FDA.reportPublic FDA data

HYDROXYZINE HYDROCHLORIDE

Product NDC
62135-050
11-digit product format
621350050
Labeler code
62135
Product ID
62135-050_25117412-3663-105d-e063-6394a90a0d64
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROXYZINE HYDROCHLORIDE
Dosage form
SYRUP
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA087294
Marketing category
ANDA
Marketing start
1982-04-12
Substance
HYDROXYZINE DIHYDROCHLORIDE
Active strength
50 mg/25mL
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 DIHYDROCHLORIDE50 mg/25mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii76755771U3
Rxcui995241

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
62135-050-24HYDROXYZINE HYDROCHLORIDE2 in 1 BOXSYRUP23
62135-050-24HYDROXYZINE HYDROCHLORIDE10 in 1 TRAYSYRUP103
62135-050-52HYDROXYZINE HYDROCHLORIDE25 mL in 1 CUPSYRUP253

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-050-24ML - Milliliter62135-05010ab8d7b-29c6-4507-a58d-7ab1ae23f33a12024-11-05
62135-050-52ML - Milliliter62135-05068d32085-f93b-4219-af78-5fe63d1d73e312024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-050HYDROXYZINE HYDROCHLORIDE SYRUP [CHARTWELL RX, LLC]3Current NDC, 3 package rows20241024_53b2d731-f38a-47c0-9e5c-abd3b45e2fe1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995241hydrOXYzine HCl 10 MG in 5 mL Oral SolutionPSN53b2d731-f38a-47c0-9e5c-abd3b45e2fe13
995241hydroxyzine hydrochloride 2 MG/ML Oral SolutionSCD53b2d731-f38a-47c0-9e5c-abd3b45e2fe13
995241hydroxyzine hydrochloride 10 MG per 5 ML Oral SolutionSY53b2d731-f38a-47c0-9e5c-abd3b45e2fe13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-050-24621350050242 TRAY in 1 BOX (62135-050-24) / 10 CUP in 1 TRAY / 25 mL in 1 CUP (62135-050-52) 2 tray2024-09-23NoNoCurrent
62135-050-526213500505225 mL in 1 CUP25 mlHistorical