FENOFIBRATE

Product NDC
51655-902
11-digit product format
516550902
Labeler code
51655
Product ID
51655-902_d7f3051c-ff67-40ab-962a-6f03e8d3a4a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FENOFIBRATE
Dosage form
TABLET
Route
ORAL
Labeler
NORTHWIND PHARMACEUTICALS
Application
NDA021656
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2015-04-28
Marketing end
0000-00-00
Substance
FENOFIBRATE
Active strength
145 mg/1
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-902-522026-01-06C16284748780-19d75b9d1-20fa-f424-e053-dadaa90a57ce5b988a9b-04a0-4be7-8936-70edba261bf8
51655-902-522020-01-31C16284748780-19d75b9d1-20fa-f424-e053-dadaa90a57ce5b988a9b-04a0-4be7-8936-70edba261bf8

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FENOFIBRATEACTIVE INGREDIENTU202363UOSFENOFIBRATE TABLET [NORTHWIND PHARMACEUTICALS]1
FENOFIBRATEACTIVE MOIETYU202363UOSFENOFIBRATE TABLET [NORTHWIND PHARMACEUTICALS]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFENOFIBRATE TABLET [NORTHWIND PHARMACEUTICALS]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKFENOFIBRATE TABLET [NORTHWIND PHARMACEUTICALS]1
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0FENOFIBRATE TABLET [NORTHWIND PHARMACEUTICALS]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFENOFIBRATE TABLET [NORTHWIND PHARMACEUTICALS]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFENOFIBRATE TABLET [NORTHWIND PHARMACEUTICALS]1
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62FENOFIBRATE TABLET [NORTHWIND PHARMACEUTICALS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FENOFIBRATE TABLET [NORTHWIND PHARMACEUTICALS]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990FENOFIBRATE TABLET [NORTHWIND PHARMACEUTICALS]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JFENOFIBRATE TABLET [NORTHWIND PHARMACEUTICALS]1
SUCROSEINACTIVE INGREDIENTC151H8M554FENOFIBRATE TABLET [NORTHWIND PHARMACEUTICALS]1
TALCINACTIVE INGREDIENT7SEV7J4R1UFENOFIBRATE TABLET [NORTHWIND PHARMACEUTICALS]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFENOFIBRATE TABLET [NORTHWIND PHARMACEUTICALS]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEFENOFIBRATE TABLET [NORTHWIND PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-902FENOFIBRATE TABLET [NORTHWIND PHARMACEUTICALS]1Legacy NDC20150430_5b988a9b-04a0-4be7-8936-70edba261bf8.zip