FDA.reportPublic FDA data

Fenofibrate

Product NDC
51655-010
11-digit product format
516550010
Labeler code
51655
Product ID
51655-010_fcef12aa-ba34-4a2c-abdd-9447cc18f3ac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fenofibrate
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Pharmaceuticals
Application
NDA021656
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2014-05-20
Marketing end
0000-00-00
Substance
FENOFIBRATE
Active strength
145 mg/301
Pharmacologic classes
Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
193bb7da-5c03-8f95-9048-23ef403846b0Product name320250616
fa35fb9a-7146-716b-13c8-bc1f60030232Product name920250114
cfc78bfa-7d55-47e5-aeb7-71cd79f5ca07Product name820231212
ed9d55d4-85bd-0ee7-5b4a-b705646a3a66Product name920200708
36a239c8-03fb-0083-81af-6c1afb195671Product name120140508
a0296d70-ca85-018c-84e8-cf3f630976b7Product name120140508
f2e3e9c8-a2f9-0cc3-a5a5-6dfd0279372aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-010-522026-01-10C16284748780-19d75b9d0-d369-f424-e053-dadaa90a57cedbc61583-082b-4e69-8147-0de0ae72016f
51655-010-522020-01-31C16284748780-19d75b9d0-d369-f424-e053-dadaa90a57cedbc61583-082b-4e69-8147-0de0ae72016f

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51655-010-52EA - Each51655-0101007d8e0-a55e-4b65-9b47-2887c91ce26212015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FENOFIBRATEACTIVE INGREDIENTU202363UOSFENOFIBRATE TABLET [NORTHWIND PHARMACEUTICALS]1
FENOFIBRATEACTIVE MOIETYU202363UOSFENOFIBRATE TABLET [NORTHWIND PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-010FENOFIBRATE TABLET [NORTHWIND PHARMACEUTICALS]1Legacy NDC20140520_dbc61583-082b-4e69-8147-0de0ae72016f.zip