FDA.reportPublic FDA data

Hydroxyzine Hydrochloride

Product NDC
81033-031
11-digit product format
810330031
Labeler code
81033
Product ID
81033-031_4cac7248-0970-077a-e063-6294a90a782d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Kesin Pharma
Application
ANDA219289
Marketing category
ANDA
Marketing start
2025-07-17
Substance
HYDROXYZINE DIHYDROCHLORIDE
Active strength
10 mg/5mL
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 DIHYDROCHLORIDE10 mg/5mL

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
81033-031-05Hydroxyzine Hydrochloride5 mL in 1 CUP, UNIT-DOSESOLUTION52
81033-031-12Hydroxyzine Hydrochloride12.5 mL in 1 CUP, UNIT-DOSESOLUTION12.52
81033-031-44Hydroxyzine Hydrochloride40 in 1 CARTONSOLUTION402
81033-031-45Hydroxyzine Hydrochloride40 in 1 CARTONSOLUTION402

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81033-031-05ML - Milliliter81033-031d792c426-65f3-4a59-bc7c-da089105f7be12026-04-20
81033-031-12ML - Milliliter81033-031d75e6d7f-abba-4225-9f70-bb18b58d6ea312026-04-20
81033-031-44ML - Milliliter81033-031c0a022c7-f081-46f7-81ce-460abec27ed912026-04-20
81033-031-45ML - Milliliter81033-0311f586e30-cc21-4d11-91f3-2897b6cb341812026-04-20

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995241hydrOXYzine HCl 10 MG in 5 mL Oral SolutionPSN4b094d1b-97b2-6ca6-e063-6294a90a24372
995241hydroxyzine hydrochloride 2 MG/ML Oral SolutionSCD4b094d1b-97b2-6ca6-e063-6294a90a24372
995241hydroxyzine hydrochloride 10 MG per 5 ML Oral SolutionSY4b094d1b-97b2-6ca6-e063-6294a90a24372

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81033-031-05810330031055 mL in 1 CUP, UNIT-DOSE5 mlHistorical
81033-031-128103300311212.5 mL in 1 CUP, UNIT-DOSE12.5 mlHistorical
81033-031-448103300314440 CUP, UNIT-DOSE in 1 CARTON (81033-031-44) / 5 mL in 1 CUP, UNIT-DOSE (81033-031-05) 2026-02-27NoNoHistorical
81033-031-458103300314540 CUP, UNIT-DOSE in 1 CARTON (81033-031-45) / 12.5 mL in 1 CUP, UNIT-DOSE (81033-031-12) 2026-02-27NoNoHistorical