What this pack is
TRICOR is the brand name in this record; fenofibrate tablets is the generic name. Read both together with the dosage form (oral tablet).
PACK CHECK · MARKET FIRST
TRICORGeneric namefenofibrate tablets
How this medicine works
The label describes TRICOR as a PPAR-alpha agonist. Fenofibrate is hydrolysed by esterases to active fenofibric acid and affects lipoprotein lipase and triglyceride-rich particle metabolism. This helps explain why it is not a statin, but cannot decide individual need, 48 versus 145 mg, combination or substitution.
Read source: United States ↗reviewed 2026-08-30More about its action and precautions →Check the market, names, dosage form and route together
A medicine may use different brand names across markets. Keep the market, brand, generic name, dosage form and route together; one matching field does not prove that two packs are the same or interchangeable.
Open the complete product-identity record
Use these fields when the pack, market name or package image needs closer checking. They are evidence boundaries, not substitution instructions.
- International brand name
- TRICOR
- Generic name
- fenofibrate tablets
- Dosage-form class
- Fenofibrate oral tablets: 48 mg yellow unscored tablet imprinted FI and 145 mg white unscored tablet imprinted FO; two historical 90-tablet bottles
- Route
- Oral
- Package-image status
- A source-linked public label image is available below
No source-verifiable mainland-China trade-name cue has been established for this record. This does not establish whether the medicine exists, is approved or is available in mainland China. Check pack text and current CDE/NMPA records item by item.
FOR EVERYDAY QUESTIONS
After the leaflet, continue with the question you still need to check
What this page can show
This is a source-traceable public record. It helps you read the product identity and its listed source documents; each market still needs its own current record check.
What to bring to the next conversation
Bring the actual pack, the label or prescription, and a complete medicine list when you speak with a pharmacist or clinician.
NEXT SAFE STEP
Choose the next safe check
A question about changing, combining or splitting?Put the exact packs on one list before a pharmacist or prescriber checks the full context.Open the family medicine list →A question about cost, reimbursement or availability?First lock the market, exact presentation and date. Use local official reimbursement, hospital or pharmacy channels for a current answer rather than a web estimate.Open regulator and market-record entry points →Unsure about a pack or a cross-border product?Photo reading can return possible record matches only. Check the actual product against the current regulator record for its market.Identify pack text locally →Saw a recall, approval or procurement headline?Open the original publisher, then match its product, market and date. Do not make a stop or switch decision from a headline.Read primary-source news →
PRODUCT PRESENTATION IDENTITY
Strength, pack and device identity
Package strength is not an individual dose. These fields help identify the exact labelled product; they do not calculate how much, how often, a missed-use action, splitting, switching or conversion.
How to read a score line: ‘scored’ or ‘unscored’ first identifies this labelled presentation. A score line by itself does not permit self-splitting, reducing or changing the product. Only an explicit statement in the current label for this exact presentation, checked with a pharmacist against the prescription, can support any further handling.
2 source-backed strength, pack or device records — open the full list
First match the market, dosage form and labelled amount on the pack in hand. The number of tablets, sachets or devices in a pack is not a personal dose or schedule.
United States label · Dated U.S. DailyMed brand label (revised Jun 2025); FDA Orange Book currently lists DISCN, not evidence of supply
Fenofibrate 48 mg per tablet; 90-tablet bottle; U.S. brand listing discontinued
- Product code
- NDC 0074-3173-90
- Form and route
- TRICOR fenofibrate oral tablet · oral; label says swallow whole
- Container
- bottle
- Listing review
- Cited product evidence reviewed 2026-08-30; actual marketing, stock and availability are not established.
- fenofibrate
- 48 mglabelled amount per tablet; not an individual tablet count, switching ratio or statin conversion
- Package
- 90 tablets per bottle
- Labelled appearance
- yellow · oval, unscored tablet · imprint FIUnscored; do not infer permission to split it
United States label · Dated U.S. DailyMed brand label (revised Jun 2025); FDA Orange Book currently lists DISCN, not evidence of supply
Fenofibrate 145 mg per tablet; 90-tablet bottle; U.S. brand listing discontinued
- Product code
- NDC 0074-3189-90
- Form and route
- TRICOR fenofibrate oral tablet · oral; label says swallow whole
- Container
- bottle
- Listing review
- Cited product evidence reviewed 2026-08-30; actual marketing, stock and availability are not established.
