FDA.reportPublic FDA data

Hydroxyzine hydrochloride

Product NDC
23155-501
11-digit product format
231550501
Labeler code
23155
Product ID
23155-501_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
25 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 DIHYDROCHLORIDE25 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
23155-501-012020-03-26C16284748780-19d75b9cf-fad0-f424-e053-dadaa90a57ceRx only
23155-501-052020-03-26C16284748780-19d75b9cf-fad0-f424-e053-dadaa90a57ceRx only
23155-501-102020-03-26C16284748780-19d75b9cf-fad0-f424-e053-dadaa90a57ceRx only
23155-501-012020-01-31C16284748780-19d75b9cf-fad0-f424-e053-dadaa90a57ceRx only
23155-501-052020-01-31C16284748780-19d75b9cf-fad0-f424-e053-dadaa90a57ceRx only
23155-501-102020-01-31C16284748780-19d75b9cf-fad0-f424-e053-dadaa90a57ceRx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
23155-501-01Hydroxyzine hydrochloride100 in 1 BOTTLETABLET10022
23155-501-05Hydroxyzine hydrochloride500 in 1 BOTTLETABLET50022
23155-501-10Hydroxyzine hydrochloride1000 in 1 BOTTLETABLET100022
23155-501-18Hydroxyzine hydrochloride97000 in 1 CONTAINERTABLET9700022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-501-01EA - Each23155-5014739b064-ed04-46fc-8e9d-61484164952c12015-11-12
23155-501-05EA - Each23155-5019fe7ebc6-664c-4a24-8963-f00f3519adc712015-11-12
23155-501-10EA - Each23155-50180446344-400b-4d2c-8e8a-1cc7bc387dd312015-11-12

