FDA.reportPublic FDA data

Hydroxyzine Hydrochloride

Product NDC
60432-150
11-digit product format
604320150
Labeler code
60432
Product ID
60432-150_36313fd7-73e3-403a-8f21-1ff4a0159037
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
SYRUP
Route
ORAL
Labeler
Morton Grove Pharmaceuticals, Inc.
Application
ANDA087294
Marketing category
ANDA
Marketing start
1995-03-09
Marketing end
0000-00-00
Substance
HYDROXYZINE HYDROCHLORIDE
Active strength
10 mg/5mL
Pharmacologic classes
Antihistamine [EPC],Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
57311cfb-679a-da1a-b70c-8757f7fc431aProduct name420250516
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
aa1826f4-97c1-4705-bdf0-3bc7d234e618Product name220190618
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
75cb12ee-8eb2-4f1a-a332-5743a5d0da41Product name120151110
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
3ca5f78b-43dc-30fe-8014-55b922af52b3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60432-150-042023-01-30C16284748780-1f386c649-d672-0266-e053-dadaa90a7c1aHydroxyzine Hydrochloride Oral Solution, USP (Syrup) 10 mg/5 mL Rx only
60432-150-162023-01-30C16284748780-1f386c649-d672-0266-e053-dadaa90a7c1aHydroxyzine Hydrochloride Oral Solution, USP (Syrup) 10 mg/5 mL Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60432-150-04Hydroxyzine Hydrochloride118 mL in 1 BOTTLE, PLASTICSYRUP11811
60432-150-16Hydroxyzine Hydrochloride473 mL in 1 BOTTLE, PLASTICSYRUP47311

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60432-150-04ML - Milliliter60432-15013cbb513-90cf-4622-9c4d-1a6893ce6c2212012-07-24
60432-150-16ML - Milliliter60432-150abd8f01a-2136-4e9c-bd89-effce2b507eb12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Hydroxyzine HydrochlorideACTIVE INGREDIENT76755771U3HYDROXYZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]6
HydroxyzineACTIVE MOIETY30S50YM8OGHYDROXYZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]6
alcoholINACTIVE INGREDIENT3K9958V90MHYDROXYZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]6
Anhydrous Citric AcidINACTIVE INGREDIENTXF417D3PSLHYDROXYZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]6
methylparabenINACTIVE INGREDIENTA2I8C7HI9THYDROXYZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]6
peppermint oilINACTIVE INGREDIENTAV092KU4JHHYDROXYZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]6
propylene glycolINACTIVE INGREDIENT6DC9Q167V3HYDROXYZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]6
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHHYDROXYZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]6
spearmint oilINACTIVE INGREDIENTC3M81465G5HYDROXYZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]6
Trisodium Citrate DihydrateINACTIVE INGREDIENTB22547B95KHYDROXYZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]6
waterINACTIVE INGREDIENT059QF0KO0RHYDROXYZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]6
HYDROXYZINE HYDROCHLORIDEACTIVE INGREDIENT76755771U3HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) SYRUP [PHYSICIANS TOTAL CARE, INC.]2
HYDROXYZINEACTIVE MOIETY30S50YM8OGHYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) SYRUP [PHYSICIANS TOTAL CARE, INC.]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MHYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) SYRUP [PHYSICIANS TOTAL CARE, INC.]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9THYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) SYRUP [PHYSICIANS TOTAL CARE, INC.]2
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JHHYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) SYRUP [PHYSICIANS TOTAL CARE, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) SYRUP [PHYSICIANS TOTAL CARE, INC.]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHHYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) SYRUP [PHYSICIANS TOTAL CARE, INC.]2
SPEARMINT OILINACTIVE INGREDIENTC3M81465G5HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) SYRUP [PHYSICIANS TOTAL CARE, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RHYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) SYRUP [PHYSICIANS TOTAL CARE, INC.]2
Hydroxyzine HydrochlorideACTIVE INGREDIENT76755771U3HYDROXYZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP]1
HydroxyzineACTIVE MOIETY30S50YM8OGHYDROXYZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP]1
alcoholINACTIVE INGREDIENT3K9958V90MHYDROXYZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP]1
Anhydrous Citric AcidINACTIVE INGREDIENTXF417D3PSLHYDROXYZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP]1
methylparabenINACTIVE INGREDIENTA2I8C7HI9THYDROXYZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP]1
peppermint oilINACTIVE INGREDIENTAV092KU4JHHYDROXYZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3HYDROXYZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP]1
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHHYDROXYZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP]1
spearmint oilINACTIVE INGREDIENTC3M81465G5HYDROXYZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP]1
Trisodium Citrate DihydrateINACTIVE INGREDIENTB22547B95KHYDROXYZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP]1
waterINACTIVE INGREDIENT059QF0KO0RHYDROXYZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60432-150HYDROXYZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]11Legacy NDC, 2 package rows20181214_117aeccc-1a78-46d8-ad8d-4035870ad910.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995241hydrOXYzine HCl 10 MG in 5 mL Oral SolutionPSN117aeccc-1a78-46d8-ad8d-4035870ad91011
995241hydroxyzine hydrochloride 2 MG/ML Oral SolutionSCD117aeccc-1a78-46d8-ad8d-4035870ad91011
995241hydroxyzine hydrochloride 10 MG per 5 ML Oral SolutionSY117aeccc-1a78-46d8-ad8d-4035870ad91011
995241hydrOXYzine HCl 10 MG in 5 mL Oral SolutionPSNbcddc5ce-6cfb-4a09-8e6c-c956b65e31885
995241hydroxyzine hydrochloride 2 MG/ML Oral SolutionSCDbcddc5ce-6cfb-4a09-8e6c-c956b65e31885
995241hydroxyzine hydrochloride 10 MG per 5 ML Oral SolutionSYbcddc5ce-6cfb-4a09-8e6c-c956b65e31885
995241hydrOXYzine HCl 10 MG in 5 mL Oral SolutionPSN25609c5f-953f-4434-938a-e3f01069893e4
995241hydroxyzine hydrochloride 2 MG/ML Oral SolutionSCD25609c5f-953f-4434-938a-e3f01069893e4
995241hydroxyzine hydrochloride 10 MG per 5 ML Oral SolutionSY25609c5f-953f-4434-938a-e3f01069893e4
995241hydrOXYzine HCl 10 MG in 5 mL Oral SolutionPSN6350ea7f-a145-4e22-9c9a-f10beae5cc712
995241hydrOXYzine HCl 10 MG in 5 mL Oral SolutionPSN989107f5-e3df-4519-98bc-3b6ed290758f2
995241hydroxyzine hydrochloride 2 MG/ML Oral SolutionSCD6350ea7f-a145-4e22-9c9a-f10beae5cc712
995241hydroxyzine hydrochloride 2 MG/ML Oral SolutionSCD989107f5-e3df-4519-98bc-3b6ed290758f2
995241hydroxyzine hydrochloride 10 MG per 5 ML Oral SolutionSY6350ea7f-a145-4e22-9c9a-f10beae5cc712
995241hydroxyzine hydrochloride 10 MG per 5 ML Oral SolutionSY989107f5-e3df-4519-98bc-3b6ed290758f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60432-150-0460432015004118 mL in 1 BOTTLE, PLASTIC (60432-150-04) 118 ml1995-03-090000-00-00NoNoCurrent
60432-150-1660432015016473 mL in 1 BOTTLE, PLASTIC (60432-150-16) 473 ml1995-03-090000-00-00NoNoCurrent