Hydroxyzine hydrochloride

Product NDC
51407-970
11-digit product format
514070970
Labeler code
51407
Product ID
51407-970_38f9f6f8-8eb8-450b-e063-6394a90a5f38
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
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, 995281

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
51407-970-10Hydroxyzine hydrochloride1000 in 1 BOTTLETABLET10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-970HYDROXYZINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1Current NDC, 1 package rows20250309_2fc9b08a-e675-dbc5-e063-6294a90ad054.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995218hydrOXYzine HCl 10 MG Oral TabletPSN2fc9b08a-e675-dbc5-e063-6294a90ad0542
995258hydrOXYzine HCl 25 MG Oral TabletPSN2fc9b08a-e675-dbc5-e063-6294a90ad0542
995281hydrOXYzine HCl 50 MG Oral TabletPSN2fc9b08a-e675-dbc5-e063-6294a90ad0542
995218hydroxyzine hydrochloride 10 MG Oral TabletSCD2fc9b08a-e675-dbc5-e063-6294a90ad0542
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD2fc9b08a-e675-dbc5-e063-6294a90ad0542
995281hydroxyzine hydrochloride 50 MG Oral TabletSCD2fc9b08a-e675-dbc5-e063-6294a90ad0542

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51407-970-10514070970101000 TABLET in 1 BOTTLE (51407-970-10) 1000 tablet2025-03-04NoNoCurrent