FDA.reportPublic FDA data

HYDROXYZINE HYDROCHLORIDE

Product NDC
51655-079
11-digit product format
516550079
Labeler code
51655
Product ID
51655-079_57b04227-0e69-4ada-80ed-2f9e6ccc4e2a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROXYZINE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Northwind Pharmaceuticals, LLC
Application
ANDA040804
Marketing category
ANDA
Marketing start
2015-02-26
Marketing end
0000-00-00
Substance
HYDROXYZINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Antihistamine [EPC],Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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
51655-079-252026-01-08C16284748780-19d75b9d0-cbb3-f424-e053-dadaa90a57ceHYDROXYZINE HYDROCHLORIDE
51655-079-252020-01-31C16284748780-19d75b9d0-cbb3-f424-e053-dadaa90a57ceHYDROXYZINE HYDROCHLORIDE

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROXYZINE HYDROCHLORIDEACTIVE INGREDIENT76755771U3HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]2
HYDROXYZINEACTIVE MOIETY30S50YM8OGHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-079HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]2Legacy NDC20150401_d7d57f7d-6e64-4dca-983f-8c0fa97b5c37.zip