HydrOXYzine Hydrochloride

Product NDC
63739-486
11-digit product format
637390486
Labeler code
63739
Product ID
63739-486_ef689679-6686-19a7-e053-2a95a90a3918
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HydrOXYzine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
McKesson Corporation dba SKY Packaging
Application
ANDA040840
Marketing category
ANDA
Marketing start
2009-11-11
Marketing end
0000-00-00
Substance
HYDROXYZINE DIHYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63739-486-102020-07-22C16284748780-1ab0e2407-2d0f-f274-e053-dbdaa90a64717fff369e-efd8-45c7-bc2b-ca8b623fe716

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63739-486-10EA - Each63739-4868f9389eb-1ff9-452a-8668-064de2fd343812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HydrOXYzine HydrochlorideACTIVE INGREDIENT76755771U3HYDROXYZINE HYDROCHLORIDE TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]3
hydrOXYzineACTIVE MOIETY30S50YM8OGHYDROXYZINE HYDROCHLORIDE TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKHYDROXYZINE HYDROCHLORIDE TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROXYZINE HYDROCHLORIDE TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYDROXYZINE HYDROCHLORIDE TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOHYDROXYZINE HYDROCHLORIDE TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROXYZINE HYDROCHLORIDE TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]3
POLYETHYLENE GLYCOL 1000INACTIVE INGREDIENTU076Q6Q621HYDROXYZINE HYDROCHLORIDE TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HHYDROXYZINE HYDROCHLORIDE TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROXYZINE HYDROCHLORIDE TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HYDROXYZINE HYDROCHLORIDE TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROXYZINE HYDROCHLORIDE TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROXYZINE HYDROCHLORIDE TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63739-486HYDROXYZINE HYDROCHLORIDE TABLET [MCKESSON CORPORATION DBA SKY PACKAGING]14Legacy NDC20241228_7fff369e-efd8-45c7-bc2b-ca8b623fe716.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63739-486-106373904861010 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-486-10) > 10 TABLET in 1 BLISTER PACK10 blister pack2011-03-030000-00-00NoNoCurrent