FDA.reportPublic FDA data

Hydroxyzine hydrochloride

Product NDC
0615-8082
11-digit product format
006158082
Labeler code
0615
Product ID
0615-8082_1ab953e6-830e-4845-8cca-9864f8002cdf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
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
0615-8082-05Hydroxyzine hydrochloride15 in 1 BLISTER PACKTABLET1524
0615-8082-28Hydroxyzine hydrochloride28 in 1 BLISTER PACKTABLET2824
0615-8082-39Hydroxyzine hydrochloride30 in 1 BLISTER PACKTABLET3024

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-8082HYDROXYZINE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]24Current NDC, Legacy NDC, 3 package rows20250326_0c687cbe-ce40-4bc0-b880-5166b5be7a80.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995218hydrOXYzine HCl 10 MG Oral TabletPSN0c687cbe-ce40-4bc0-b880-5166b5be7a8024
995258hydrOXYzine HCl 25 MG Oral TabletPSN0c687cbe-ce40-4bc0-b880-5166b5be7a8024
995281hydrOXYzine HCl 50 MG Oral TabletPSN0c687cbe-ce40-4bc0-b880-5166b5be7a8024
995218hydroxyzine hydrochloride 10 MG Oral TabletSCD0c687cbe-ce40-4bc0-b880-5166b5be7a8024
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD0c687cbe-ce40-4bc0-b880-5166b5be7a8024
995281hydroxyzine hydrochloride 50 MG Oral TabletSCD0c687cbe-ce40-4bc0-b880-5166b5be7a8024

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0615-8082-050061580820515 TABLET in 1 BLISTER PACK (0615-8082-05) 15 tablet2022-10-280000-00-00NoNoCurrent
0615-8082-280061580822828 TABLET in 1 BLISTER PACK (0615-8082-28) 28 tablet2024-03-28NoNoCurrent
0615-8082-390061580823930 TABLET in 1 BLISTER PACK (0615-8082-39) 30 tablet2016-12-200000-00-00NoNoCurrent