FDA.reportPublic FDA data

Hydroxyzine Hydrochloride

Product NDC
0093-5060
11-digit product format
000935060
Labeler code
0093
Product ID
0093-5060_ce53cc7b-dd6d-4a1b-b64b-ca0b45f67512
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA088617
Marketing category
ANDA
Marketing start
2013-02-19
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0093-5060-01Hydroxyzine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED10017
0093-5060-05Hydroxyzine Hydrochloride500 in 1 BOTTLETABLET, FILM COATED50017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-5060-01EA - Each0093-5060fad114e7-9344-4f78-bc8e-58e7bb69c3bb12013-05-02
0093-5060-05EA - Each0093-50604f5fdba4-7564-426e-9812-8194b545812a12013-03-03
0093-5060-10EA - Each0093-50607e84ac49-24c2-468c-b5b2-4f008ca25d8712013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROXYZINE HYDROCHLORIDEACTIVE INGREDIENT76755771U3HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]6
HYDROXYZINEACTIVE MOIETY30S50YM8OGHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]6
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]6
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]6
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]6
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]6
HYPROMELLOSE 2910 (50 MPA.S)INACTIVE INGREDIENT1IVH67816NHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]6
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]6
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]6
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]6
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]6
TRIACETININACTIVE INGREDIENTXHX3C3X673HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-5060HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.]16Current NDC, Legacy NDC, 2 package rows20220601_80309ec1-e5d5-4454-b8ce-67d7e6805e44.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995218hydrOXYzine HCl 10 MG Oral TabletPSN9c2c05e0-b123-4ddf-8b07-6bb3ca0678b5103
995218hydroxyzine hydrochloride 10 MG Oral TabletSCD9c2c05e0-b123-4ddf-8b07-6bb3ca0678b5103
995218hydrOXYzine HCl 10 MG Oral TabletPSN7165a30c-09e4-4ca1-8548-bf71998ba12f20
995218hydroxyzine hydrochloride 10 MG Oral TabletSCD7165a30c-09e4-4ca1-8548-bf71998ba12f20
995218hydrOXYzine HCl 10 MG Oral TabletPSN80309ec1-e5d5-4454-b8ce-67d7e6805e4417
995258hydrOXYzine HCl 25 MG Oral TabletPSN80309ec1-e5d5-4454-b8ce-67d7e6805e4417
995281hydrOXYzine HCl 50 MG Oral TabletPSN80309ec1-e5d5-4454-b8ce-67d7e6805e4417
995218hydroxyzine hydrochloride 10 MG Oral TabletSCD80309ec1-e5d5-4454-b8ce-67d7e6805e4417
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD80309ec1-e5d5-4454-b8ce-67d7e6805e4417
995281hydroxyzine hydrochloride 50 MG Oral TabletSCD80309ec1-e5d5-4454-b8ce-67d7e6805e4417
995218hydrOXYzine HCl 10 MG Oral TabletPSN93d117dd-e2bf-4daa-abe3-d4fefed3313c14
995258hydrOXYzine HCl 25 MG Oral TabletPSN93d117dd-e2bf-4daa-abe3-d4fefed3313c14
995281hydrOXYzine HCl 50 MG Oral TabletPSN93d117dd-e2bf-4daa-abe3-d4fefed3313c14
995218hydroxyzine hydrochloride 10 MG Oral TabletSCD93d117dd-e2bf-4daa-abe3-d4fefed3313c14
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD93d117dd-e2bf-4daa-abe3-d4fefed3313c14
995281hydroxyzine hydrochloride 50 MG Oral TabletSCD93d117dd-e2bf-4daa-abe3-d4fefed3313c14
995218hydrOXYzine HCl 10 MG Oral TabletPSN3946db7c-dc2d-4329-b9ac-f003d8c6d3e113
995218hydroxyzine hydrochloride 10 MG Oral TabletSCD3946db7c-dc2d-4329-b9ac-f003d8c6d3e113
995218hydrOXYzine HCl 10 MG Oral TabletPSN714a26a1-371f-ef23-e053-2a95a90a6af65
995218hydroxyzine hydrochloride 10 MG Oral TabletSCD714a26a1-371f-ef23-e053-2a95a90a6af65
995218hydrOXYzine HCl 10 MG Oral TabletPSN9ef6a4b7-362d-61b4-e053-2995a90a0ebb3
995218hydrOXYzine HCl 10 MG Oral TabletPSN87c4c82c-ae44-769e-e053-2995a90ab6ff3
995218hydroxyzine hydrochloride 10 MG Oral TabletSCD87c4c82c-ae44-769e-e053-2995a90ab6ff3
995218hydroxyzine hydrochloride 10 MG Oral TabletSCD9ef6a4b7-362d-61b4-e053-2995a90a0ebb3
995218hydrOXYzine HCl 10 MG Oral TabletPSN47bda4fe-ddb7-4140-900a-970373cc7acc2
995258hydrOXYzine HCl 25 MG Oral TabletPSN47bda4fe-ddb7-4140-900a-970373cc7acc2
995281hydrOXYzine HCl 50 MG Oral TabletPSN47bda4fe-ddb7-4140-900a-970373cc7acc2
995218hydroxyzine hydrochloride 10 MG Oral TabletSCD47bda4fe-ddb7-4140-900a-970373cc7acc2
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD47bda4fe-ddb7-4140-900a-970373cc7acc2
995281hydroxyzine hydrochloride 50 MG Oral TabletSCD47bda4fe-ddb7-4140-900a-970373cc7acc2
995218hydrOXYzine HCl 10 MG Oral TabletPSN26ba9461-aa4b-9d09-e063-6394a90a29ae1
995218hydroxyzine hydrochloride 10 MG Oral TabletSCD26ba9461-aa4b-9d09-e063-6394a90a29ae1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0093-5060-0100093506001100 TABLET, FILM COATED in 1 BOTTLE (0093-5060-01) 2013-04-080000-00-00NoNoCurrent
0093-5060-0500093506005500 TABLET, FILM COATED in 1 BOTTLE (0093-5060-05) 2013-02-210000-00-00NoNoCurrent