FDA.reportPublic FDA data

Fenofibrate

Product NDC
68151-4718
11-digit product format
681514718
Labeler code
68151
Product ID
68151-4718_491f9aad-a030-4be5-88b0-51e189ca9374
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fenofibrate
Dosage form
TABLET
Route
ORAL
Labeler
Carilion Materials Management
Application
NDA021656
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2004-11-05
Marketing end
0000-00-00
Substance
FENOFIBRATE
Active strength
48 mg/1
Pharmacologic classes
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
53d5b6b7-785a-4500-9460-263c7f8424b8Product name520210105
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
68151-4718-92020-01-31C16284748780-19d75b9d0-fcc1-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Fenofibrate tablets for oral use safely and effectively. See full prescribing information for Fenofibrate tablets for oral use. Fenofibrate Tablets for oral use Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68151-4718-9Fenofibrate1 in 1 PACKAGETABLET13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FENOFIBRATEACTIVE INGREDIENTU202363UOSFENOFIBRATE TABLET [CARILION MATERIALS MANAGEMENT]2
FENOFIBRATEACTIVE MOIETYU202363UOSFENOFIBRATE TABLET [CARILION MATERIALS MANAGEMENT]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFENOFIBRATE TABLET [CARILION MATERIALS MANAGEMENT]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKFENOFIBRATE TABLET [CARILION MATERIALS MANAGEMENT]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GFENOFIBRATE TABLET [CARILION MATERIALS MANAGEMENT]2
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0FENOFIBRATE TABLET [CARILION MATERIALS MANAGEMENT]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKFENOFIBRATE TABLET [CARILION MATERIALS MANAGEMENT]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8FENOFIBRATE TABLET [CARILION MATERIALS MANAGEMENT]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFENOFIBRATE TABLET [CARILION MATERIALS MANAGEMENT]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFENOFIBRATE TABLET [CARILION MATERIALS MANAGEMENT]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FENOFIBRATE TABLET [CARILION MATERIALS MANAGEMENT]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990FENOFIBRATE TABLET [CARILION MATERIALS MANAGEMENT]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JFENOFIBRATE TABLET [CARILION MATERIALS MANAGEMENT]2
SUCROSEINACTIVE INGREDIENTC151H8M554FENOFIBRATE TABLET [CARILION MATERIALS MANAGEMENT]2
TALCINACTIVE INGREDIENT7SEV7J4R1UFENOFIBRATE TABLET [CARILION MATERIALS MANAGEMENT]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFENOFIBRATE TABLET [CARILION MATERIALS MANAGEMENT]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEFENOFIBRATE TABLET [CARILION MATERIALS MANAGEMENT]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-4718FENOFIBRATE TABLET [CARILION MATERIALS MANAGEMENT]3Legacy NDC, 1 package rows20160806_ca72a571-1d68-4526-b28a-a3034a1c8c09.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
477562fenofibrate 48 MG Oral TabletPSNca72a571-1d68-4526-b28a-a3034a1c8c093
477562fenofibrate 48 MG Oral TabletSCDca72a571-1d68-4526-b28a-a3034a1c8c093

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68151-4718-9681514718091 in 1 PACKAGEHistorical