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
23155-501HYDROXYZINE 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
995258hydrOXYzine HCl 25 MG Oral TabletPSNe4c60e14-28c7-46e2-9fdc-b1a1ce54f3c2102
995258hydroxyzine hydrochloride 25 MG Oral TabletSCDe4c60e14-28c7-46e2-9fdc-b1a1ce54f3c2102
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
995258hydrOXYzine HCl 25 MG Oral TabletPSN2e346b0c-9407-4346-82c2-d9755cbcd8b025
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD2e346b0c-9407-4346-82c2-d9755cbcd8b025
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
995258hydrOXYzine HCl 25 MG Oral TabletPSNb6189074-e199-4f58-a78d-c04f131c13d913
995258hydroxyzine hydrochloride 25 MG Oral TabletSCDb6189074-e199-4f58-a78d-c04f131c13d913
995258hydrOXYzine HCl 25 MG Oral TabletPSN5cc3aaa6-e18f-a116-e053-2991aa0a142210
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD5cc3aaa6-e18f-a116-e053-2991aa0a142210
995258hydrOXYzine HCl 25 MG Oral TabletPSN80e60583-76d3-4e65-8581-4cdaff7cd1c19
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD80e60583-76d3-4e65-8581-4cdaff7cd1c19
995258hydrOXYzine HCl 25 MG Oral TabletPSN57e9cb6c-4718-7821-e053-2991aa0afa6b6
995258hydrOXYzine HCl 25 MG Oral TabletPSN83e8d60d-36fd-4223-b50c-e6615045352a6
995258hydrOXYzine HCl 25 MG Oral TabletPSN63fdf791-1a58-45ba-8ef2-15b80bb24f236
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD83e8d60d-36fd-4223-b50c-e6615045352a6
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD57e9cb6c-4718-7821-e053-2991aa0afa6b6
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD63fdf791-1a58-45ba-8ef2-15b80bb24f236
995258hydrOXYzine HCl 25 MG Oral TabletPSNc13455a3-3078-4fe1-e053-2a95a90adf8e5
995258hydroxyzine hydrochloride 25 MG Oral TabletSCDc13455a3-3078-4fe1-e053-2a95a90adf8e5
995218hydrOXYzine HCl 10 MG Oral TabletPSN7f76580c-96a0-4b56-8986-ff5488bb98694
995258hydrOXYzine HCl 25 MG Oral TabletPSN92d8cc57-7e3a-4217-9160-e1b56db5570e4
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
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD92d8cc57-7e3a-4217-9160-e1b56db5570e4
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD7f76580c-96a0-4b56-8986-ff5488bb98694
995281hydroxyzine hydrochloride 50 MG Oral TabletSCD7f76580c-96a0-4b56-8986-ff5488bb98694
995258hydrOXYzine HCl 25 MG Oral TabletPSN75d77013-ddea-a712-e053-2a91aa0ada6f3
995258hydrOXYzine HCl 25 MG Oral TabletPSNa8af7dd0-fef8-5c39-e053-2a95a90ae11a3
995258hydroxyzine hydrochloride 25 MG Oral TabletSCDa8af7dd0-fef8-5c39-e053-2a95a90ae11a3
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD75d77013-ddea-a712-e053-2a91aa0ada6f3
995218hydrOXYzine HCl 10 MG Oral TabletPSN2fc9b08a-e675-dbc5-e063-6294a90ad0542
995258hydrOXYzine HCl 25 MG Oral TabletPSN09092888-0c18-501d-e063-6294a90aad672
995258hydrOXYzine HCl 25 MG Oral TabletPSN4f32ed01-7470-4909-afe4-7831a5bd90bb2
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
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD09092888-0c18-501d-e063-6294a90aad672
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD4f32ed01-7470-4909-afe4-7831a5bd90bb2
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 TabletPSN4f3266f4-00a6-4c0c-bff2-e606913de8941
995258hydrOXYzine HCl 25 MG Oral TabletPSN4f3266f4-00a6-4c0c-bff2-e606913de8941
995258hydrOXYzine HCl 25 MG Oral TabletPSN13172e1e-2b62-8a67-e063-6394a90a30101
995258hydrOXYzine HCl 25 MG Oral TabletPSN26ba1041-8a86-53a9-e063-6394a90aa2fe1
995258hydrOXYzine HCl 25 MG Oral TabletPSN3a61627a-7ef8-495a-b798-6774eb38633a1
995258hydrOXYzine HCl 25 MG Oral TabletPSN7b6ebf69-77d5-434f-81a4-3d5587fd431e1
995258hydrOXYzine HCl 25 MG Oral TabletPSNa853a130-26f4-a657-e053-2995a90a26511
995258hydrOXYzine HCl 25 MG Oral TabletPSN508848a5-017c-dd3e-e063-6294a90a456b1
995258hydrOXYzine HCl 25 MG Oral TabletPSN5bd46f87-5e1a-2d23-e053-2a91aa0a89591
995281hydrOXYzine HCl 50 MG Oral TabletPSN4f3266f4-00a6-4c0c-bff2-e606913de8941
995218hydroxyzine hydrochloride 10 MG Oral TabletSCD4f3266f4-00a6-4c0c-bff2-e606913de8941
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD3a61627a-7ef8-495a-b798-6774eb38633a1
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD4f3266f4-00a6-4c0c-bff2-e606913de8941
995258hydroxyzine hydrochloride 25 MG Oral TabletSCDa853a130-26f4-a657-e053-2995a90a26511
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD508848a5-017c-dd3e-e063-6294a90a456b1
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD26ba1041-8a86-53a9-e063-6394a90aa2fe1
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD13172e1e-2b62-8a67-e063-6394a90a30101
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD5bd46f87-5e1a-2d23-e053-2a91aa0a89591
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD7b6ebf69-77d5-434f-81a4-3d5587fd431e1
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
23155-501-0123155050101100 TABLET in 1 BOTTLE (23155-501-01) 100 tablet2014-08-200000-00-00NoNoCurrent
23155-501-0523155050105500 TABLET in 1 BOTTLE (23155-501-05) 500 tablet2014-08-200000-00-00NoNoCurrent
23155-501-10231550501101000 TABLET in 1 BOTTLE (23155-501-10) 1000 tablet2014-08-200000-00-00NoNoCurrent
23155-501-182315505011897000 in 1 CONTAINERHistorical