FDA.reportPublic FDA data

HYDROXYZINE HYDROCHLORIDE

Product NDC
51655-078
11-digit product format
516550078
Labeler code
51655
Product ID
51655-078_db5d3eb6-ca9e-4562-bee4-ca54e2c2abc0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROXYZINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Pharmaceuticals, LLC
Application
ANDA040804
Marketing category
ANDA
Marketing start
2014-09-15
Marketing end
0000-00-00
Substance
HYDROXYZINE HYDROCHLORIDE
Active strength
10 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
51655-078-532026-01-10C16284748780-19d75b9d0-a0ab-f424-e053-dadaa90a57ceHYDROXYZINE HYDROCHLORIDE
51655-078-532020-01-31C16284748780-19d75b9d0-a0ab-f424-e053-dadaa90a57ceHYDROXYZINE HYDROCHLORIDE

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROXYZINE HYDROCHLORIDEACTIVE INGREDIENT76755771U3HYDROXYZINE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]1
HYDROXYZINEACTIVE MOIETY30S50YM8OGHYDROXYZINE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-078HYDROXYZINE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]1Legacy NDC20140924_d996def8-01c6-4672-839b-4f5a96505375.zip