FDA.reportPublic FDA data

Fenofibric Acid

Product NDC
50090-4561
11-digit product format
500904561
Labeler code
50090
Product ID
50090-4561_a988ac8b-c9ab-4eb8-91b4-735bed59c6e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fenofibric Acid
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
NDA022224
Marketing category
NDA AUTHORIZED GENERIC
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
2022-12-31
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 productproduct50090-4561IInactivated by FDA2026-07-31
excluded packagepackage50090-456150090-4561-0IInactivated by FDA2026-07-31

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FENOFIBRATEEQ 45MG FENOFIBRIC ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, DELAYED RELEASE / ORALRLD2008-12-15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FENOFIBRATEEQ 135MG FENOFIBRIC ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, DELAYED RELEASE / ORALRLD2008-12-15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 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4561-02023-01-30C16284748780-1f386c64a-0e25-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use fenofibric acid delayed release capsules safely and effectively. See full prescribing information for fenofibric acid delayed release capsules. Fenofibric acid capsule, delayed release for oral use Initial U.S. Approval: 2008

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4561-0Fenofibric Acid90 in 1 BOTTLECAPSULE, DELAYED RELEASE904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4561-0EA - Each50090-4561632c3929-77e2-4678-9a50-f180ebfe73fa12022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4561FENOFIBRIC ACID CAPSULE, DELAYED RELEASE [A-S MEDICATION SOLUTIONS]4Legacy NDC, 1 package rows20210417_e3ad559c-b107-409f-a297-a052765b71ab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828373fenofibric acid 135 MG Delayed Release Oral CapsulePSNe3ad559c-b107-409f-a297-a052765b71ab4
828373fenofibric acid 135 MG Delayed Release Oral CapsuleSCDe3ad559c-b107-409f-a297-a052765b71ab4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4561-05009045610090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-4561-0) 2019-09-260000-00-00NoNoCurrent