HYDROXYZINE HYDROCHLORIDE

Product NDC
61919-122
11-digit product format
619190122
Labeler code
61919
Product ID
61919-122_28e47db8-9503-43db-a66f-407e26ebd1df
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROXYZINE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DIRECT RX
Application
ANDA040804
Marketing category
ANDA
Marketing start
2015-01-01
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
61919-122-152020-01-31C16284748780-19d75b9d1-2913-f424-e053-dadaa90a57ceHYDROXYZINE HYDROCHLORIDE
61919-122-202020-01-31C16284748780-19d75b9d1-2913-f424-e053-dadaa90a57ceHYDROXYZINE HYDROCHLORIDE
61919-122-302020-01-31C16284748780-19d75b9d1-2913-f424-e053-dadaa90a57ceHYDROXYZINE HYDROCHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-122-15HYDROXYZINE HYDROCHLORIDE15 in 1 BOTTLETABLET, FILM COATED152
61919-122-20HYDROXYZINE HYDROCHLORIDE20 in 1 BOTTLETABLET, FILM COATED202
61919-122-30HYDROXYZINE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-122-15EA - Each61919-122e35fae82-c801-4155-a620-9732c6b7249712015-03-03
61919-122-20EA - Each61919-12215005939-6b6c-443b-9de0-2a9c9280dcb712015-10-02
61919-122-30EA - Each61919-1224032234c-5526-4939-a007-5b7b817738a112015-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROXYZINE HYDROCHLORIDEACTIVE INGREDIENT76755771U3HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]2
HYDROXYZINEACTIVE MOIETY30S50YM8OGHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-122HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]2Legacy NDC, 3 package rows20150806_02aee05a-2e3b-4a2f-85e7-8cbadd667a85.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995258hydrOXYzine HCl 25 MG Oral TabletPSN02aee05a-2e3b-4a2f-85e7-8cbadd667a852
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD02aee05a-2e3b-4a2f-85e7-8cbadd667a852

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-122-156191901221515 in 1 BOTTLEHistorical
61919-122-206191901222020 in 1 BOTTLEHistorical
61919-122-306191901223030 in 1 BOTTLEHistorical