FDA.reportPublic FDA data

Hydroxyzine Hydrochloride

Product NDC
59651-499
11-digit product format
596510499
Labeler code
59651
Product ID
59651-499_86a715f8-fbfb-4d28-a144-27581d6aa1bb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA087871
Marketing category
ANDA
Marketing start
2021-10-07
Substance
HYDROXYZINE DIHYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hydroxyzine Hydrochloride
Listing expiration
2027-12-31

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
59651-499-01Hydroxyzine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1002
59651-499-05Hydroxyzine Hydrochloride500 in 1 BOTTLETABLET, FILM COATED5002
59651-499-78Hydroxyzine Hydrochloride10 in 1 BLISTER PACKTABLET, FILM COATED102
59651-499-78Hydroxyzine Hydrochloride10 in 1 CARTONTABLET, FILM COATED102
59651-499-99Hydroxyzine Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-499-01EA - Each59651-49968542cd8-432d-411a-8e3b-b192b1bab77112023-09-05
59651-499-05EA - Each59651-499d1691c95-146f-4bfe-8461-8e01210131e912023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-499HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]1Current NDC, Legacy NDC, 5 package rows20220811_9de2de56-614f-4294-8794-d30758cf5f70.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995218hydrOXYzine HCl 10 MG Oral TabletPSN7c959515-a5a9-4d5e-90e9-bd58bc947330100
995218hydrOXYzine HCl 10 MG Oral TabletPSN9504897e-febc-4293-a2dc-9f79f55ea821100
995218hydroxyzine hydrochloride 10 MG Oral TabletSCD7c959515-a5a9-4d5e-90e9-bd58bc947330100
995218hydroxyzine hydrochloride 10 MG Oral TabletSCD9504897e-febc-4293-a2dc-9f79f55ea821100
995218hydrOXYzine HCl 10 MG Oral TabletPSN9de2de56-614f-4294-8794-d30758cf5f702
995258hydrOXYzine HCl 25 MG Oral TabletPSN9de2de56-614f-4294-8794-d30758cf5f702
995281hydrOXYzine HCl 50 MG Oral TabletPSN9de2de56-614f-4294-8794-d30758cf5f702
995218hydroxyzine hydrochloride 10 MG Oral TabletSCD9de2de56-614f-4294-8794-d30758cf5f702
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD9de2de56-614f-4294-8794-d30758cf5f702
995281hydroxyzine hydrochloride 50 MG Oral TabletSCD9de2de56-614f-4294-8794-d30758cf5f702
995218hydrOXYzine HCl 10 MG Oral TabletPSN56b49e5c-bb8a-46cd-873c-3c743d1653a41
995218hydroxyzine hydrochloride 10 MG Oral TabletSCD56b49e5c-bb8a-46cd-873c-3c743d1653a41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59651-499-0159651049901100 TABLET, FILM COATED in 1 BOTTLE (59651-499-01) 2021-10-070000-00-00NoNoCurrent
59651-499-0559651049905500 TABLET, FILM COATED in 1 BOTTLE (59651-499-05) 2021-10-070000-00-00NoNoCurrent
59651-499-785965104997810 BLISTER PACK in 1 CARTON (59651-499-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2021-10-070000-00-00NoNoCurrent
59651-499-99596510499991000 TABLET, FILM COATED in 1 BOTTLE (59651-499-99) 2021-10-070000-00-00NoNoCurrent