FDA.reportPublic FDA data

Hydroxyzine Hydrochloride

Product NDC
71335-2185
11-digit product format
713352185
Labeler code
71335
Product ID
71335-2185_380d3ff6-47d7-4cc3-8889-8fe07f78f894
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA040604
Marketing category
ANDA
Marketing start
2015-03-31
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
Rxcui995281

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
71335-2185-1Hydroxyzine Hydrochloride120 in 1 BOTTLETABLET, FILM COATED120102
71335-2185-2Hydroxyzine Hydrochloride20 in 1 BOTTLETABLET, FILM COATED20102
71335-2185-3Hydroxyzine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED30102
71335-2185-4Hydroxyzine Hydrochloride60 in 1 BOTTLETABLET, FILM COATED60102
71335-2185-5Hydroxyzine Hydrochloride90 in 1 BOTTLETABLET, FILM COATED90102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2185-4EA - Each71335-2185f734042e-0549-4540-a3e0-242106bc4a9612023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2185HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 5 package rows20240420_f6f688d0-cb13-40af-a65f-480c37334e37.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995281hydrOXYzine HCl 50 MG Oral TabletPSNf6f688d0-cb13-40af-a65f-480c37334e37102
995281hydroxyzine hydrochloride 50 MG Oral TabletSCDf6f688d0-cb13-40af-a65f-480c37334e37102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-2185-171335218501120 TABLET, FILM COATED in 1 BOTTLE (71335-2185-1) 2024-04-030000-00-00NoNoCurrent
71335-2185-27133521850220 TABLET, FILM COATED in 1 BOTTLE (71335-2185-2) 2024-04-030000-00-00NoNoCurrent
71335-2185-37133521850330 TABLET, FILM COATED in 1 BOTTLE (71335-2185-3) 2023-01-240000-00-00NoNoCurrent
71335-2185-47133521850460 TABLET, FILM COATED in 1 BOTTLE (71335-2185-4) 2022-11-290000-00-00NoNoCurrent
71335-2185-57133521850590 TABLET, FILM COATED in 1 BOTTLE (71335-2185-5) 2024-04-030000-00-00NoNoCurrent