- fenofibrate
- 145 mglabelled amount per tablet; not an individual tablet count, switching ratio or statin conversion
- Package
- 90 tablets per bottle
- Labelled appearance
- white · oval, unscored tablet · imprint FOUnscored; do not infer permission to split it
PUBLIC LABEL IMAGE
Appearance and package-text clues
This dated or historical public-label image is for checking the brand, generic-name, strength and dosage-form clues only. It does not authenticate a product or establish originator status, a current label, current packaging, target-market approval or sale eligibility.
Open the public label source ↗LABEL READING · NOT A PRESCRIPTION
TRICOR label reading: 48 mg and 145 mg are per-tablet strengths, and historical packs are not current supply
Reading level: drug-specific label reading. This record has been expanded around its dosage form or a higher-risk reading question; the current target-market label and professional review still apply.
Check TRICOR, fenofibrate, exact strength, FI/FO imprint, NDC and market before reading whole-tablet, kidney-function and co-medication warnings. The site never uses arithmetic between 48 and 145 to switch a medicine or calculate tablets.
- 48 mg and 145 mg are labelled fenofibrate amounts per tablet. '90 Tablets' is the bottle count, not 90 tablets per dose, and 145 does not permit self-assembling three 48 mg tablets.
- The 2025 label says swallow whole and not to crush, break, dissolve or chew. Both tablets are unscored. If swallowing is difficult or a strength change is considered, ask the pharmacist or prescriber to review another appropriate product.
- The label bases geriatric dosage selection on kidney function. Age 65 or older, renal impairment, uncontrolled hypothyroidism, and use with a statin or colchicine require priority review of myopathy and rhabdomyolysis risk. Do not self-stop or self-add from the page.
- Coumarin anticoagulants such as warfarin, immunosuppressants, potentially nephrotoxic medicines and bile-acid resins belong on the review list. Unexplained muscle pain/weakness with fever or malaise, dark urine, jaundice, swelling of the face/lips/tongue/throat or breathing trouble requires prompt medical contact; severe acute features require local emergency care.
PHARMACOVIGILANCE · OFFICIAL ROUTES
Check safety information in the right market
Start with the public label or product record linked to this dossier, then use the official safety routes below for the market that applies to the medicine in hand.
Match five details before using a safety record
- Brand and generic nameBoth must match the medicine named by the record.
- Dosage form and strengthTablet, capsule, injection, inhaler, patch and eye drop are not interchangeable.
- Market and notice dateA record applies only to the country or region and date it names.
- Lot, pack and manufacturerRecord these only when the official notice specifically names them.
- Current product informationA historical record may have been superseded by the current label.
This checklist only helps organise the right question. It does not create a personal conclusion about stopping, switching, dose, combination or suitability.
This dossier’s product-level source checkU.S. National Library of Medicine DailyMed · United States · Public medicine label · 2026-08-30
This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk.
Markets actually represented by the reviewed product documents
- United States · 3
This is a document-coverage summary, not a claim that the medicine is authorised, supplied, interchangeable or actively monitored in every listed market today.
This record’s label or product-record routeDailyMed (NLM): U.S. TRICOR 48 mg / 145 mg brand label (AbbVie; revised Jun 2025; two historical package panels) ↗reviewed 2026-08-30
Other official market or version documents for this record
These are separately reviewed product documents for the same dossier. Their market, date, dosage form and document status must stay attached to each link; they do not establish interchangeability between products, strengths, packs, indications or countries.
- FDA · United States · Regulatory product record or label archive · 2026-08-29FDA Orange Book: TRICOR NDA 021656 48 mg / 145 mg both listed as RLD and DISCN (data reviewed 30 Aug 2026) ↗reviewed 2026-08-29
- FDA · United States · Regulatory product record or label archive · 2026-08-30FDA Drugs@FDA: official TRICOR NDA 021656 application search entry ↗Current regulatory record · reviewed 2026-08-30
This is not a conclusion that the medicine has no risk, warning, recall or newer notice in another market. Start with the checked product-level label above, then use the official market gateways below for the product in hand.
