FDA.reportPublic FDA data

Hydroxyzine Hydrochloride

Product NDC
71335-0246
11-digit product format
713350246
Labeler code
71335
Product ID
71335-0246_8a3da07e-0bfc-4d10-9dd9-11a19486fff7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA088619
Marketing category
ANDA
Marketing start
2012-10-22
Substance
HYDROXYZINE DIHYDROCHLORIDE
Active strength
50 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 DIHYDROCHLORIDE50 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
71335-0246-1Hydroxyzine Hydrochloride120 in 1 BOTTLETABLET, FILM COATED12014
71335-0246-2Hydroxyzine Hydrochloride20 in 1 BOTTLETABLET, FILM COATED2014
71335-0246-3Hydroxyzine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED3014
71335-0246-4Hydroxyzine Hydrochloride60 in 1 BOTTLETABLET, FILM COATED6014
71335-0246-5Hydroxyzine Hydrochloride90 in 1 BOTTLETABLET, FILM COATED9014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0246-1EA - Each71335-024670ec13f9-37a5-4afd-a1ac-94ccdfb563bc12018-03-08
71335-0246-2EA - Each71335-0246ac362b7c-585b-4483-9149-feaa5600156512018-03-08
71335-0246-3EA - Each71335-0246531fd487-9e6f-4b83-b802-2f4166bd564a12018-03-08
71335-0246-4EA - Each71335-0246879d2d65-a28f-448c-9c52-3c4ad95515d412018-03-08
71335-0246-5EA - Each71335-024677b1539f-35d9-4ae2-a608-e57eb0f0e26512018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0246HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]13Current NDC, Legacy NDC, 5 package rows20231130_93d117dd-e2bf-4daa-abe3-d4fefed3313c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995218hydrOXYzine HCl 10 MG Oral TabletPSN93d117dd-e2bf-4daa-abe3-d4fefed3313c14
995258hydrOXYzine HCl 25 MG Oral TabletPSN93d117dd-e2bf-4daa-abe3-d4fefed3313c14
995281hydrOXYzine HCl 50 MG Oral TabletPSN93d117dd-e2bf-4daa-abe3-d4fefed3313c14
995218hydroxyzine hydrochloride 10 MG Oral TabletSCD93d117dd-e2bf-4daa-abe3-d4fefed3313c14
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD93d117dd-e2bf-4daa-abe3-d4fefed3313c14
995281hydroxyzine hydrochloride 50 MG Oral TabletSCD93d117dd-e2bf-4daa-abe3-d4fefed3313c14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0246-171335024601120 TABLET, FILM COATED in 1 BOTTLE (71335-0246-1) 2017-10-040000-00-00NoNoCurrent
71335-0246-27133502460220 TABLET, FILM COATED in 1 BOTTLE (71335-0246-2) 2017-10-040000-00-00NoNoCurrent
71335-0246-37133502460330 TABLET, FILM COATED in 1 BOTTLE (71335-0246-3) 2017-10-040000-00-00NoNoCurrent
71335-0246-47133502460460 TABLET, FILM COATED in 1 BOTTLE (71335-0246-4) 2017-10-040000-00-00NoNoCurrent
71335-0246-57133502460590 TABLET, FILM COATED in 1 BOTTLE (71335-0246-5) 2017-10-040000-00-00NoNoCurrent