FDA.reportPublic FDA data

HydrOXYzine Hydrochloride

Product NDC
50090-2614
11-digit product format
500902614
Labeler code
50090
Product ID
50090-2614_18cd1ec0-5aa3-4bb3-8415-ef4d9079e190
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
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
Rxcui995281

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-2614-12024-05-28C16284748780-1f386c649-d0c1-0266-e053-dadaa90a7c1aRx Only
50090-2614-32024-05-28C16284748780-1f386c649-d0c1-0266-e053-dadaa90a7c1aRx Only
50090-2614-42024-05-28C16284748780-1f386c649-d0c1-0266-e053-dadaa90a7c1aRx Only
50090-2614-12023-01-30C16284748780-1f386c649-d0c1-0266-e053-dadaa90a7c1aRx Only
50090-2614-32023-01-30C16284748780-1f386c649-d0c1-0266-e053-dadaa90a7c1aRx Only
50090-2614-42023-01-30C16284748780-1f386c649-d0c1-0266-e053-dadaa90a7c1aRx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2614-0HydrOXYzine Hydrochloride100 in 1 BOTTLETABLET10019
50090-2614-1HydrOXYzine Hydrochloride30 in 1 BOTTLETABLET3019
50090-2614-3HydrOXYzine Hydrochloride17 in 1 BOTTLETABLET1719
50090-2614-4HydrOXYzine Hydrochloride25 in 1 BOTTLETABLET2519

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2614-1EA - Each50090-26140c867062-7df7-4b52-843a-b059511f5f3612019-04-11
50090-2614-4EA - Each50090-2614963f30bc-3f18-4622-bac1-ba56f99cf3b312021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2614HYDROXYZINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]19Current NDC, Legacy NDC, 4 package rows20240530_be6a2f09-c0f3-44e2-aac3-37e3702b93f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995281hydrOXYzine HCl 50 MG Oral TabletPSNbe6a2f09-c0f3-44e2-aac3-37e3702b93f019
995281hydroxyzine hydrochloride 50 MG Oral TabletSCDbe6a2f09-c0f3-44e2-aac3-37e3702b93f019

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-2614-050090261400100 TABLET in 1 BOTTLE (50090-2614-0) 100 tablet2018-10-19NoNoHistorical
50090-2614-15009026140130 TABLET in 1 BOTTLE (50090-2614-1) 30 tablet2016-11-110000-00-00NoNoCurrent
50090-2614-35009026140317 TABLET in 1 BOTTLE (50090-2614-3) 17 tablet2018-08-070000-00-00NoNoCurrent
50090-2614-45009026140425 TABLET in 1 BOTTLE (50090-2614-4) 25 tablet2018-08-070000-00-00NoNoCurrent