FDA.reportPublic FDA data

HydrOXYzine Hydrochloride

Product NDC
16714-083
11-digit product format
167140083
Labeler code
16714
Product ID
16714-083_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
50 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 DIHYDROCHLORIDE50 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
16714-083-10HydrOXYzine Hydrochloride100 in 1 BOTTLETABLET10019
16714-083-11HydrOXYzine Hydrochloride500 in 1 BOTTLETABLET50019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-083-04EA - Each16714-083fb08d346-7888-4cb0-b07e-c198fd62b52a12012-07-24
16714-083-05EA - Each16714-083ea0b1c6f-df96-40c4-b96c-7a2353a7e38a12012-07-24
16714-083-10EA - Each16714-08314c212d4-7680-47a1-a64c-cabed21abc2c12013-10-17
16714-083-11EA - Each16714-083eac20784-033b-41f3-a3ca-89f67d92645f12013-10-17

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
16714-083HYDROXYZINE HYDROCHLORIDE TABLET [NORTHSTAR RXLLC]18Current NDC, Legacy NDC, 2 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
995281hydrOXYzine HCl 50 MG Oral TabletPSNbe6a2f09-c0f3-44e2-aac3-37e3702b93f019
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
995281hydroxyzine hydrochloride 50 MG Oral TabletSCDbe6a2f09-c0f3-44e2-aac3-37e3702b93f019
995281hydrOXYzine HCl 50 MG Oral TabletPSN4fb58637-dc30-c4dd-e063-6394a90a8bbe1
995281hydroxyzine hydrochloride 50 MG Oral TabletSCD4fb58637-dc30-c4dd-e063-6394a90a8bbe1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-083-1016714008310100 TABLET in 1 BOTTLE (16714-083-10) 100 tablet2009-11-110000-00-00NoNoCurrent
16714-083-1116714008311500 TABLET in 1 BOTTLE (16714-083-11) 500 tablet2009-11-110000-00-00NoNoCurrent