FDA.reportPublic FDA data

Hydroxyzine hydrochloride

Product NDC
23155-502
11-digit product format
231550502
Labeler code
23155
Product ID
23155-502_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
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
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
23155-502-012020-03-26C16284748780-19d75b9cf-fad0-f424-e053-dadaa90a57ceRx only
23155-502-052020-03-26C16284748780-19d75b9cf-fad0-f424-e053-dadaa90a57ceRx only
23155-502-102020-03-26C16284748780-19d75b9cf-fad0-f424-e053-dadaa90a57ceRx only
23155-502-012020-01-31C16284748780-19d75b9cf-fad0-f424-e053-dadaa90a57ceRx only
23155-502-052020-01-31C16284748780-19d75b9cf-fad0-f424-e053-dadaa90a57ceRx only
23155-502-102020-01-31C16284748780-19d75b9cf-fad0-f424-e053-dadaa90a57ceRx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
23155-502-01Hydroxyzine hydrochloride100 in 1 BOTTLETABLET10022
23155-502-05Hydroxyzine hydrochloride500 in 1 BOTTLETABLET50022
23155-502-10Hydroxyzine hydrochloride1000 in 1 BOTTLETABLET100022
23155-502-18Hydroxyzine hydrochloride48500 in 1 CONTAINERTABLET4850022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-502-01EA - Each23155-5024608e433-1ad3-45cf-ad4c-62ae2e7bac9012015-11-12
23155-502-05EA - Each23155-502385d633b-4ece-4427-aed9-43c26be6489b12015-11-12
23155-502-10EA - Each23155-502f70742ef-6775-490a-9c51-0522db997b5f12015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROXYZINE HYDROCHLORIDEACTIVE INGREDIENT76755771U3HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
HYDROXYZINEACTIVE MOIETY30S50YM8OGHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
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
23155-502HYDROXYZINE 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
995258hydrOXYzine HCl 25 MG Oral TabletPSN9714d429-e7f6-4adf-b3f0-cb21e6edb4331017
995281hydrOXYzine HCl 50 MG Oral TabletPSN9714d429-e7f6-4adf-b3f0-cb21e6edb4331017
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD9714d429-e7f6-4adf-b3f0-cb21e6edb4331017
995281hydroxyzine hydrochloride 50 MG Oral TabletSCD9714d429-e7f6-4adf-b3f0-cb21e6edb4331017
995281hydrOXYzine HCl 50 MG Oral TabletPSN1350964e-663e-4a50-8c4c-cda371a694a026
995281hydroxyzine hydrochloride 50 MG Oral TabletSCD1350964e-663e-4a50-8c4c-cda371a694a026
995281hydrOXYzine HCl 50 MG Oral TabletPSNca015a35-1f94-4f92-9143-3f149982d31625
995281hydroxyzine hydrochloride 50 MG Oral TabletSCDca015a35-1f94-4f92-9143-3f149982d31625
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
995281hydrOXYzine HCl 50 MG Oral TabletPSN44c63e67-a9e0-4a4f-b34e-2ca60a98176623
995281hydroxyzine hydrochloride 50 MG Oral TabletSCD44c63e67-a9e0-4a4f-b34e-2ca60a98176623
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
995281hydrOXYzine HCl 50 MG Oral TabletPSN4c2c4d8e-c3d1-48c7-8f99-ffa15966746514
995281hydroxyzine hydrochloride 50 MG Oral TabletSCD4c2c4d8e-c3d1-48c7-8f99-ffa15966746514
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 TabletPSN73993c7e-acd7-4835-be03-f8274a15955b4
995281hydrOXYzine HCl 50 MG Oral TabletPSN7f76580c-96a0-4b56-8986-ff5488bb98694
995218hydroxyzine hydrochloride 10 MG Oral TabletSCD7f76580c-96a0-4b56-8986-ff5488bb98694
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD7f76580c-96a0-4b56-8986-ff5488bb98694
995281hydroxyzine hydrochloride 50 MG Oral TabletSCD73993c7e-acd7-4835-be03-f8274a15955b4
995281hydroxyzine hydrochloride 50 MG Oral TabletSCD7f76580c-96a0-4b56-8986-ff5488bb98694
995218hydrOXYzine HCl 10 MG Oral TabletPSN2fc9b08a-e675-dbc5-e063-6294a90ad0542
995258hydrOXYzine HCl 25 MG Oral TabletPSN2fc9b08a-e675-dbc5-e063-6294a90ad0542
995281hydrOXYzine HCl 50 MG Oral TabletPSN2fc9b08a-e675-dbc5-e063-6294a90ad0542
995281hydrOXYzine HCl 50 MG Oral TabletPSNf2b3d10f-2599-5b71-e053-2a95a90a54bb2
995218hydroxyzine hydrochloride 10 MG Oral TabletSCD2fc9b08a-e675-dbc5-e063-6294a90ad0542
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD2fc9b08a-e675-dbc5-e063-6294a90ad0542
995281hydroxyzine hydrochloride 50 MG Oral TabletSCD2fc9b08a-e675-dbc5-e063-6294a90ad0542
995281hydroxyzine hydrochloride 50 MG Oral TabletSCDf2b3d10f-2599-5b71-e053-2a95a90a54bb2
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 TabletPSN953bc2f8-00e6-4a5a-970e-64c048a2559f1
995281hydrOXYzine HCl 50 MG Oral TabletPSN4f3266f4-00a6-4c0c-bff2-e606913de8941
995281hydrOXYzine HCl 50 MG Oral TabletPSN5a92df4e-30b4-b295-e053-2991aa0ab4a91
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 TabletSCD953bc2f8-00e6-4a5a-970e-64c048a2559f1
995281hydroxyzine hydrochloride 50 MG Oral TabletSCD5a92df4e-30b4-b295-e053-2991aa0ab4a91
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
23155-502-0123155050201100 TABLET in 1 BOTTLE (23155-502-01) 100 tablet2014-08-200000-00-00NoNoCurrent
23155-502-0523155050205500 TABLET in 1 BOTTLE (23155-502-05) 500 tablet2014-08-200000-00-00NoNoCurrent
23155-502-10231550502101000 TABLET in 1 BOTTLE (23155-502-10) 1000 tablet2014-08-200000-00-00NoNoCurrent
23155-502-182315505021848500 in 1 CONTAINERHistorical