FDA.reportPublic FDA data

Hydroxyzine hydrochloride

Product NDC
0904-7378
11-digit product format
009047378
Labeler code
0904
Product ID
0904-7378_462940f7-5dba-4ca2-829d-e0a8a72579e5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA204279
Marketing category
ANDA
Marketing start
2023-08-01
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
0904-7378-40Hydroxyzine hydrochloride500 in 1 BOTTLETABLET5004
0904-7378-80Hydroxyzine hydrochloride1000 in 1 BOTTLETABLET10004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7378HYDROXYZINE HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS]3Current NDC, 2 package rows20250418_7f76580c-96a0-4b56-8986-ff5488bb9869.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995218hydrOXYzine HCl 10 MG Oral TabletPSN7f76580c-96a0-4b56-8986-ff5488bb98694
995258hydrOXYzine HCl 25 MG Oral TabletPSN7f76580c-96a0-4b56-8986-ff5488bb98694
995281hydrOXYzine HCl 50 MG Oral TabletPSN7f76580c-96a0-4b56-8986-ff5488bb98694
995218hydroxyzine hydrochloride 10 MG Oral TabletSCD7f76580c-96a0-4b56-8986-ff5488bb98694
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD7f76580c-96a0-4b56-8986-ff5488bb98694
995281hydroxyzine hydrochloride 50 MG Oral TabletSCD7f76580c-96a0-4b56-8986-ff5488bb98694
995258hydrOXYzine HCl 25 MG Oral TabletPSN1bf88820-e5f9-06e7-e063-6294a90a80ad1
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD1bf88820-e5f9-06e7-e063-6294a90a80ad1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0904-7378-4000904737840500 TABLET in 1 BOTTLE (0904-7378-40) 500 tablet2023-08-01NoNoCurrent
0904-7378-80009047378801000 TABLET in 1 BOTTLE (0904-7378-80) 1000 tablet2023-08-01NoNoCurrent