FDA.reportPublic FDA data

Tricor

Product NDC
0074-3189
11-digit product format
000743189
Labeler code
0074
Product ID
0074-3189_7d6fd4ec-c931-458a-8687-fd3a96dfda2c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fenofibrate
Dosage form
TABLET
Route
ORAL
Labeler
AbbVie Inc.
Application
NDA021656
Marketing category
NDA
Marketing start
2016-02-05
Marketing end
0000-00-00
Substance
FENOFIBRATE
Active strength
145 mg/1
Pharmacologic classes
Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FENOFIBRATEACTIVE INGREDIENTU202363UOSTRICOR (FENOFIBRATE) TABLET [ABBVIE INC.]1426
FENOFIBRATEACTIVE MOIETYU202363UOSTRICOR (FENOFIBRATE) TABLET [ABBVIE INC.]1426
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRICOR (FENOFIBRATE) TABLET [ABBVIE INC.]1426
CROSPOVIDONEINACTIVE INGREDIENT68401960MKTRICOR (FENOFIBRATE) TABLET [ABBVIE INC.]1426
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTRICOR (FENOFIBRATE) TABLET [ABBVIE INC.]1426
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0TRICOR (FENOFIBRATE) TABLET [ABBVIE INC.]1426
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKTRICOR (FENOFIBRATE) TABLET [ABBVIE INC.]1426
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8TRICOR (FENOFIBRATE) TABLET [ABBVIE INC.]1426
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82TRICOR (FENOFIBRATE) TABLET [ABBVIE INC.]1426
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTRICOR (FENOFIBRATE) TABLET [ABBVIE INC.]1426
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62TRICOR (FENOFIBRATE) TABLET [ABBVIE INC.]1426
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRICOR (FENOFIBRATE) TABLET [ABBVIE INC.]1426
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990TRICOR (FENOFIBRATE) TABLET [ABBVIE INC.]1426
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JTRICOR (FENOFIBRATE) TABLET [ABBVIE INC.]1426
SUCROSEINACTIVE INGREDIENTC151H8M554TRICOR (FENOFIBRATE) TABLET [ABBVIE INC.]1426
TALCINACTIVE INGREDIENT7SEV7J4R1UTRICOR (FENOFIBRATE) TABLET [ABBVIE INC.]1426
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRICOR (FENOFIBRATE) TABLET [ABBVIE INC.]1426
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEETRICOR (FENOFIBRATE) TABLET [ABBVIE INC.]1426

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0074-3189TRICOR (FENOFIBRATE) TABLET [ABBVIE INC.]1516Legacy NDC20241122_b693e68d-f812-4993-54b6-852e3517c344.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
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
0074-3189-900007431899090 TABLET in 1 BOTTLE (0074-3189-90) 90 tablet2016-02-050000-00-00NoNoCurrent