Quick answers
- What is Fenofibrate used for?
- The FDA-approved label (Tricor, A-S Medication Solutions, April 29, 2024) says: “TRICOR is a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet: To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia. For treatment of adult patients with severe hypertriglyceridemia. Limitations of Use …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Fenofibrate have a boxed warning?
- No. None of the 132 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Fenofibrate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Fenofibrate been recalled?
- FDA enforcement reports list 4 recalls of products of this medicine; the newest started May 28, 2026 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Fenofibrate?
- 50 companies list prescription products of Fenofibrate in the FDA NDC Directory, including A-S Medication Solutions, Bryant Ranch Prepack and Alembic Pharmaceuticals Inc..
What Fenofibrate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
TRICOR is a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet: To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia. For treatment of adult patients with severe hypertriglyceridemia. Limitations of Use …
— FDA label: Tricor, A-S Medication Solutions, effective April 29, 2024. Read the full label on DailyMed →
The FDA has 132 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 132 FDA labels for this medicine have a boxed warning.
Forms and how it is given
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| fenofibrate 120 mg tablet | Generic | $16.29 per tablet |
| fenofibrate 130 mg capsule | Generic | $0.7205 per capsule |
| fenofibrate 134 mg capsule | Generic | $0.1214 per capsule |
| fenofibrate 145 mg tablet | Generic | $0.1191 per tablet |
| fenofibrate 145 mg tablet, coated | Generic | $0.1191 per tablet |
| fenofibrate 145 mg tablet, film coated | Generic | $0.1191 per tablet |
| fenofibrate 150 mg capsule | Generic | $5.32 per capsule |
| fenofibrate 160 mg tablet | Generic | $0.0925 per tablet |
| fenofibrate 160 mg tablet, film coated | Generic | $0.0925 per tablet |
| fenofibrate 200 mg capsule | Generic | $0.1712 per capsule |
| fenofibrate 40 mg tablet | Generic | $5.55 per tablet |
| fenofibrate 43 mg capsule | Generic | $0.3953 per capsule |
| fenofibrate 48 mg tablet | Generic | $0.0799 per tablet |
| fenofibrate 48 mg tablet, coated | Generic | $0.0799 per tablet |
| fenofibrate 48 mg tablet, film coated | Generic | $0.0799 per tablet |
| fenofibrate 50 mg capsule | Generic | $2.56 per capsule |
| fenofibrate 54 mg tablet | Generic | $0.0731 per tablet |
| fenofibrate 54 mg tablet, film coated | Generic | $0.0731 per tablet |
| fenofibrate 67 mg capsule | Generic | $0.0934 per capsule |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- A-S Medication Solutions22 products
- Bryant Ranch Prepack17 products
- Alembic Pharmaceuticals Inc.11 products
- Lupin Pharmaceuticals, Inc.10 products
- Alembic Pharmaceuticals Limited9 products
- Bostal LLC7 products
- ANI Pharmaceuticals, Inc.7 products
- Aurobindo Pharma Limited7 products
- Northwind Health Company, LLC6 products
- Chartwell RX, LLC5 products
- Cipla USA Inc.5 products
- Ajanta Pharma USA Inc.5 products
- American Health Packaging5 products
- NuCare Pharmaceuticals, Inc.5 products
- Remedyrepack Inc.5 products
- AvKARE4 products
- Laurus Labs Limited4 products
- Preferred Pharmaceuticals Inc.4 products
- Leading Pharma, LLC4 products
- Mylan Pharmaceuticals Inc.4 products
- Macleods Pharmaceuticals Limited4 products
- Amneal Pharmaceuticals NY LLC4 products
