FDA.reportPublic FDA data

Hydroxyzine hydrochloride

Product NDC
51655-076
11-digit product format
516550076
Labeler code
51655
Product ID
51655-076_46ddcf32-22fa-3332-e063-6394a90af421
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA204279
Marketing category
ANDA
Marketing start
2020-10-20
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

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-076-522023-04-12C16284748780-1f386c649-ae00-0266-e053-dadaa90a7c1aRx only
51655-076-522023-01-30C16284748780-1f386c649-ae00-0266-e053-dadaa90a7c1aRx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-076-52Hydroxyzine hydrochloride30 in 1 BOTTLE, PLASTICTABLET304
51655-076-54Hydroxyzine hydrochloride15 in 1 BOTTLE, PLASTICTABLET154

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-076HYDROXYZINE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]3Current NDC, Legacy NDC, 2 package rows20240720_c134195e-a048-530a-e053-2a95a90ad9f8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995218hydrOXYzine HCl 10 MG Oral TabletPSNc134195e-a048-530a-e053-2a95a90ad9f84
995218hydroxyzine hydrochloride 10 MG Oral TabletSCDc134195e-a048-530a-e053-2a95a90ad9f84

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51655-076-525165500765230 TABLET in 1 BOTTLE, PLASTIC (51655-076-52) 30 tablet2020-10-200000-00-00NoNoCurrent
51655-076-545165500765415 TABLET in 1 BOTTLE, PLASTIC (51655-076-54) 15 tablet2023-02-27NoNoCurrent