FDA.reportPublic FDA data

HydrOXYzine Hydrochloride

Product NDC
16714-081
11-digit product format
167140081
Labeler code
16714
Product ID
16714-081_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
10 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 DIHYDROCHLORIDE10 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
16714-081-10HydrOXYzine Hydrochloride100 in 1 BOTTLETABLET10019
16714-081-11HydrOXYzine Hydrochloride500 in 1 BOTTLETABLET50019

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-081HYDROXYZINE 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
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
995218hydrOXYzine HCl 10 MG Oral TabletPSN5dea636d-dee6-47d4-b83c-b9f0c0b1b6ca6
995218hydroxyzine hydrochloride 10 MG Oral TabletSCD5dea636d-dee6-47d4-b83c-b9f0c0b1b6ca6
995218hydrOXYzine HCl 10 MG Oral TabletPSN58d99cf6-2319-410b-b8be-de9c304541b61
995218hydrOXYzine HCl 10 MG Oral TabletPSNebf3edb9-898c-1dcc-e053-2995a90a911b1
995218hydroxyzine hydrochloride 10 MG Oral TabletSCD58d99cf6-2319-410b-b8be-de9c304541b61
995218hydroxyzine hydrochloride 10 MG Oral TabletSCDebf3edb9-898c-1dcc-e053-2995a90a911b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-081-1016714008110100 TABLET in 1 BOTTLE (16714-081-10) 100 tablet2009-11-110000-00-00NoNoCurrent
16714-081-1116714008111500 TABLET in 1 BOTTLE (16714-081-11) 500 tablet2009-11-110000-00-00NoNoCurrent