FDA.reportPublic FDA data

Trilipix

Product NDC
0074-3162
11-digit product format
000743162
Labeler code
0074
Product ID
0074-3162_45d3b5e3-12f2-486c-87b6-d2e529e5017c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fenofibric Acid
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
AbbVie Inc.
Application
NDA022224
Marketing category
NDA
Marketing start
2016-09-12
Marketing end
0000-00-00
Substance
FENOFIBRIC ACID
Active strength
135 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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0074-3162DDiscontinued by firm2026-07-31
excluded packagepackage0074-31620074-3162-90DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022224-001TRILIPIXCHOLINE FENOFIBRATEEQ 45MG FENOFIBRIC ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, DELAYED RELEASE / ORALRLD2008-12-15
N022224-002TRILIPIXCHOLINE FENOFIBRATEEQ 135MG FENOFIBRIC ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, DELAYED RELEASE / ORALRLD2008-12-15

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N022224-001TRILIPIXEQ 45MG FENOFIBRIC ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, DELAYED RELEASE / ORALRLD2008-12-15a50c72e98297…
2026-08-01 22:54:322026-06N022224-002TRILIPIXEQ 135MG FENOFIBRIC ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, DELAYED RELEASE / ORALRLD2008-12-15a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0074-3162-90EA - Each0074-31623ba9dda6-9b82-4a7f-b050-c25025f2e38512017-03-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FENOFIBRIC ACIDACTIVE INGREDIENTBGF9MN2HU1TRILIPIX (FENOFIBRIC ACID) CAPSULE, DELAYED RELEASE [ABBVIE INC.]1459
FENOFIBRIC ACIDACTIVE MOIETYBGF9MN2HU1TRILIPIX (FENOFIBRIC ACID) CAPSULE, DELAYED RELEASE [ABBVIE INC.]1459
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKTRILIPIX (FENOFIBRIC ACID) CAPSULE, DELAYED RELEASE [ABBVIE INC.]1459
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675TRILIPIX (FENOFIBRIC ACID) CAPSULE, DELAYED RELEASE [ABBVIE INC.]1459
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTRILIPIX (FENOFIBRIC ACID) CAPSULE, DELAYED RELEASE [ABBVIE INC.]1459
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TRILIPIX (FENOFIBRIC ACID) CAPSULE, DELAYED RELEASE [ABBVIE INC.]1459
GELATININACTIVE INGREDIENT2G86QN327LTRILIPIX (FENOFIBRIC ACID) CAPSULE, DELAYED RELEASE [ABBVIE INC.]1459
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PTRILIPIX (FENOFIBRIC ACID) CAPSULE, DELAYED RELEASE [ABBVIE INC.]1459
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTRILIPIX (FENOFIBRIC ACID) CAPSULE, DELAYED RELEASE [ABBVIE INC.]1459
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JTRILIPIX (FENOFIBRIC ACID) CAPSULE, DELAYED RELEASE [ABBVIE INC.]1459
POVIDONESINACTIVE INGREDIENTFZ989GH94ETRILIPIX (FENOFIBRIC ACID) CAPSULE, DELAYED RELEASE [ABBVIE INC.]1459
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TRILIPIX (FENOFIBRIC ACID) CAPSULE, DELAYED RELEASE [ABBVIE INC.]1459
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UITRILIPIX (FENOFIBRIC ACID) CAPSULE, DELAYED RELEASE [ABBVIE INC.]1459
TALCINACTIVE INGREDIENT7SEV7J4R1UTRILIPIX (FENOFIBRIC ACID) CAPSULE, DELAYED RELEASE [ABBVIE INC.]1459
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRILIPIX (FENOFIBRIC ACID) CAPSULE, DELAYED RELEASE [ABBVIE INC.]1459
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMTRILIPIX (FENOFIBRIC ACID) CAPSULE, DELAYED RELEASE [ABBVIE INC.]1459
WATERINACTIVE INGREDIENT059QF0KO0RTRILIPIX (FENOFIBRIC ACID) CAPSULE, DELAYED RELEASE [ABBVIE INC.]1459

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0074-3162-900007431629090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0074-3162-90) 2016-09-120000-00-00NoNoCurrent