FDA.reportPublic FDA data

Hydroxyzine Hydrochloride

Product NDC
0517-4201
11-digit product format
005174201
Labeler code
0517
Product ID
0517-4201_83de333d-1bf1-4168-8614-6bc79c26d5d0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
American Regent, Inc.
Application
ANDA087408
Marketing category
ANDA
Marketing start
1990-09-30
Substance
HYDROXYZINE DIHYDROCHLORIDE
Active strength
25 mg/mL
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/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii76755771U3
Rxcui995270, 995285, 1794552, 1794554

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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0517-4201-01Hydroxyzine Hydrochloride1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION118
0517-4201-25Hydroxyzine Hydrochloride25 in 1 TRAYINJECTION, SOLUTION2518

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0517-4201-01ML - Milliliter0517-42019d61d775-5595-4e2f-9a5e-48f59c15c54212025-09-12
0517-4201-25ML - Milliliter0517-4201272c0a4a-7d8b-43f7-a61c-5bc0a88a1f1912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROXYZINE HYDROCHLORIDEACTIVE INGREDIENT76755771U3HYDROXYZINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.]8
HYDROXYZINEACTIVE MOIETY30S50YM8OGHYDROXYZINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.]8
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHHYDROXYZINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.]8
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBHYDROXYZINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.]8
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IHYDROXYZINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.]8
WATERINACTIVE INGREDIENT059QF0KO0RHYDROXYZINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0517-4201HYDROXYZINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.]17Current NDC, Legacy NDC, 2 package rows20240607_8af7e5ce-d9d9-44cc-9f2f-4ddbc89e758a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1794552hydrOXYzine HCl 100 MG in 2 ML InjectionPSN8af7e5ce-d9d9-44cc-9f2f-4ddbc89e758a18
995270hydrOXYzine HCl 25 MG in 1 ML InjectionPSN8af7e5ce-d9d9-44cc-9f2f-4ddbc89e758a18
1794554hydrOXYzine HCl 50 MG in 1 ML InjectionPSN8af7e5ce-d9d9-44cc-9f2f-4ddbc89e758a18
995285hydrOXYzine HCl 50 MG/ML Injectable SolutionPSN8af7e5ce-d9d9-44cc-9f2f-4ddbc89e758a18
9952701 ML hydroxyzine hydrochloride 25 MG/ML InjectionSCD8af7e5ce-d9d9-44cc-9f2f-4ddbc89e758a18
17945541 ML hydroxyzine hydrochloride 50 MG/ML InjectionSCD8af7e5ce-d9d9-44cc-9f2f-4ddbc89e758a18
17945522 ML hydroxyzine hydrochloride 50 MG/ML InjectionSCD8af7e5ce-d9d9-44cc-9f2f-4ddbc89e758a18
995285hydroxyzine hydrochloride 50 MG/ML Injectable SolutionSCD8af7e5ce-d9d9-44cc-9f2f-4ddbc89e758a18
1794552hydroxyzine hydrochloride 100 MG per 2 ML InjectionSY8af7e5ce-d9d9-44cc-9f2f-4ddbc89e758a18
995270hydroxyzine hydrochloride 25 MG per 1 ML InjectionSY8af7e5ce-d9d9-44cc-9f2f-4ddbc89e758a18
1794554hydroxyzine hydrochloride 50 MG per 1 ML InjectionSY8af7e5ce-d9d9-44cc-9f2f-4ddbc89e758a18
995270hydrOXYzine HCl 25 MG in 1 ML InjectionPSN16a63845-6619-293b-e063-6394a90a0a5c2
9952701 ML hydroxyzine hydrochloride 25 MG/ML InjectionSCD16a63845-6619-293b-e063-6394a90a0a5c2
995270hydroxyzine hydrochloride 25 MG per 1 ML InjectionSY16a63845-6619-293b-e063-6394a90a0a5c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0517-4201-01005174201011 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical
0517-4201-250051742012525 VIAL, SINGLE-DOSE in 1 TRAY (0517-4201-25) / 1 mL in 1 VIAL, SINGLE-DOSE (0517-4201-01) 1990-09-300000-00-00NoNoCurrent