FDA.reportPublic FDA data

Hydroxyzine Hydrochloride

Product NDC
50090-6655
11-digit product format
500906655
Labeler code
50090
Product ID
50090-6655_55f40911-dfa2-4c85-8faa-a0d9ec530be1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA040602
Marketing category
ANDA
Marketing start
2015-03-31
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-6655-0Hydroxyzine Hydrochloride20 in 1 BOTTLETABLET, FILM COATED202
50090-6655-1Hydroxyzine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED302
50090-6655-4Hydroxyzine Hydrochloride60 in 1 BOTTLETABLET, FILM COATED602
50090-6655-6Hydroxyzine Hydrochloride15 in 1 BOTTLETABLET, FILM COATED152

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6655-0EA - Each50090-6655a9af4b35-fb43-40d1-8751-5b89c96ff9d212023-10-16
50090-6655-1EA - Each50090-66553ec10f19-e824-4d72-bd15-0091df26b89212023-10-16
50090-6655-4EA - Each50090-6655d29598ef-cff9-44cd-a84b-38e0fcc0c5c812023-10-16
50090-6655-6EA - Each50090-66554bc804da-0656-4335-bd2c-42376abd539b12023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6655HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]2Current NDC, 4 package rows20230908_3d5d3ebf-e57e-4ed1-be97-d4b299fb738d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995258hydrOXYzine HCl 25 MG Oral TabletPSN3d5d3ebf-e57e-4ed1-be97-d4b299fb738d2
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD3d5d3ebf-e57e-4ed1-be97-d4b299fb738d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-6655-05009066550020 TABLET, FILM COATED in 1 BOTTLE (50090-6655-0) 2023-08-30NoNoCurrent
50090-6655-15009066550130 TABLET, FILM COATED in 1 BOTTLE (50090-6655-1) 2023-08-30NoNoCurrent
50090-6655-45009066550460 TABLET, FILM COATED in 1 BOTTLE (50090-6655-4) 2023-08-30NoNoCurrent
50090-6655-65009066550615 TABLET, FILM COATED in 1 BOTTLE (50090-6655-6) 2023-08-30NoNoCurrent