FDA.reportPublic FDA data

Hydroxyzine hydrochloride

Product NDC
51655-080
11-digit product format
516550080
Labeler code
51655
Product ID
51655-080_46ddd139-5487-4c55-e063-6294a90a6f64
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
2020-12-10
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
Rxcui995258

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
51655-080-20Hydroxyzine hydrochloride20 in 1 BOTTLE, PLASTICTABLET205
51655-080-25Hydroxyzine hydrochloride60 in 1 BOTTLE, PLASTICTABLET605
51655-080-52Hydroxyzine hydrochloride30 in 1 BOTTLE, PLASTICTABLET305
51655-080-53Hydroxyzine hydrochloride10 in 1 BOTTLE, PLASTICTABLET105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-080HYDROXYZINE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]4Current NDC, Legacy NDC, 4 package rows20240720_c13455a3-3078-4fe1-e053-2a95a90adf8e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995258hydrOXYzine HCl 25 MG Oral TabletPSNc13455a3-3078-4fe1-e053-2a95a90adf8e5
995258hydroxyzine hydrochloride 25 MG Oral TabletSCDc13455a3-3078-4fe1-e053-2a95a90adf8e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51655-080-205165500802020 TABLET in 1 BOTTLE, PLASTIC (51655-080-20) 20 tablet2021-04-200000-00-00NoNoCurrent
51655-080-255165500802560 TABLET in 1 BOTTLE, PLASTIC (51655-080-25) 60 tablet2022-04-150000-00-00NoNoCurrent
51655-080-525165500805230 TABLET in 1 BOTTLE, PLASTIC (51655-080-52) 30 tablet2020-12-100000-00-00NoNoCurrent
51655-080-535165500805310 TABLET in 1 BOTTLE, PLASTIC (51655-080-53) 10 tablet2023-09-13NoNoCurrent