FDA.reportPublic FDA data

Hydroxyzine Hydrochloride

Product NDC
72162-2513
11-digit product format
721622513
Labeler code
72162
Product ID
72162-2513_c8cab0b8-d63c-4e62-b95e-c174b0b663c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA087871
Marketing category
ANDA
Marketing start
2021-10-07
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
72162-2513-0Hydroxyzine Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED1000100
72162-2513-1Hydroxyzine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED100100
72162-2513-5Hydroxyzine Hydrochloride500 in 1 BOTTLETABLET, FILM COATED500100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2513-0EA - Each72162-251300fa2af4-d5f1-4bea-851f-328260eea79612025-07-08
72162-2513-1EA - Each72162-25137c420860-4d03-4fb8-b666-92b47a8a81c312025-07-08
72162-2513-5EA - Each72162-2513e7c39b82-49c0-4e43-9d83-c27ce3cb25a412025-07-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2513HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]100Current NDC, 3 package rows20250525_a8c83479-f919-49f9-b125-747bd0e3211c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995281hydrOXYzine HCl 50 MG Oral TabletPSNa8c83479-f919-49f9-b125-747bd0e3211c100
995281hydroxyzine hydrochloride 50 MG Oral TabletSCDa8c83479-f919-49f9-b125-747bd0e3211c100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-2513-0721622513001000 TABLET, FILM COATED in 1 BOTTLE (72162-2513-0) 2025-05-23NoNoHistorical
72162-2513-172162251301100 TABLET, FILM COATED in 1 BOTTLE (72162-2513-1) 2025-05-23NoNoHistorical
72162-2513-572162251305500 TABLET, FILM COATED in 1 BOTTLE (72162-2513-5) 2025-05-23NoNoHistorical