FDA.reportPublic FDA data

HydrOXYzine Hydrochloride

Product NDC
50090-6682
11-digit product format
500906682
Labeler code
50090
Product ID
50090-6682_513396a5-9d16-4198-bff7-b966a546bc51
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HydrOXYzine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA040840
Marketing category
ANDA
Marketing start
2009-11-11
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

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
50090-6682-0HydrOXYzine Hydrochloride30 in 1 BOTTLETABLET306
50090-6682-3HydrOXYzine Hydrochloride20 in 1 BOTTLETABLET206

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6682-0EA - Each50090-6682af1a7fbf-ec08-44a4-9e21-659401117a6212023-10-16
50090-6682-3EA - Each50090-66822b994a78-9cd6-499d-ba6e-01eea2de118212023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6682HYDROXYZINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]4Current NDC, 2 package rows20230915_5dea636d-dee6-47d4-b83c-b9f0c0b1b6ca.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995218hydrOXYzine HCl 10 MG Oral TabletPSN5dea636d-dee6-47d4-b83c-b9f0c0b1b6ca6
995218hydroxyzine hydrochloride 10 MG Oral TabletSCD5dea636d-dee6-47d4-b83c-b9f0c0b1b6ca6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6682-05009066820030 TABLET in 1 BOTTLE (50090-6682-0) 30 tablet2023-09-13NoNoHistorical
50090-6682-35009066820320 TABLET in 1 BOTTLE (50090-6682-3) 20 tablet2023-09-13NoNoHistorical