FDA.reportPublic FDA data

HydrOXYzine Hydrochloride

Product NDC
16714-082
11-digit product format
167140082
Labeler code
16714
Product ID
16714-082_1a8febc0-9d51-4026-8ea6-6cba69e841c5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HydrOXYzine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Northstar RxLLC
Application
ANDA040840
Marketing category
ANDA
Marketing start
2009-11-11
Substance
HYDROXYZINE DIHYDROCHLORIDE
Active strength
25 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 DIHYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii76755771U3
Rxcui995218, 995258, 995281

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
16714-082-10HydrOXYzine Hydrochloride100 in 1 BOTTLETABLET10019
16714-082-11HydrOXYzine Hydrochloride500 in 1 BOTTLETABLET50019
16714-082-12HydrOXYzine Hydrochloride1000 in 1 BOTTLETABLET100019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-082-04EA - Each16714-082da8db88e-e5d7-4f30-8258-be17f1111a8212012-07-24
16714-082-05EA - Each16714-0827f3cf018-8c9b-4d7c-9859-6606747dfb3412012-07-24
16714-082-06EA - Each16714-082452fbb51-342a-45c5-82ee-7dd64e6d990412012-07-24
16714-082-10EA - Each16714-0828abc36ef-c58f-463d-8842-61daa04d62a912013-10-17
16714-082-11EA - Each16714-08285511cb8-8dbe-4016-89b7-205295aab37612013-10-17
16714-082-12EA - Each16714-082a9e82ee8-4558-4c67-a40b-bf0bcb93eb7e12013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HydrOXYzine HydrochlorideACTIVE INGREDIENT76755771U3HYDROXYZINE HYDROCHLORIDE TABLET [NORTHSTAR RXLLC]10
hydrOXYzineACTIVE MOIETY30S50YM8OGHYDROXYZINE HYDROCHLORIDE TABLET [NORTHSTAR RXLLC]10
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKHYDROXYZINE HYDROCHLORIDE TABLET [NORTHSTAR RXLLC]10
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROXYZINE HYDROCHLORIDE TABLET [NORTHSTAR RXLLC]10
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYDROXYZINE HYDROCHLORIDE TABLET [NORTHSTAR RXLLC]10
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOHYDROXYZINE HYDROCHLORIDE TABLET [NORTHSTAR RXLLC]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROXYZINE HYDROCHLORIDE TABLET [NORTHSTAR RXLLC]10
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AHYDROXYZINE HYDROCHLORIDE TABLET [NORTHSTAR RXLLC]10
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HHYDROXYZINE HYDROCHLORIDE TABLET [NORTHSTAR RXLLC]10
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROXYZINE HYDROCHLORIDE TABLET [NORTHSTAR RXLLC]10
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HYDROXYZINE HYDROCHLORIDE TABLET [NORTHSTAR RXLLC]10
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROXYZINE HYDROCHLORIDE TABLET [NORTHSTAR RXLLC]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROXYZINE HYDROCHLORIDE TABLET [NORTHSTAR RXLLC]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-082HYDROXYZINE HYDROCHLORIDE TABLET [NORTHSTAR RXLLC]18Current NDC, Legacy NDC, 3 package rows20250206_8e5fce17-936e-46ea-a969-518c952c2091.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995218hydrOXYzine HCl 10 MG Oral TabletPSN8e5fce17-936e-46ea-a969-518c952c209119
995258hydrOXYzine HCl 25 MG Oral TabletPSN8e5fce17-936e-46ea-a969-518c952c209119
995281hydrOXYzine HCl 50 MG Oral TabletPSN8e5fce17-936e-46ea-a969-518c952c209119
995218hydroxyzine hydrochloride 10 MG Oral TabletSCD8e5fce17-936e-46ea-a969-518c952c209119
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD8e5fce17-936e-46ea-a969-518c952c209119
995281hydroxyzine hydrochloride 50 MG Oral TabletSCD8e5fce17-936e-46ea-a969-518c952c209119
995258hydrOXYzine HCl 25 MG Oral TabletPSNacc99b8f-87f0-eb3a-e053-2995a90aaaed6
995258hydroxyzine hydrochloride 25 MG Oral TabletSCDacc99b8f-87f0-eb3a-e053-2995a90aaaed6
995258hydrOXYzine HCl 25 MG Oral TabletPSN723b810b-46cc-4c45-ae1f-93ca358e007d5
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD723b810b-46cc-4c45-ae1f-93ca358e007d5
995258hydrOXYzine HCl 25 MG Oral TabletPSN46266803-0905-4ae2-9d17-dbf4c2a081813
995258hydrOXYzine HCl 25 MG Oral TabletPSN8698bfa7-dbde-c9c8-e053-2991aa0a21963
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD46266803-0905-4ae2-9d17-dbf4c2a081813
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD8698bfa7-dbde-c9c8-e053-2991aa0a21963
995258hydrOXYzine HCl 25 MG Oral TabletPSNffd33207-3f35-3486-e053-6394a90ac0ae2
995258hydrOXYzine HCl 25 MG Oral TabletPSN3d2e63c6-993c-42b9-91a0-616246789a7b2
995258hydroxyzine hydrochloride 25 MG Oral TabletSCDffd33207-3f35-3486-e053-6394a90ac0ae2
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD3d2e63c6-993c-42b9-91a0-616246789a7b2
995258hydrOXYzine HCl 25 MG Oral TabletPSN8e954579-b0f5-4ce3-bade-0b9b972f6f8b1
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD8e954579-b0f5-4ce3-bade-0b9b972f6f8b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-082-1016714008210100 TABLET in 1 BOTTLE (16714-082-10) 100 tablet2009-11-110000-00-00NoNoCurrent
16714-082-1116714008211500 TABLET in 1 BOTTLE (16714-082-11) 500 tablet2009-11-110000-00-00NoNoCurrent
16714-082-12167140082121000 TABLET in 1 BOTTLE (16714-082-12) 1000 tablet2009-11-110000-00-00NoNoCurrent