FDA.reportPublic FDA data

Hydroxyzine hydrochloride

Product NDC
63629-4929
11-digit product format
636294929
Labeler code
63629
Product ID
63629-4929_9efda664-6143-4427-9290-60c6abf0ec0b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA204279
Marketing category
ANDA
Marketing start
2014-08-20
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
Rxcui995258, 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
63629-4929-1Hydroxyzine hydrochloride120 in 1 BOTTLETABLET, FILM COATED1201017
63629-4929-2Hydroxyzine hydrochloride20 in 1 BOTTLETABLET, FILM COATED201017
63629-4929-3Hydroxyzine hydrochloride30 in 1 BOTTLETABLET, FILM COATED301017
63629-4929-4Hydroxyzine hydrochloride60 in 1 BOTTLETABLET, FILM COATED601017
63629-4929-5Hydroxyzine hydrochloride90 in 1 BOTTLETABLET, FILM COATED901017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-4929-1EA - Each63629-4929da357069-58d8-4902-b192-cd88fd6b55cb12017-03-06
63629-4929-2EA - Each63629-492983403579-a54f-4cf1-ae13-20c1d82ad96012017-03-06
63629-4929-3EA - Each63629-4929f3c08d6e-f07c-4d83-a999-d6b30522129412017-03-06
63629-4929-4EA - Each63629-4929a907294e-4835-4e7f-bdaf-a072839a61f112017-03-06
63629-4929-5EA - Each63629-4929e9016956-ac4f-46c8-934a-3416a08a001f12017-03-06

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-4929HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1017Current NDC, Legacy NDC, 5 package rows20240824_9714d429-e7f6-4adf-b3f0-cb21e6edb433.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-4929-163629492901120 TABLET, FILM COATED in 1 BOTTLE (63629-4929-1) 2014-08-200000-00-00NoNoCurrent
63629-4929-26362949290220 TABLET, FILM COATED in 1 BOTTLE (63629-4929-2) 2014-08-200000-00-00NoNoCurrent
63629-4929-36362949290330 TABLET, FILM COATED in 1 BOTTLE (63629-4929-3) 2014-08-200000-00-00NoNoCurrent
63629-4929-46362949290460 TABLET, FILM COATED in 1 BOTTLE (63629-4929-4) 2014-08-200000-00-00NoNoCurrent
63629-4929-56362949290590 TABLET, FILM COATED in 1 BOTTLE (63629-4929-5) 2014-08-200000-00-00NoNoCurrent