FDA.reportPublic FDA data

Hydroxyzine hydrochloride

Product NDC
71335-2340
11-digit product format
713352340
Labeler code
71335
Product ID
71335-2340_88944472-0417-47b5-8d01-fc2aad48a884
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA204279
Marketing category
ANDA
Marketing start
2014-08-20
Substance
HYDROXYZINE DIHYDROCHLORIDE
Active strength
25 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 DIHYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii76755771U3
Rxcui995258

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
71335-2340-1Hydroxyzine hydrochloride30 in 1 BOTTLETABLET30102
71335-2340-2Hydroxyzine hydrochloride60 in 1 BOTTLETABLET60102
71335-2340-3Hydroxyzine hydrochloride20 in 1 BOTTLETABLET20102
71335-2340-4Hydroxyzine hydrochloride100 in 1 BOTTLETABLET100102
71335-2340-5Hydroxyzine hydrochloride15 in 1 BOTTLETABLET15102
71335-2340-6Hydroxyzine hydrochloride90 in 1 BOTTLETABLET90102
71335-2340-7Hydroxyzine hydrochloride19 in 1 BOTTLETABLET19102
71335-2340-8Hydroxyzine hydrochloride10 in 1 BOTTLETABLET10102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2340HYDROXYZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]101Current NDC, 8 package rows20240504_e4c60e14-28c7-46e2-9fdc-b1a1ce54f3c2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995258hydrOXYzine HCl 25 MG Oral TabletPSNe4c60e14-28c7-46e2-9fdc-b1a1ce54f3c2102
995258hydroxyzine hydrochloride 25 MG Oral TabletSCDe4c60e14-28c7-46e2-9fdc-b1a1ce54f3c2102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2340-17133523400130 TABLET in 1 BOTTLE (71335-2340-1) 30 tablet2025-06-27NoNoHistorical
71335-2340-27133523400260 TABLET in 1 BOTTLE (71335-2340-2) 60 tablet2025-06-27NoNoHistorical
71335-2340-37133523400320 TABLET in 1 BOTTLE (71335-2340-3) 20 tablet2025-06-27NoNoHistorical
71335-2340-471335234004100 TABLET in 1 BOTTLE (71335-2340-4) 100 tablet2025-06-27NoNoHistorical
71335-2340-57133523400515 TABLET in 1 BOTTLE (71335-2340-5) 15 tablet2025-06-27NoNoHistorical
71335-2340-67133523400690 TABLET in 1 BOTTLE (71335-2340-6) 90 tablet2025-06-27NoNoHistorical
71335-2340-77133523400719 TABLET in 1 BOTTLE (71335-2340-7) 19 tablet2025-06-27NoNoHistorical
71335-2340-87133523400810 TABLET in 1 BOTTLE (71335-2340-8) 10 tablet2025-06-27NoNoHistorical