FDA.reportPublic FDA data

Hydroxyzine hydrochloride

Product NDC
50090-2648
11-digit product format
500902648
Labeler code
50090
Product ID
50090-2648_2edc409b-5617-49f2-95d6-4487dc3a230c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA204279
Marketing category
ANDA
Marketing start
2014-08-20
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
Rxcui995218, 995258

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
50090-2648-02023-09-10C16284748780-1f386c649-e3c2-0266-e053-dadaa90a7c1aRx only
50090-2648-12023-09-10C16284748780-1f386c649-e3c2-0266-e053-dadaa90a7c1aRx only
50090-2648-42023-09-10C16284748780-1f386c649-e3c2-0266-e053-dadaa90a7c1aRx only
50090-2648-62023-09-10C16284748780-1f386c649-e3c2-0266-e053-dadaa90a7c1aRx only
50090-2648-02023-01-30C16284748780-1f386c649-e3c2-0266-e053-dadaa90a7c1aRx only
50090-2648-12023-01-30C16284748780-1f386c649-e3c2-0266-e053-dadaa90a7c1aRx only
50090-2648-42023-01-30C16284748780-1f386c649-e3c2-0266-e053-dadaa90a7c1aRx only
50090-2648-62023-01-30C16284748780-1f386c649-e3c2-0266-e053-dadaa90a7c1aRx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2648-0Hydroxyzine hydrochloride20 in 1 BOTTLE, PLASTICTABLET2028
50090-2648-1Hydroxyzine hydrochloride30 in 1 BOTTLETABLET3028
50090-2648-4Hydroxyzine hydrochloride60 in 1 BOTTLETABLET6028
50090-2648-6Hydroxyzine hydrochloride15 in 1 BOTTLETABLET1528

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2648-0EA - Each50090-26489254ff2e-5043-44de-b2f7-c1bc42d1062212021-09-07
50090-2648-1EA - Each50090-2648bc17778a-6ab5-41b3-b8da-667a951e0e9912021-08-05
50090-2648-4EA - Each50090-2648141eae61-9965-427f-80fb-e92e576524b512021-09-07
50090-2648-6EA - Each50090-2648371cf281-8b10-4376-8250-f195733c98a112021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2648HYDROXYZINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]28Current NDC, Legacy NDC, 4 package rows20250516_b52e1759-8be3-4e46-a891-4eaa9270c421.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995218hydrOXYzine HCl 10 MG Oral TabletPSNb52e1759-8be3-4e46-a891-4eaa9270c42128
995258hydrOXYzine HCl 25 MG Oral TabletPSNb52e1759-8be3-4e46-a891-4eaa9270c42128
995218hydroxyzine hydrochloride 10 MG Oral TabletSCDb52e1759-8be3-4e46-a891-4eaa9270c42128
995258hydroxyzine hydrochloride 25 MG Oral TabletSCDb52e1759-8be3-4e46-a891-4eaa9270c42128

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-2648-05009026480020 TABLET in 1 BOTTLE, PLASTIC (50090-2648-0) 20 tablet2014-11-280000-00-00NoNoCurrent
50090-2648-15009026480130 TABLET in 1 BOTTLE (50090-2648-1) 30 tablet2018-11-120000-00-00NoNoCurrent
50090-2648-45009026480460 TABLET in 1 BOTTLE (50090-2648-4) 60 tablet2016-11-280000-00-00NoNoCurrent
50090-2648-65009026480615 TABLET in 1 BOTTLE (50090-2648-6) 15 tablet2018-11-120000-00-00NoNoCurrent