FDA.reportPublic FDA data

Hydroxyzine Hydrochloride

Product NDC
72162-1332
Requested package NDC
72162-1332-3
11-digit product format
721621332
Labeler code
72162
Product ID
72162-1332_7adc75c5-71d2-48c2-9137-62e4533c7aed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA040600
Marketing category
ANDA
Marketing start
2015-03-31
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

Source provenance: Browse the complete Orange Book source catalog.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
76755771U3Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
995218Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
dd9e5dc5-720c-4de8-abae-6404c31f341fAvailable on FDA.report

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
72162-1332-3Hydroxyzine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED30102
72162-1332-9Hydroxyzine Hydrochloride90 in 1 BOTTLETABLET, FILM COATED90102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1332-3EA - Each72162-133274e87662-a1f1-4771-ab00-0e68f8baddfb12023-10-16
72162-1332-9EA - Each72162-1332f9b01d0c-36b8-4487-9f70-8b29acba33fe12023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1332HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]102Current NDC, 2 package rows20250409_dd9e5dc5-720c-4de8-abae-6404c31f341f.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.413a39ce-98d6-40f5-9048-ad464e98de442026-05-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040600
application number: ANDA040600
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEBryant Ranch Prepackdd9e5dc5-720c-4de8-abae-6404c31f341f2025-03-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040600
application number: ANDA040600
ndc (package): 72162-1332-3
ndc (product): 72162-1332
ndc11 (package): 72162133203
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEBryant Ranch Prepack1c7d31fb-5e3c-456e-be6c-a3baafe60c372024-04-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040600
application number: ANDA040600

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995218hydrOXYzine HCl 10 MG Oral TabletPSNdd9e5dc5-720c-4de8-abae-6404c31f341f102
995218hydroxyzine hydrochloride 10 MG Oral TabletSCDdd9e5dc5-720c-4de8-abae-6404c31f341f102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-1332-37216213320330 TABLET, FILM COATED in 1 BOTTLE (72162-1332-3) 2024-04-08NoNoCurrent