Hydroxyzine hydrochloride

Product NDC
50090-5297
11-digit product format
500905297
Labeler code
50090
Product ID
50090-5297_7a2ede87-19fc-48d6-b54e-43ad660187ab
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5297-02023-06-20C16284748780-1f386c64a-26bc-0266-e053-dadaa90a7c1aRx only
50090-5297-02023-01-30C16284748780-1f386c64a-26bc-0266-e053-dadaa90a7c1aRx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5297-0Hydroxyzine hydrochloride90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5297-0EA - Each50090-5297d8dd5117-6b9e-4536-911e-b4ce02b1894312023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5297HYDROXYZINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]4Current NDC, Legacy NDC, 1 package rows20230621_92d8cc57-7e3a-4217-9160-e1b56db5570e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995258hydrOXYzine HCl 25 MG Oral TabletPSN92d8cc57-7e3a-4217-9160-e1b56db5570e4
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD92d8cc57-7e3a-4217-9160-e1b56db5570e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5297-05009052970090 TABLET in 1 BOTTLE (50090-5297-0) 90 tablet2020-10-260000-00-00NoNoCurrent