FDA.reportPublic FDA data

Hydroxyzine Hydrochloride

Product NDC
31722-500
11-digit product format
317220500
Labeler code
31722
Product ID
31722-500_ee32d5bd-38fb-4a93-e053-2a95a90a0464
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA040805
Marketing category
ANDA
Marketing start
2008-05-29
Substance
HYDROXYZINE DIHYDROCHLORIDE
Active strength
10 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 DIHYDROCHLORIDE10 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
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
31722-500-01Hydroxyzine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1006
31722-500-05Hydroxyzine Hydrochloride500 in 1 BOTTLETABLET, FILM COATED5006
31722-500-10Hydroxyzine Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED10006

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROXYZINE HYDROCHLORIDEACTIVE INGREDIENT76755771U3HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1
HYDROXYZINEACTIVE MOIETY30S50YM8OGHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-500HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 3 package rows20221125_f7e527fe-2f67-45ad-a3ec-146ead819514.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995218hydrOXYzine HCl 10 MG Oral TabletPSNf7e527fe-2f67-45ad-a3ec-146ead8195146
995258hydrOXYzine HCl 25 MG Oral TabletPSNf7e527fe-2f67-45ad-a3ec-146ead8195146
995281hydrOXYzine HCl 50 MG Oral TabletPSNf7e527fe-2f67-45ad-a3ec-146ead8195146
995218hydroxyzine hydrochloride 10 MG Oral TabletSCDf7e527fe-2f67-45ad-a3ec-146ead8195146
995258hydroxyzine hydrochloride 25 MG Oral TabletSCDf7e527fe-2f67-45ad-a3ec-146ead8195146
995281hydroxyzine hydrochloride 50 MG Oral TabletSCDf7e527fe-2f67-45ad-a3ec-146ead8195146

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
31722-500-0131722050001100 TABLET, FILM COATED in 1 BOTTLE (31722-500-01) 2008-05-290000-00-00NoNoCurrent
31722-500-0531722050005500 TABLET, FILM COATED in 1 BOTTLE (31722-500-05) 2008-05-290000-00-00NoNoCurrent
31722-500-10317220500101000 TABLET, FILM COATED in 1 BOTTLE (31722-500-10) 2008-05-290000-00-00NoNoCurrent