FDA.reportPublic FDA data

HydrOXYzine Hydrochloride

Product NDC
68071-2237
11-digit product format
680712237
Labeler code
68071
Product ID
68071-2237_440bf439-8d43-df89-e063-6294a90ab70b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HydrOXYzine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA040840
Marketing category
ANDA
Marketing start
2009-11-11
Substance
HYDROXYZINE DIHYDROCHLORIDE
Active strength
25 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 DIHYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii76755771U3
Rxcui995258

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
68071-2237-2HydrOXYzine Hydrochloride20 in 1 BOTTLETABLET206
68071-2237-3HydrOXYzine Hydrochloride30 in 1 BOTTLETABLET306
68071-2237-5HydrOXYzine Hydrochloride15 in 1 BOTTLETABLET156

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2237HYDROXYZINE HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS,INC.]5Current NDC, Legacy NDC, 3 package rows20240719_acc99b8f-87f0-eb3a-e053-2995a90aaaed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995258hydrOXYzine HCl 25 MG Oral TabletPSNacc99b8f-87f0-eb3a-e053-2995a90aaaed6
995258hydroxyzine hydrochloride 25 MG Oral TabletSCDacc99b8f-87f0-eb3a-e053-2995a90aaaed6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2237-26807122370220 TABLET in 1 BOTTLE (68071-2237-2) 20 tablet2020-08-130000-00-00NoNoCurrent
68071-2237-36807122370330 TABLET in 1 BOTTLE (68071-2237-3) 30 tablet2020-08-130000-00-00NoNoCurrent
68071-2237-56807122370515 TABLET in 1 BOTTLE (68071-2237-5) 15 tablet2025-11-20NoNoCurrent