See the reviewed safety-record directory →Global official safety gateways
- NMPA Centre for Drug Reevaluation · Mainland ChinaPrimary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item.Drug-vigilance bulletins and safety notices ↗reviewed 2026-08-22
- FDA · United StatesPrimary FDA pages for important new safety issues, labelling changes and risk communications.Drug Safety Communications ↗reviewed 2026-08-22
- FDA MedWatch · United StatesU.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality.Safety information and serious-problem reporting ↗reviewed 2026-08-22
- EMA · European Union / European Economic AreaOfficial EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment.Pharmacovigilance overview and EudraVigilance ↗reviewed 2026-08-22
- MHRA · United KingdomPrimary UK MHRA medicine-safety updates for professionals and the public.Drug Safety Update ↗reviewed 2026-08-22
- PMDA · JapanPMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents.Medicine safety information ↗reviewed 2026-08-22
- MFDS · Republic of KoreaMFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case.Medicine safety letters ↗reviewed 2026-08-22
- HSA · SingaporeHSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information.Adverse-event reporting and medicine-safety information ↗reviewed 2026-08-22
- Health Canada · CanadaHealth Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item.MedEffect Canada: advisories, warnings and recalls ↗reviewed 2026-08-22
- TGA · AustraliaPrimary Australian TGA safety alerts, advisories and monitoring information for therapeutic products.Medicine safety alerts ↗reviewed 2026-08-22
- Swissmedic · SwitzerlandOfficial Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality.Pharmacovigilance and suspected adverse-reaction reporting ↗reviewed 2026-08-22
- Medsafe · New ZealandNew Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information.Medicine safety communications ↗reviewed 2026-08-22
- SAHPRA · South AfricaSAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information.Medicine safety information, alerts and pharmacovigilance ↗reviewed 2026-08-22
- WHO · GlobalWHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market.Medicine and vaccine safety-alert archive ↗reviewed 2026-08-22
- Anvisa · BrazilAnvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item.Pharmacovigilance, alerts and VigiMed ↗reviewed 2026-08-22
This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline.
For severe or rapidly worsening symptoms, suspected overdose, a severe allergic reaction, loss of consciousness or another emergency, use local emergency services. Do not wait for an online alert search or change a medicine from this page.
PRIVATE FAMILY LIST
Bring this record into a local medicine list
Only the brand, generic name, dosage form and route are added, and they stay in this browser. Copy strength, label directions, start/stop history and any concern from the actual pack; this tool does not calculate a dose or decide combination, switching or stopping.
Add to the family medicine list →PACK · LABEL · MEDICINE LIST
Six checks for this medicine pack
Use this card to organise questions about TRICOR (fenofibrate tablets). Keep the exact pack, its current label and the full medicine list together.
Identify the exact product
TRICOR is the brand in this record and fenofibrate tablets is the active-ingredient name. Check both with the dosage form (Fenofibrate oral tablets: 48 mg yellow unscored tablet imprinted FI and 145 mg white unscored tablet imprinted FO; two historical 90-tablet bottles) and the market on the actual pack.
Read the labelled strength in context
mg, mcg, mg/mL or a percentage describes the labelled amount in one tablet, capsule, measured volume, spray or other unit. It is not an answer to how many units a person should take.
Check before splitting or opening
Before splitting, crushing, chewing or opening anything, find an explicit instruction for this exact product in its current label and ask a pharmacist. A score line or a previous pack is not enough by itself.
Put every product on one list
Include prescriptions, over-the-counter products, eye drops, creams, vitamins, minerals, herbs and supplements. A pharmacist or prescriber needs the whole list before any combination, alternation, switch or stop is considered.
Ask a specific pharmacogenetics question
Ask which medicine, which gene and what clinical decision a result could change. A gene–drug association does not mean broad genetic testing is needed for everyone and must not be used to change treatment without professional review.
Know when to seek urgent help
For a suspected overdose, a severe allergic reaction, fainting or difficulty breathing, use the local emergency or poison-information service now. Do not wait for a website reply or alter several medicines to test what caused it.
This card does not calculate a dose, decide whether medicines can be combined, or replace a clinician or pharmacist. Market-specific current labels and the person's full context still need review.
MARKET DOCUMENTS · READ SEPARATELY
Enlarged market leaflets and regulator documents
Each link retains its own market, date, dosage form and document status. These documents support larger-print reading and item-by-item checking; they do not make products, strengths, packs, indications or use between countries or regions interchangeable.
- DailyMed (NLM): U.S. TRICOR 48 mg / 145 mg brand label (AbbVie; revised Jun 2025; two historical package panels) ↗reviewed 2026-08-30
- FDA Orange Book: TRICOR NDA 021656 48 mg / 145 mg both listed as RLD and DISCN (data reviewed 30 Aug 2026) ↗reviewed 2026-08-29
- FDA Drugs@FDA: official TRICOR NDA 021656 application search entry ↗Current regulatory record · reviewed 2026-08-30
HOW IT WORKS · NOT A TREATMENT PLAN
How TRICOR works: fenofibrate becomes fenofibric acid and activates PPAR-alpha-related pathways
- 'Lipid-lowering medicine' is a broad category. TRICOR differs in ingredient and mechanism from LIPITOR, CRESTOR, ZOCOR, VYTORIN and VASCEPA and cannot be self-converted by milligrams, alternated by day or combined.
