FDA.reportPublic FDA data

Hydroxyzine hydrochloride

Product NDC
23155-500
11-digit product format
231550500
Labeler code
23155
Product ID
23155-500_2be52341-592e-4a89-acc0-730b0560b132
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA204279
Marketing category
ANDA
Marketing start
2014-08-20
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, 995258, 995281

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
23155-500-012020-03-26C16284748780-19d75b9cf-fad0-f424-e053-dadaa90a57ceRx only
23155-500-052020-03-26C16284748780-19d75b9cf-fad0-f424-e053-dadaa90a57ceRx only
23155-500-102020-03-26C16284748780-19d75b9cf-fad0-f424-e053-dadaa90a57ceRx only
23155-500-012020-01-31C16284748780-19d75b9cf-fad0-f424-e053-dadaa90a57ceRx only
23155-500-052020-01-31C16284748780-19d75b9cf-fad0-f424-e053-dadaa90a57ceRx only
23155-500-102020-01-31C16284748780-19d75b9cf-fad0-f424-e053-dadaa90a57ceRx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
23155-500-01Hydroxyzine hydrochloride100 in 1 BOTTLETABLET10022
23155-500-05Hydroxyzine hydrochloride500 in 1 BOTTLETABLET50022
23155-500-10Hydroxyzine hydrochloride1000 in 1 BOTTLETABLET100022
23155-500-18Hydroxyzine hydrochloride108000 in 1 CONTAINERTABLET10800022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-500-01EA - Each23155-500912b07ac-2512-4743-91dc-169d8c48a21b12015-11-12
23155-500-05EA - Each23155-5002c9d5353-9015-4b93-a58d-0c8aa3078c5b12015-11-12
23155-500-10EA - Each23155-50065209e8d-ac27-45c5-8258-67c57a77289612015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROXYZINE HYDROCHLORIDEACTIVE INGREDIENT76755771U3HYDROXYZINE HYDROCHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC.]7
HYDROXYZINEACTIVE MOIETY30S50YM8OGHYDROXYZINE HYDROCHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC.]7
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKHYDROXYZINE HYDROCHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC.]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROXYZINE HYDROCHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC.]7
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYDROXYZINE HYDROCHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC.]7
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOHYDROXYZINE HYDROCHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC.]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROXYZINE HYDROCHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC.]7
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AHYDROXYZINE HYDROCHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC.]7
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HHYDROXYZINE HYDROCHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC.]7
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROXYZINE HYDROCHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC.]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROXYZINE HYDROCHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC.]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-500HYDROXYZINE HYDROCHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]22Current NDC, Legacy NDC, 4 package rows20250519_f9ff4b7c-dc81-47af-8371-5c681eb0d876.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995218hydrOXYzine HCl 10 MG Oral TabletPSNb52e1759-8be3-4e46-a891-4eaa9270c42128
995258hydrOXYzine HCl 25 MG Oral TabletPSNb52e1759-8be3-4e46-a891-4eaa9270c42128
995218hydroxyzine hydrochloride 10 MG Oral TabletSCDb52e1759-8be3-4e46-a891-4eaa9270c42128
995258hydroxyzine hydrochloride 25 MG Oral TabletSCDb52e1759-8be3-4e46-a891-4eaa9270c42128
995218hydrOXYzine HCl 10 MG Oral TabletPSN0c687cbe-ce40-4bc0-b880-5166b5be7a8024
995258hydrOXYzine HCl 25 MG Oral TabletPSN0c687cbe-ce40-4bc0-b880-5166b5be7a8024
995281hydrOXYzine HCl 50 MG Oral TabletPSN0c687cbe-ce40-4bc0-b880-5166b5be7a8024
995218hydroxyzine hydrochloride 10 MG Oral TabletSCD0c687cbe-ce40-4bc0-b880-5166b5be7a8024
