FDA.reportPublic FDA data

Tricor

Product NDC
43353-272
11-digit product format
433530272
Labeler code
43353
Product ID
43353-272_3e47ea73-8fb6-4624-9dad-de04d8d650de
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-272-30Tricor30 in 1 BOTTLETABLET301
43353-272-83Tricor3600 in 1 BOTTLETABLET36001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-272-30EA - Each43353-272c8d85f2f-f0c6-4ffe-ae1a-714970848b0b12017-11-06
43353-272-83EA - Each43353-272a0bba140-5223-4b08-a563-67147b4f6a5b12017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-272TRICOR (FENOFIBRATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 2 package rows20171013_70275d9c-a321-4561-adbf-60b555718ce2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
477560fenofibrate 145 MG Oral TabletPSN70275d9c-a321-4561-adbf-60b555718ce21
540281TriCor 145 MG Oral TabletPSN70275d9c-a321-4561-adbf-60b555718ce21
540281fenofibrate 145 MG Oral Tablet [Tricor]SBD70275d9c-a321-4561-adbf-60b555718ce21
477560fenofibrate 145 MG Oral TabletSCD70275d9c-a321-4561-adbf-60b555718ce21
540281Tricor 145 MG Oral TabletSY70275d9c-a321-4561-adbf-60b555718ce21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43353-272-304335302723030 TABLET in 1 BOTTLE (43353-272-30) 30 tablet2017-01-270000-00-00NoNoCurrent
43353-272-83433530272833600 TABLET in 1 BOTTLE (43353-272-83) 3600 tablet2017-01-270000-00-00NoNoCurrent