FDA.reportPublic FDA data

HYDROXYZINE HYDROCHLORIDE

Product NDC
50090-7330
11-digit product format
500907330
Labeler code
50090
Product ID
50090-7330_4278def4-d310-40ba-a058-2b4f21b9d8ec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydroxyzine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA217652
Marketing category
ANDA
Marketing start
2023-08-22
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
50090-7330-0HYDROXYZINE HYDROCHLORIDE20 in 1 BOTTLETABLET, FILM COATED203
50090-7330-1HYDROXYZINE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED303
50090-7330-4HYDROXYZINE HYDROCHLORIDE60 in 1 BOTTLETABLET, FILM COATED603
50090-7330-6HYDROXYZINE HYDROCHLORIDE15 in 1 BOTTLETABLET, FILM COATED153

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7330-0EA - Each50090-733062dd50df-846d-478f-9734-3a984b4a349612024-11-05
50090-7330-1EA - Each50090-7330f8e33fd4-8767-4ca0-97fe-647dca0f8d8412024-11-05
50090-7330-4EA - Each50090-7330159ba805-8b8e-49c3-92b0-51b2c77228d912024-11-05
50090-7330-6EA - Each50090-73308e9d7c20-ac07-4259-878d-6822b3218d0c12024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7330HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]1Current NDC, 4 package rows20241023_69a58bc6-c8a4-48ad-ac77-90fac42e0398.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995258hydrOXYzine HCl 25 MG Oral TabletPSN69a58bc6-c8a4-48ad-ac77-90fac42e03983
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD69a58bc6-c8a4-48ad-ac77-90fac42e03983

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7330-05009073300020 TABLET, FILM COATED in 1 BOTTLE (50090-7330-0) 2024-10-15NoNoCurrent
50090-7330-15009073300130 TABLET, FILM COATED in 1 BOTTLE (50090-7330-1) 2024-10-15NoNoCurrent
50090-7330-45009073300460 TABLET, FILM COATED in 1 BOTTLE (50090-7330-4) 2024-10-15NoNoCurrent
50090-7330-65009073300615 TABLET, FILM COATED in 1 BOTTLE (50090-7330-6) 2024-10-15NoNoCurrent