FDA.reportPublic FDA data

Hydroxyzine Hydrochloride

Product NDC
71335-0961
11-digit product format
713350961
Labeler code
71335
Product ID
71335-0961_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
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, 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
71335-0961-1Hydroxyzine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED3014
71335-0961-2Hydroxyzine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED10014
71335-0961-3Hydroxyzine Hydrochloride20 in 1 BOTTLETABLET, FILM COATED2014
71335-0961-4Hydroxyzine Hydrochloride90 in 1 BOTTLETABLET, FILM COATED9014
71335-0961-5Hydroxyzine Hydrochloride15 in 1 BOTTLETABLET, FILM COATED1514
71335-0961-6Hydroxyzine Hydrochloride60 in 1 BOTTLETABLET, FILM COATED6014
71335-0961-7Hydroxyzine Hydrochloride120 in 1 BOTTLETABLET, FILM COATED12014
71335-0961-8Hydroxyzine Hydrochloride10 in 1 BOTTLETABLET, FILM COATED1014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0961HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]13Current NDC, Legacy NDC, 8 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
71335-0961-17133509610130 TABLET, FILM COATED in 1 BOTTLE (71335-0961-1) 2018-10-050000-00-00NoNoCurrent
71335-0961-271335096102100 TABLET, FILM COATED in 1 BOTTLE (71335-0961-2) 2018-10-050000-00-00NoNoCurrent
71335-0961-37133509610320 TABLET, FILM COATED in 1 BOTTLE (71335-0961-3) 2018-10-050000-00-00NoNoCurrent
71335-0961-47133509610490 TABLET, FILM COATED in 1 BOTTLE (71335-0961-4) 2018-10-050000-00-00NoNoCurrent
71335-0961-57133509610515 TABLET, FILM COATED in 1 BOTTLE (71335-0961-5) 2018-10-050000-00-00NoNoCurrent
71335-0961-67133509610660 TABLET, FILM COATED in 1 BOTTLE (71335-0961-6) 2018-10-050000-00-00NoNoCurrent
71335-0961-771335096107120 TABLET, FILM COATED in 1 BOTTLE (71335-0961-7) 2018-10-050000-00-00NoNoCurrent
71335-0961-87133509610810 TABLET, FILM COATED in 1 BOTTLE (71335-0961-8) 2018-10-050000-00-00NoNoCurrent