FDA.reportPublic FDA data

Hydroxyzine Hydrochloride

Product NDC
0093-5061
11-digit product format
000935061
Labeler code
0093
Product ID
0093-5061_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
ANDA088618
Marketing category
ANDA
Marketing start
2012-10-09
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0093-5061-01Hydroxyzine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED10017
0093-5061-05Hydroxyzine Hydrochloride500 in 1 BOTTLETABLET, FILM COATED50017
0093-5061-10Hydroxyzine Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED100017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-5061-01EA - Each0093-50615dbcfb0d-a5d1-41ee-b089-58a572c3034212013-02-13
0093-5061-05EA - Each0093-5061a12c332e-49bb-4f46-b113-d08e26f2da7712013-02-13
0093-5061-10EA - Each0093-5061669a0c2a-4b46-4bbe-8d12-b68525163e4e12013-02-13

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
0093-5061HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.]16Current NDC, Legacy NDC, 3 package rows20220601_80309ec1-e5d5-4454-b8ce-67d7e6805e44.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995258hydrOXYzine HCl 25 MG Oral TabletPSN3f90259a-a684-498f-8963-d02eaba2e9db103
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD3f90259a-a684-498f-8963-d02eaba2e9db103
995258hydrOXYzine HCl 25 MG Oral TabletPSN2b05bd0e-af57-4e74-92f8-a4311330142f23
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD2b05bd0e-af57-4e74-92f8-a4311330142f23
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
995258hydrOXYzine HCl 25 MG Oral TabletPSNca67c061-c743-4ebb-a9d5-ece48806066316
995258hydroxyzine hydrochloride 25 MG Oral TabletSCDca67c061-c743-4ebb-a9d5-ece48806066316
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
995258hydrOXYzine HCl 25 MG Oral TabletPSN5cc3aaa6-e18f-a116-e053-2991aa0a142210
995258hydrOXYzine HCl 25 MG Oral TabletPSN6ad55cd1-a284-4c3d-aa90-653704afdb7510
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD5cc3aaa6-e18f-a116-e053-2991aa0a142210
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD6ad55cd1-a284-4c3d-aa90-653704afdb7510
995258hydrOXYzine HCl 25 MG Oral TabletPSNd79be126-39cd-4dbb-ad88-0e4c18109dda7
995258hydroxyzine hydrochloride 25 MG Oral TabletSCDd79be126-39cd-4dbb-ad88-0e4c18109dda7
995258hydrOXYzine HCl 25 MG Oral TabletPSN8ae73c6f-7134-42f0-a1ad-5dfafedf5c085
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD8ae73c6f-7134-42f0-a1ad-5dfafedf5c085
995258hydrOXYzine HCl 25 MG Oral TabletPSNdb0dce55-5984-7580-e053-2a95a90a36954
995258hydroxyzine hydrochloride 25 MG Oral TabletSCDdb0dce55-5984-7580-e053-2a95a90a36954
995258hydrOXYzine HCl 25 MG Oral TabletPSN737cf5a4-cf8f-5044-e053-2a91aa0aac4b3
995258hydrOXYzine HCl 25 MG Oral TabletPSNd307dc62-a7fb-4013-8f3c-28280e2d650b3
995258hydrOXYzine HCl 25 MG Oral TabletPSN4f1c614f-8535-401e-af27-8850ba3d6d603
995258hydroxyzine hydrochloride 25 MG Oral TabletSCDd307dc62-a7fb-4013-8f3c-28280e2d650b3
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD4f1c614f-8535-401e-af27-8850ba3d6d603
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD737cf5a4-cf8f-5044-e053-2a91aa0aac4b3
995218hydrOXYzine HCl 10 MG Oral TabletPSN47bda4fe-ddb7-4140-900a-970373cc7acc2
995258hydrOXYzine HCl 25 MG Oral TabletPSN96399093-415c-274b-e053-2a95a90a24b22
995258hydrOXYzine HCl 25 MG Oral TabletPSN47bda4fe-ddb7-4140-900a-970373cc7acc2
995258hydrOXYzine HCl 25 MG Oral TabletPSN963e8380-8a29-4440-b946-6238011cc7762
995258hydrOXYzine HCl 25 MG Oral TabletPSN9002e925-463c-0cbc-e053-2995a90ac2a32
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 TabletSCD96399093-415c-274b-e053-2a95a90a24b22
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD963e8380-8a29-4440-b946-6238011cc7762
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD47bda4fe-ddb7-4140-900a-970373cc7acc2
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD9002e925-463c-0cbc-e053-2995a90ac2a32
995281hydroxyzine hydrochloride 50 MG Oral TabletSCD47bda4fe-ddb7-4140-900a-970373cc7acc2
995258hydrOXYzine HCl 25 MG Oral TabletPSN1767a886-ec92-39fb-e063-6294a90a12491
995258hydrOXYzine HCl 25 MG Oral TabletPSN0dfe1d68-ba49-4435-8a51-33af47580c451
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD1767a886-ec92-39fb-e063-6294a90a12491
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD0dfe1d68-ba49-4435-8a51-33af47580c451

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0093-5061-0100093506101100 TABLET, FILM COATED in 1 BOTTLE (0093-5061-01) 2012-10-090000-00-00NoNoCurrent
0093-5061-0500093506105500 TABLET, FILM COATED in 1 BOTTLE (0093-5061-05) 2012-10-100000-00-00NoNoCurrent
0093-5061-10000935061101000 TABLET, FILM COATED in 1 BOTTLE (0093-5061-10) 2012-10-110000-00-00NoNoCurrent