FDA.reportPublic FDA data

Tricor

Product NDC
50090-2899
11-digit product format
500902899
Labeler code
50090
Product ID
50090-2899_98057eb6-358a-493e-8c1d-8a8faeff851b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fenofibrate
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
NDA021656
Marketing category
NDA
Marketing start
2016-02-05
Substance
FENOFIBRATE
Active strength
145 mg/1
Pharmacologic classes
Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tricor
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FENOFIBRATE145 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU202363UOS
Rxcui477560, 540281

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
50090-2899-22023-02-06C16284748780-1f386c649-b44d-0266-e053-dadaa90a7c1aThese 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
50090-2899-22023-01-30C16284748780-1f386c649-b44d-0266-e053-dadaa90a7c1aThese 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
50090-2899-2Tricor90 in 1 BOTTLETABLET9011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2899-2EA - Each50090-28993db14ebb-b5d5-43ec-9640-6e4c4b95166c12019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2899TRICOR (FENOFIBRATE) TABLET [A-S MEDICATION SOLUTIONS]11Current NDC, Legacy NDC, 1 package rows20240501_84b2af1b-365e-4723-ac5f-bc826ec47772.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
477560fenofibrate 145 MG Oral TabletPSN84b2af1b-365e-4723-ac5f-bc826ec4777211
540281TriCor 145 MG Oral TabletPSN84b2af1b-365e-4723-ac5f-bc826ec4777211
540281fenofibrate 145 MG Oral Tablet [Tricor]SBD84b2af1b-365e-4723-ac5f-bc826ec4777211
477560fenofibrate 145 MG Oral TabletSCD84b2af1b-365e-4723-ac5f-bc826ec4777211
540281Tricor 145 MG Oral TabletSY84b2af1b-365e-4723-ac5f-bc826ec4777211

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-2899-25009028990290 TABLET in 1 BOTTLE (50090-2899-2) 90 tablet2017-03-030000-00-00NoNoCurrent