FDA.reportPublic FDA data

Hydroxyzine hydrochloride

Product NDC
50090-6293
11-digit product format
500906293
Labeler code
50090
Product ID
50090-6293_f2d8a028-a3ac-4c12-8a76-77df0e4c1634
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA204279
Marketing category
ANDA
Marketing start
2014-08-20
Substance
HYDROXYZINE DIHYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hydroxyzine hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROXYZINE DIHYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii76755771U3
Rxcui995281

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
50090-6293-1Hydroxyzine hydrochloride30 in 1 BOTTLETABLET3026
50090-6293-4Hydroxyzine hydrochloride25 in 1 BOTTLETABLET2526

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6293-1EA - Each50090-6293f61d2a80-0d41-4f22-9d79-c4f00f356cee12023-03-13
50090-6293-4EA - Each50090-62932532e6ca-218c-4b46-9285-f25ec08aea8012023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6293HYDROXYZINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]24Current NDC, 2 package rows20230219_1350964e-663e-4a50-8c4c-cda371a694a0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995281hydrOXYzine HCl 50 MG Oral TabletPSN1350964e-663e-4a50-8c4c-cda371a694a026
995281hydroxyzine hydrochloride 50 MG Oral TabletSCD1350964e-663e-4a50-8c4c-cda371a694a026

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6293-15009062930130 TABLET in 1 BOTTLE (50090-6293-1) 30 tablet2022-12-22NoNoHistorical
50090-6293-45009062930425 TABLET in 1 BOTTLE (50090-6293-4) 25 tablet2022-12-22NoNoHistorical