FDA.reportPublic FDA data

HYDROXYZINE HYDROCHLORIDE

Product NDC
72189-333
11-digit product format
721890333
Labeler code
72189
Product ID
72189-333_40817dfb-a4b8-2d36-e063-6394a90ac107
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROXYZINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Direct Rx
Application
ANDA204279
Marketing category
ANDA
Marketing start
2022-03-03
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

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 Identifiers#

Field, Values table
FieldValues
Unii76755771U3
Rxcui995218

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
72189-333-30HYDROXYZINE HYDROCHLORIDE30 in 1 BOTTLETABLET303
72189-333-72HYDROXYZINE HYDROCHLORIDE120 in 1 BOTTLETABLET1203

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-333-30EA - Each72189-3333ccded96-ab92-4cf0-b5ba-4fe47632d00b12022-04-06
72189-333-72EA - Each72189-333c40ab6d7-2ce2-419f-b26b-eb9c7ec1911512025-11-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-333HYDROXYZINE HYDROCHLORIDE TABLET [DIRECT RX]2Current NDC, Legacy NDC, 2 package rows20250122_d956063a-ef48-faca-e053-2995a90a0291.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995218hydrOXYzine HCl 10 MG Oral TabletPSNd956063a-ef48-faca-e053-2995a90a02913
995218hydroxyzine hydrochloride 10 MG Oral TabletSCDd956063a-ef48-faca-e053-2995a90a02913

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72189-333-307218903333030 TABLET in 1 BOTTLE (72189-333-30) 30 tablet2022-03-030000-00-00NoNoCurrent
72189-333-7272189033372120 TABLET in 1 BOTTLE (72189-333-72) 120 tablet2022-03-03NoNoCurrent