Hydroxyzine Hydrochloride

Product NDC
10702-012
11-digit product format
107020012
Labeler code
10702
Product ID
10702-012_eff46bea-a884-5878-e053-2a95a90ae664
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
KVK-Tech, Inc.
Application
ANDA040786
Marketing category
ANDA
Marketing start
2012-07-24
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
aa1826f4-97c1-4705-bdf0-3bc7d234e618Product name220190618
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
75cb12ee-8eb2-4f1a-a332-5743a5d0da41Product name120151110
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
3ca5f78b-43dc-30fe-8014-55b922af52b3Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10702-012-01Hydroxyzine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED10012
10702-012-10Hydroxyzine Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED100012
10702-012-50Hydroxyzine Hydrochloride500 in 1 BOTTLETABLET, FILM COATED50012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10702-012-01EA - Each10702-0122e6915c4-c522-4e44-9633-216e5750fce512013-02-13
10702-012-10EA - Each10702-01260b56b64-33f0-4e8b-bdc7-7ccf1cf0e78b12013-02-13
10702-012-50EA - Each10702-012483bb061-1dee-4f0b-ba07-8487aa2929fc12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROXYZINE HYDROCHLORIDEACTIVE INGREDIENT76755771U3HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.]2
HYDROXYZINE HYDROCHLORIDEACTIVE INGREDIENT76755771U3HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]2
HYDROXYZINEACTIVE MOIETY30S50YM8OGHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.]2
HYDROXYZINEACTIVE MOIETY30S50YM8OGHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.]2
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]2
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.]2
HYDROXYZINE HYDROCHLORIDEACTIVE INGREDIENT76755771U3HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYDROXYZINE HYDROCHLORIDEACTIVE INGREDIENT76755771U3HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
HYDROXYZINE HYDROCHLORIDEACTIVE INGREDIENT76755771U3HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYDROXYZINEACTIVE MOIETY30S50YM8OGHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYDROXYZINEACTIVE MOIETY30S50YM8OGHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYDROXYZINEACTIVE MOIETY30S50YM8OGHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TALCINACTIVE INGREDIENT7SEV7J4R1UHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TALCINACTIVE INGREDIENT7SEV7J4R1UHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
WATERINACTIVE INGREDIENT059QF0KO0RHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10702-012HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.]12Current NDC, Legacy NDC, 3 package rows20230126_adc4cb73-77c6-48ff-aaf2-b3568d53de1f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995218hydrOXYzine HCl 10 MG Oral TabletPSN1a3e389f-391d-4f37-9e34-ce3c6f5fe8c122
995258hydrOXYzine HCl 25 MG Oral TabletPSN1a3e389f-391d-4f37-9e34-ce3c6f5fe8c122
995281hydrOXYzine HCl 50 MG Oral TabletPSN1a3e389f-391d-4f37-9e34-ce3c6f5fe8c122
995218hydroxyzine hydrochloride 10 MG Oral TabletSCD1a3e389f-391d-4f37-9e34-ce3c6f5fe8c122
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD1a3e389f-391d-4f37-9e34-ce3c6f5fe8c122
995281hydroxyzine hydrochloride 50 MG Oral TabletSCD1a3e389f-391d-4f37-9e34-ce3c6f5fe8c122
995281hydrOXYzine HCl 50 MG Oral TabletPSN263d3f22-a105-4abb-8152-be2081eefcde21
995281hydroxyzine hydrochloride 50 MG Oral TabletSCD263d3f22-a105-4abb-8152-be2081eefcde21
995218hydrOXYzine HCl 10 MG Oral TabletPSNadc4cb73-77c6-48ff-aaf2-b3568d53de1f12
995258hydrOXYzine HCl 25 MG Oral TabletPSNadc4cb73-77c6-48ff-aaf2-b3568d53de1f12
995281hydrOXYzine HCl 50 MG Oral TabletPSNadc4cb73-77c6-48ff-aaf2-b3568d53de1f12
995218hydroxyzine hydrochloride 10 MG Oral TabletSCDadc4cb73-77c6-48ff-aaf2-b3568d53de1f12
995258hydroxyzine hydrochloride 25 MG Oral TabletSCDadc4cb73-77c6-48ff-aaf2-b3568d53de1f12
995281hydroxyzine hydrochloride 50 MG Oral TabletSCDadc4cb73-77c6-48ff-aaf2-b3568d53de1f12
995281hydrOXYzine HCl 50 MG Oral TabletPSNa24f665c-dc77-4911-81d0-2608d955f4781
995281hydrOXYzine HCl 50 MG Oral TabletPSNa68e3f08-4bb6-496d-9b3b-b0d4aface8091
995281hydrOXYzine HCl 50 MG Oral TabletPSN98bde88d-2741-490e-8b00-14b7eec6d8531
995281hydroxyzine hydrochloride 50 MG Oral TabletSCD98bde88d-2741-490e-8b00-14b7eec6d8531
995281hydroxyzine hydrochloride 50 MG Oral TabletSCDa24f665c-dc77-4911-81d0-2608d955f4781
995281hydroxyzine hydrochloride 50 MG Oral TabletSCDa68e3f08-4bb6-496d-9b3b-b0d4aface8091

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
10702-012-0110702001201100 TABLET, FILM COATED in 1 BOTTLE (10702-012-01) 2012-07-240000-00-00NoNoCurrent
10702-012-10107020012101000 TABLET, FILM COATED in 1 BOTTLE (10702-012-10) 2012-07-240000-00-00NoNoCurrent
10702-012-5010702001250500 TABLET, FILM COATED in 1 BOTTLE (10702-012-50) 2012-07-240000-00-00NoNoCurrent