FDA.reportPublic FDA data

Hydroxyzine Hydrochloride

Product NDC
62135-575
11-digit product format
621350575
Labeler code
62135
Product ID
62135-575_459c9507-ea13-81b1-e063-6394a90a3db4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA204279
Marketing category
ANDA
Marketing start
2014-08-20
Substance
HYDROXYZINE DIHYDROCHLORIDE
Active strength
50 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 DIHYDROCHLORIDE50 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
62135-575-05Hydroxyzine Hydrochloride500 in 1 BOTTLETABLET5002
62135-575-12Hydroxyzine Hydrochloride120 in 1 BOTTLETABLET1202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-575-05EA - Each62135-57531000114-3c90-4bc3-be2d-a1ed1e6f270012023-05-05
62135-575-12EA - Each62135-575414fa63c-5fc0-4000-b0ac-447b7f9cb2f212023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-575HYDROXYZINE HYDROCHLORIDE TABLET [CHARTWELL RX, LLC]1Current NDC, 2 package rows20230416_6533bb4f-efbc-4fca-b625-daa1b3978740.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995218hydrOXYzine HCl 10 MG Oral TabletPSN6533bb4f-efbc-4fca-b625-daa1b39787402
995258hydrOXYzine HCl 25 MG Oral TabletPSN6533bb4f-efbc-4fca-b625-daa1b39787402
995281hydrOXYzine HCl 50 MG Oral TabletPSN6533bb4f-efbc-4fca-b625-daa1b39787402
995218hydroxyzine hydrochloride 10 MG Oral TabletSCD6533bb4f-efbc-4fca-b625-daa1b39787402
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD6533bb4f-efbc-4fca-b625-daa1b39787402
995281hydroxyzine hydrochloride 50 MG Oral TabletSCD6533bb4f-efbc-4fca-b625-daa1b39787402

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-575-0562135057505500 TABLET in 1 BOTTLE (62135-575-05) 500 tablet2023-04-11NoNoHistorical
62135-575-1262135057512120 TABLET in 1 BOTTLE (62135-575-12) 120 tablet2023-04-11NoNoHistorical