FDA.reportPublic FDA data

Hydroxyzine HCL

Product NDC
80425-0173
11-digit product format
804250173
Labeler code
80425
Product ID
80425-0173_16edd342-ced2-eeb7-e063-6394a90a35ef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine HCL
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
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 HCL
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
80425-0173-1Hydroxyzine HCL30 in 1 BOTTLETABLET, FILM COATED304
80425-0173-2Hydroxyzine HCL60 in 1 BOTTLETABLET, FILM COATED604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0173-1EA - Each80425-0173189b2f12-a828-44bd-97c6-03bcf942b1f612023-06-06
80425-0173-2EA - Each80425-0173918f2b72-6f78-472c-8c98-5731318aa3b412024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0173HYDROXYZINE HCL TABLET, FILM COATED [ADVANCED RX PHARMACY OF TENNESSEE, LLC]4Current NDC, Legacy NDC, 2 package rows20240426_cd4ea0ea-0d92-b70c-e053-2995a90a62ce.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995281hydrOXYzine HCl 50 MG Oral TabletPSNcd4ea0ea-0d92-b70c-e053-2995a90a62ce4
995281hydroxyzine hydrochloride 50 MG Oral TabletSCDcd4ea0ea-0d92-b70c-e053-2995a90a62ce4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
80425-0173-18042501730130 TABLET, FILM COATED in 1 BOTTLE (80425-0173-1) 2013-02-190000-00-00NoNoCurrent
80425-0173-28042501730260 TABLET, FILM COATED in 1 BOTTLE (80425-0173-2) 2024-04-25NoNoCurrent