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD0c687cbe-ce40-4bc0-b880-5166b5be7a8024
995281hydroxyzine hydrochloride 50 MG Oral TabletSCD0c687cbe-ce40-4bc0-b880-5166b5be7a8024
995218hydrOXYzine HCl 10 MG Oral TabletPSNf9ff4b7c-dc81-47af-8371-5c681eb0d87622
995258hydrOXYzine HCl 25 MG Oral TabletPSNf9ff4b7c-dc81-47af-8371-5c681eb0d87622
995281hydrOXYzine HCl 50 MG Oral TabletPSNf9ff4b7c-dc81-47af-8371-5c681eb0d87622
995218hydroxyzine hydrochloride 10 MG Oral TabletSCDf9ff4b7c-dc81-47af-8371-5c681eb0d87622
995258hydroxyzine hydrochloride 25 MG Oral TabletSCDf9ff4b7c-dc81-47af-8371-5c681eb0d87622
995281hydroxyzine hydrochloride 50 MG Oral TabletSCDf9ff4b7c-dc81-47af-8371-5c681eb0d87622
995218hydrOXYzine HCl 10 MG Oral TabletPSN71eea118-395c-4559-aed5-900b635674b89
995218hydroxyzine hydrochloride 10 MG Oral TabletSCD71eea118-395c-4559-aed5-900b635674b89
995218hydrOXYzine HCl 10 MG Oral TabletPSN2562692e-e9cc-4f81-bdc9-47b7d42337587
995218hydroxyzine hydrochloride 10 MG Oral TabletSCD2562692e-e9cc-4f81-bdc9-47b7d42337587
995218hydrOXYzine HCl 10 MG Oral TabletPSNc134195e-a048-530a-e053-2a95a90ad9f84
995218hydrOXYzine HCl 10 MG Oral TabletPSN7f76580c-96a0-4b56-8986-ff5488bb98694
995258hydrOXYzine HCl 25 MG Oral TabletPSN7f76580c-96a0-4b56-8986-ff5488bb98694
995281hydrOXYzine HCl 50 MG Oral TabletPSN7f76580c-96a0-4b56-8986-ff5488bb98694
995218hydroxyzine hydrochloride 10 MG Oral TabletSCD7f76580c-96a0-4b56-8986-ff5488bb98694
995218hydroxyzine hydrochloride 10 MG Oral TabletSCDc134195e-a048-530a-e053-2a95a90ad9f84
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD7f76580c-96a0-4b56-8986-ff5488bb98694
995281hydroxyzine hydrochloride 50 MG Oral TabletSCD7f76580c-96a0-4b56-8986-ff5488bb98694
995218hydrOXYzine HCl 10 MG Oral TabletPSNd956063a-ef48-faca-e053-2995a90a02913
995218hydroxyzine hydrochloride 10 MG Oral TabletSCDd956063a-ef48-faca-e053-2995a90a02913
995218hydrOXYzine HCl 10 MG Oral TabletPSN2fc9b08a-e675-dbc5-e063-6294a90ad0542
995218hydrOXYzine HCl 10 MG Oral TabletPSN2da6dd2f-90e2-464a-ad2a-292575cb04282
995258hydrOXYzine HCl 25 MG Oral TabletPSN2fc9b08a-e675-dbc5-e063-6294a90ad0542
995281hydrOXYzine HCl 50 MG Oral TabletPSN2fc9b08a-e675-dbc5-e063-6294a90ad0542
995218hydroxyzine hydrochloride 10 MG Oral TabletSCD2fc9b08a-e675-dbc5-e063-6294a90ad0542
995218hydroxyzine hydrochloride 10 MG Oral TabletSCD2da6dd2f-90e2-464a-ad2a-292575cb04282
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD2fc9b08a-e675-dbc5-e063-6294a90ad0542
995281hydroxyzine hydrochloride 50 MG Oral TabletSCD2fc9b08a-e675-dbc5-e063-6294a90ad0542
995218hydrOXYzine HCl 10 MG Oral TabletPSNb26442f9-f577-4bad-b74c-4afca47ce9bd1
995218hydrOXYzine HCl 10 MG Oral TabletPSN2d752346-31e2-4e92-803f-f1e68c3dba1a1
995218hydrOXYzine HCl 10 MG Oral TabletPSN4f3266f4-00a6-4c0c-bff2-e606913de8941
995258hydrOXYzine HCl 25 MG Oral TabletPSN4f3266f4-00a6-4c0c-bff2-e606913de8941
995281hydrOXYzine HCl 50 MG Oral TabletPSN4f3266f4-00a6-4c0c-bff2-e606913de8941
995218hydroxyzine hydrochloride 10 MG Oral TabletSCD2d752346-31e2-4e92-803f-f1e68c3dba1a1
995218hydroxyzine hydrochloride 10 MG Oral TabletSCDb26442f9-f577-4bad-b74c-4afca47ce9bd1
995218hydroxyzine hydrochloride 10 MG Oral TabletSCD4f3266f4-00a6-4c0c-bff2-e606913de8941
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD4f3266f4-00a6-4c0c-bff2-e606913de8941
995281hydroxyzine hydrochloride 50 MG Oral TabletSCD4f3266f4-00a6-4c0c-bff2-e606913de8941

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23155-500-0123155050001100 TABLET in 1 BOTTLE (23155-500-01) 100 tablet2014-08-200000-00-00NoNoCurrent
23155-500-0523155050005500 TABLET in 1 BOTTLE (23155-500-05) 500 tablet2014-08-200000-00-00NoNoCurrent
23155-500-10231550500101000 TABLET in 1 BOTTLE (23155-500-10) 1000 tablet2014-08-200000-00-00NoNoCurrent
23155-500-1823155050018108000 in 1 CONTAINERHistorical