- The label's PPAR-alpha mechanism cannot replace assessment of lipids, kidney/liver function, thyroid status, the complete medicine list and prior response, and does not prove cardiovascular-event reduction in every population.
- Whole-genome screening is not the site's default answer for choosing fenofibrate or a statin. A decision should be made by the responsible team around the exact product, clinical question, laboratory data and complete medicine list.
SOURCE EVIDENCE REGISTER
Source evidence map
Every public link is labelled with its market, document status and document type. A historical public record is not a current label, and an official lookup entry is not a product-specific record.
- DailyMed (NLM): U.S. TRICOR 48 mg / 145 mg brand label (AbbVie; revised Jun 2025; two historical package panels) ↗reviewed 2026-08-30
- FDA Orange Book: TRICOR NDA 021656 48 mg / 145 mg both listed as RLD and DISCN (data reviewed 30 Aug 2026) ↗reviewed 2026-08-29
- FDA Drugs@FDA: official TRICOR NDA 021656 application search entry ↗Current regulatory record · reviewed 2026-08-30
- FDA: 2019 TRICOR / TRILIPIX supplemental approval letter (NDA 021656/S-029) ↗reviewed 2026-08-30
SOURCE-TRACEABLE ARCHIVE
TRICORfenofibrate tablets
This page links to public primary-source material for TRICOR. The archive is historical or documentary evidence only; it does not by itself establish originator status, product quality, current labelling, availability or sale eligibility.
DOCUMENT TIMELINE
Document timeline
FDA approved 48 mg and 145 mg under NDA 021656
Current Orange Book data retain approval dates, RLD and DISCN status for both products. This traces product history and does not establish current supply.
FDA Orange Book: TRICOR NDA 021656 48 mg / 145 mg both listed as RLD and DISCN (data reviewed 30 Aug 2026) ↗FDA approved a supplemental safety-label change
The supplement letter links TRICOR 48 mg/145 mg and NDA 021656 to a postmarketing safety-label update.
FDA: 2019 TRICOR / TRILIPIX supplemental approval letter (NDA 021656/S-029) ↗Current FDA product status reviewed
FDA Orange Book data list both 48 mg and 145 mg RLD rows as DISCN. This is the site's review date.
FDA Orange Book: TRICOR NDA 021656 48 mg / 145 mg both listed as RLD and DISCN (data reviewed 30 Aug 2026) ↗
MARKET SCOPE
Market-record boundary
United States
Both RLD brand strengths currently listed as DISCNRetains the dated 2025 label, two official historical package panels and current regulatory status; provides no stock or purchasing route.
Mainland China, EU, Japan and other markets
Exact market-product records not establishedNo local trade name, approval, pack, supply, originator/generic relationship or interchangeability is inferred from the U.S. brand, generic name, milligram figures, colours or NDA.
How to read this record
Read each document in its stated market, date and dosage-form context. A historical record is not a current label and does not support individual medical, substitution or purchasing conclusions.
Keep international and mainland China records separate
This page has a U.S. public history/regulatory archive but no mainland China record for this specific product. That does not establish whether the medicine exists, is approved or is available in mainland China. Verify product identity, dosage form, strength, holder and the current label item by item.
RECORD FAQ
Record questions
Can three TRICOR 48 mg tablets be used as 145 mg?
A webpage cannot authorise that. Three 48 mg tablets arithmetically total 144 mg, but product strength, prescription and kidney-related selection cannot be decided by arithmetic or a 1 mg difference. Ask the pharmacist or prescriber to check the exact prescription.
Is TRICOR the same lipid medicine as atorvastatin or rosuvastatin?
No. TRICOR is fenofibrate, described by the label as a PPAR-alpha agonist, while atorvastatin and rosuvastatin are statins. Different mechanisms do not establish self-combination, conversion or alternation, and the label warns of increased myopathy risk with a statin.
Why is an FDA label visible if the record says discontinued?
Regulatory archives retain historical labels and approvals. Current FDA Orange Book data list both strengths as DISCN, so an accessible label does not prove stock, purchasing availability or relaunch.
READ NEXT
Related reading
Evidence status
The listed links are public sources selected for traceability. They must be rechecked against the current target-market record before any use beyond reading and research.