Hydroxyzine hydrochloride

Product NDC
50090-2818
11-digit product format
500902818
Labeler code
50090
Product ID
50090-2818_77cf43e3-5059-4255-83b4-8b66671a2881
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
Marketing end
0000-00-00
Substance
HYDROXYZINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Antihistamine [EPC],Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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
50090-2818-0Hydroxyzine hydrochloride30 in 1 BOTTLETABLET3028
50090-2818-3Hydroxyzine hydrochloride20 in 1 BOTTLE, PLASTICTABLET2028

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2818-0EA - Each50090-28184989c282-109e-4205-a92c-af052ebc846f12018-11-06
50090-2818-3EA - Each50090-281867050094-e961-423e-a721-d294603b802912020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2818HYDROXYZINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]28Legacy NDC, 2 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
50090-2818-05009028180030 TABLET in 1 BOTTLE (50090-2818-0) 30 tablet2017-01-260000-00-00NoNoCurrent
50090-2818-35009028180320 TABLET in 1 BOTTLE, PLASTIC (50090-2818-3) 20 tablet2014-11-280000-00-00NoNoCurrent