FDA.reportPublic FDA data

Tricor

Product NDC
43353-032
11-digit product format
433530032
Labeler code
43353
Product ID
43353-032_159645df-cd6b-46a3-842b-2d50c920a8de
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fenofibrate
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
NDA021656
Marketing category
NDA
Marketing start
2004-11-05
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
2017-12-31
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
43353-032-832020-01-31C16284748780-19d75b9d1-22c5-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use TRICOR safely and effectively. See full prescribing information for TRICOR. TRICOR (fenofibrate) Tablet for oral use Initial U.S. Approval: 1993
43353-032-982020-01-31C16284748780-19d75b9d1-22c5-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use TRICOR safely and effectively. See full prescribing information for TRICOR. TRICOR (fenofibrate) Tablet for oral use Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-032-83Tricor3600 in 1 BOTTLE, PLASTICTABLET36002
43353-032-98Tricor540 in 1 BOTTLE, PLASTICTABLET5402

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-032-83EA - Each43353-032ab11900c-ffd2-4b62-853b-7f43ffbd8f5d12015-01-05
43353-032-98EA - Each43353-032d885abcf-0e1d-474e-8a60-45e3dd10df8312013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FENOFIBRATEACTIVE INGREDIENTU202363UOSTRICOR (FENOFIBRATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
FENOFIBRATEACTIVE MOIETYU202363UOSTRICOR (FENOFIBRATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRICOR (FENOFIBRATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKTRICOR (FENOFIBRATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0TRICOR (FENOFIBRATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82TRICOR (FENOFIBRATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTRICOR (FENOFIBRATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62TRICOR (FENOFIBRATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRICOR (FENOFIBRATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990TRICOR (FENOFIBRATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JTRICOR (FENOFIBRATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
SUCROSEINACTIVE INGREDIENTC151H8M554TRICOR (FENOFIBRATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
TALCINACTIVE INGREDIENT7SEV7J4R1UTRICOR (FENOFIBRATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRICOR (FENOFIBRATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEETRICOR (FENOFIBRATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-032TRICOR (FENOFIBRATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Legacy NDC, 2 package rows20140611_ddb63851-e9b9-4ab0-8e6d-6f83d79741e5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
477560fenofibrate 145 MG Oral TabletPSNddb63851-e9b9-4ab0-8e6d-6f83d79741e52
540281TriCor 145 MG Oral TabletPSNddb63851-e9b9-4ab0-8e6d-6f83d79741e52
540281fenofibrate 145 MG Oral Tablet [Tricor]SBDddb63851-e9b9-4ab0-8e6d-6f83d79741e52
477560fenofibrate 145 MG Oral TabletSCDddb63851-e9b9-4ab0-8e6d-6f83d79741e52
540281Tricor 145 MG Oral TabletSYddb63851-e9b9-4ab0-8e6d-6f83d79741e52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
43353-032-83433530032833600 in 1 BOTTLE, PLASTICHistorical
43353-032-9843353003298540 in 1 BOTTLE, PLASTICHistorical