FDA.reportPublic FDA data

Hydroxyzine Hydrochloride

Product NDC
52959-074
11-digit product format
529590074
Labeler code
52959
Product ID
52959-074_104d12ea-e22c-46e6-b3c6-7bb45c4c01c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA040804
Marketing category
ANDA
Marketing start
2008-06-30
Marketing end
0000-00-00
Substance
HYDROXYZINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Antihistamine [EPC],Histamine Receptor Antagonists [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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
52959-074-122019-11-13C16284748780-197449f38-bfd2-f6ea-e053-dbdaa90aa703HYDROXYZINE HYDROCHLORIDE TABLETS, USP Rx only
52959-074-132019-11-13C16284748780-197449f38-bfd2-f6ea-e053-dbdaa90aa703HYDROXYZINE HYDROCHLORIDE TABLETS, USP Rx only
52959-074-152019-11-13C16284748780-197449f38-bfd2-f6ea-e053-dbdaa90aa703HYDROXYZINE HYDROCHLORIDE TABLETS, USP Rx only
52959-074-162019-11-13C16284748780-197449f38-bfd2-f6ea-e053-dbdaa90aa703HYDROXYZINE HYDROCHLORIDE TABLETS, USP Rx only
52959-074-202019-11-13C16284748780-197449f38-bfd2-f6ea-e053-dbdaa90aa703HYDROXYZINE HYDROCHLORIDE TABLETS, USP Rx only
52959-074-212019-11-13C16284748780-197449f38-bfd2-f6ea-e053-dbdaa90aa703HYDROXYZINE HYDROCHLORIDE TABLETS, USP Rx only
52959-074-242019-11-13C16284748780-197449f38-bfd2-f6ea-e053-dbdaa90aa703HYDROXYZINE HYDROCHLORIDE TABLETS, USP Rx only
52959-074-302019-11-13C16284748780-197449f38-bfd2-f6ea-e053-dbdaa90aa703HYDROXYZINE HYDROCHLORIDE TABLETS, USP Rx only
52959-074-402019-11-13C16284748780-197449f38-bfd2-f6ea-e053-dbdaa90aa703HYDROXYZINE HYDROCHLORIDE TABLETS, USP Rx only
52959-074-502019-11-13C16284748780-197449f38-bfd2-f6ea-e053-dbdaa90aa703HYDROXYZINE HYDROCHLORIDE TABLETS, USP Rx only
52959-074-602019-11-13C16284748780-197449f38-bfd2-f6ea-e053-dbdaa90aa703HYDROXYZINE HYDROCHLORIDE TABLETS, USP Rx only
52959-074-902019-11-13C16284748780-197449f38-bfd2-f6ea-e053-dbdaa90aa703HYDROXYZINE HYDROCHLORIDE TABLETS, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-074-12Hydroxyzine Hydrochloride12 in 1 BOTTLETABLET, FILM COATED123
52959-074-13Hydroxyzine Hydrochloride13 in 1 BOTTLETABLET, FILM COATED133
52959-074-15Hydroxyzine Hydrochloride15 in 1 BOTTLETABLET, FILM COATED153
52959-074-16Hydroxyzine Hydrochloride16 in 1 BOTTLETABLET, FILM COATED163
52959-074-20Hydroxyzine Hydrochloride20 in 1 BOTTLETABLET, FILM COATED203
52959-074-21Hydroxyzine Hydrochloride21 in 1 BOTTLETABLET, FILM COATED213
52959-074-24Hydroxyzine Hydrochloride24 in 1 BOTTLETABLET, FILM COATED243
52959-074-30Hydroxyzine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED303
52959-074-40Hydroxyzine Hydrochloride40 in 1 BOTTLETABLET, FILM COATED403
52959-074-50Hydroxyzine Hydrochloride50 in 1 BOTTLETABLET, FILM COATED503
52959-074-60Hydroxyzine Hydrochloride60 in 1 BOTTLETABLET, FILM COATED603
52959-074-90Hydroxyzine Hydrochloride90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-074-12EA - Each52959-074dddba10c-d204-4d8b-9002-dbfa09855ae112012-07-24
52959-074-13EA - Each52959-074a819dd38-c743-4b0b-90b4-43be68d7cca612012-07-24
52959-074-15EA - Each52959-07444d58544-9e4d-4b38-9d06-a6f5e6bba13812012-07-24
52959-074-16EA - Each52959-074b1b6d3c5-d947-4fe0-8f6b-a70f1639ffbc12012-07-24
52959-074-20EA - Each52959-074748c9506-db93-4e93-b1b4-e1e7b5e2f97512012-07-24
52959-074-21EA - Each52959-074249bf321-7408-4bf1-8563-986e6c6ffe7f12012-07-24
52959-074-24EA - Each52959-0740607f27a-30a2-40a6-b222-8f222181b12212012-07-24
52959-074-30EA - Each52959-074d9bcada1-6368-4945-8ea3-981905beef2412012-07-24
52959-074-40EA - Each52959-074294de092-70bd-4689-bb36-7653fd6789ef12012-07-24
52959-074-50EA - Each52959-074d8f823db-6b05-4f21-826c-af9e98f8a09312012-07-24
52959-074-60EA - Each52959-074c1efe537-e692-4a91-8219-de3648f447ad12012-07-24
52959-074-90EA - Each52959-07413d99832-981e-4c4b-8bba-06ab1b2a846f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROXYZINE HYDROCHLORIDEACTIVE INGREDIENT76755771U3HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]3
HYDROXYZINEACTIVE MOIETY30S50YM8OGHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]3
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-074HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]3Legacy NDC, 12 package rows20120124_80833d7f-8a36-470a-b7ba-6343549e2273.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995258hydrOXYzine HCl 25 MG Oral TabletPSN80833d7f-8a36-470a-b7ba-6343549e22733
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD80833d7f-8a36-470a-b7ba-6343549e22733

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-074-125295900741212 in 1 BOTTLEHistorical
52959-074-135295900741313 in 1 BOTTLEHistorical
52959-074-155295900741515 in 1 BOTTLEHistorical
52959-074-165295900741616 in 1 BOTTLEHistorical
52959-074-205295900742020 in 1 BOTTLEHistorical
52959-074-215295900742121 in 1 BOTTLEHistorical
52959-074-245295900742424 in 1 BOTTLEHistorical
52959-074-305295900743030 in 1 BOTTLEHistorical
52959-074-405295900744040 in 1 BOTTLEHistorical
52959-074-505295900745050 in 1 BOTTLEHistorical
52959-074-605295900746060 in 1 BOTTLEHistorical
52959-074-905295900749090 in 1 BOTTLEHistorical