Hydroxyzine Hydrochloride

Product NDC
67405-577
11-digit product format
674050577
Labeler code
67405
Product ID
67405-577_5aea21fd-0695-44ba-bceb-72ad5b23496f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
HARRIS Pharmaceutical, Inc.
Application
ANDA040808
Marketing category
ANDA
Marketing start
2007-06-29
Marketing end
0000-00-00
Substance
HYDROXYZINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Antihistamine [EPC],Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67405-577-10EA - Each67405-5771f2ea70e-3710-4b89-9f6c-a6c3b76ba31212012-07-24
67405-577-50EA - Each67405-577ee6a4c71-05df-4464-aa06-a81e7b97253612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROXYZINE HYDROCHLORIDEACTIVE INGREDIENT76755771U3HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
HYDROXYZINEACTIVE MOIETY30S50YM8OGHYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKHYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZHYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOHYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEHYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AHYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
TRIACETININACTIVE INGREDIENTXHX3C3X673HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995258hydrOXYzine HCl 25 MG Oral TabletPSN31a005d8-7b61-4cac-bac5-78b0c09d46ca1
995281hydrOXYzine HCl 50 MG Oral TabletPSN31a005d8-7b61-4cac-bac5-78b0c09d46ca1
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD31a005d8-7b61-4cac-bac5-78b0c09d46ca1
995281hydroxyzine hydrochloride 50 MG Oral TabletSCD31a005d8-7b61-4cac-bac5-78b0c09d46ca1