTLE (59651-500-05) 2021-10-070000-00-00NoNoCurrent
59651-500-99596510500991000 TABLET, FILM COATED in 1 BOTTLE (59651-500-99) 2021-10-070000-00-00NoNoCurrent