- Major Pharmaceuticals3 products
- Torrent Pharmaceuticals Limited3 products
- Glenmark Pharmaceuticals Inc., USA3 products
- Golden State Medical Supply, Inc.3 products
- Proficient Rx LP3 products
- AvPAK3 products
- Trifluent Pharma, LLC2 products
- Creekwood Pharmaceuticals LLC2 products
- Safecor Health LLC2 products
- Dr. Reddy's Laboratories Limited2 products
- Amneal Pharmaceuticals LLC2 products
- Lifestar Pharma LLC2 products
- PD-Rx Pharmaceuticals, Inc.2 products
- Amneal Pharmaceuticals of New York LLC2 products
- NorthStar RxLLC2 products
- Camber Pharmaceuticals, Inc.2 products
- Apotex Corp.2 products
- Solco Healthcare US, LLC2 products
- Rhodes Pharmaceuticals LLC2 products
- Dr. Reddy's Laboratories Inc.2 products
- Mylan Institutional Inc.2 products
- Coupler LLC1 product
- NCS HealthCare of KY, Inc dba Vangard Labs1 product
- NCS HealthCare of KY, LLC dba Vangard Labs1 product
- Quallent Pharmaceuticals Health LLC1 product
- St. Mary's Medical Park Pharmacy1 product
- Quality Care Products, LLC1 product
- Westminster Pharmaceuticals, LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021612 LIPOFEN | Cipher Pharms Inc | January 11, 2006 | 12, latest June 6, 2025 2025: Labeling · 2021: Labeling · 2019: Labeling |
| NDA021656 TRICOR | Abbvie | November 5, 2004 | 14, latest June 6, 2025 2025: Labeling · 2021: Labeling · 2021: Labeling |
| NDA021695 ANTARA (MICRONIZED) | Lupin | November 30, 2004 | 17, latest October 1, 2025 2025: Labeling · 2024: Labeling · 2021: Labeling |
Generic approvals (39)
- ANDA076433Rhodes Pharms · May 13, 2005
- ANDA076509Impax Labs · March 26, 2008
- ANDA090856Lupin Ltd · December 23, 2011
- ANDA090859Chartwell Rx · March 1, 2012
- ANDA202856Mylan Pharms Inc · December 7, 2012
- ANDA202252Apotex · July 26, 2013
- ANDA201748Sun Pharm Inds Ltd · October 31, 2014
- ANDA204019Lupin · August 17, 2015
- ANDA205118Aurobindo Pharma · May 5, 2016
- ANDA204475Mylan Pharms Inc · June 23, 2016
- ANDA204598Hetero Labs Ltd III · July 12, 2016
- ANDA208709Cipla · December 15, 2016
- ANDA207378Invagen Pharms · March 28, 2017
- ANDA205566Glenmark Pharms Ltd · April 7, 2017
- ANDA200884Sun Pharm · September 7, 2017
- ANDA207805Reyoung · November 16, 2017
- ANDA207803Bostal · December 19, 2017
- ANDA209951Amneal · February 9, 2018
- ANDA209950Amneal · March 19, 2018
- ANDA209504Ani Pharms · April 30, 2018
- ANDA210782Torrent · June 26, 2018
- ANDA210138Ajanta Pharma Ltd · July 20, 2018
- ANDA210606Rising · August 17, 2018
- ANDA211080Prinston Inc · August 28, 2018
- ANDA210705Ajanta Pharma Ltd · September 10, 2018
- ANDA209660Chartwell Rx · February 11, 2019
- ANDA210476Alembic · August 9, 2019
- ANDA210670DR Reddys · September 6, 2019
- ANDA213252Alembic · January 17, 2020
- ANDA211122Rising · March 18, 2020
- ANDA213864Mankind Pharma · June 12, 2020
- ANDA213842Alembic · October 19, 2020
- ANDA208476Bostal · February 10, 2021
- ANDA212232Aurobindo Pharma Ltd · September 20, 2021
- ANDA216798Aurobindo Pharma · September 27, 2022
- ANDA217732Creekwood Pharms · September 7, 2023
- ANDA211407Chartwell · January 31, 2024
- ANDA210248Macleods Pharms · November 13, 2024
- ANDA210379Macleods Pharms · January 21, 2026
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
May 28, 2026 · Class II · Ongoing · D-0611-2026
CGMP Deviations
Fenofibrate Capsules, USP 200 mg, Rx only, 100 Capsules, Manufactured by: Ajanta Pharma Limited, India, Marketed by: Ajanta Pharma USA Inc. Bridgewater, NJ 08807, NDC 27241-120-04. — Ajanta Pharma USA Inc
-
March 13, 2025 · Class II · Ongoing · D-0314-2025
CGMP Deviations
Fenofibrate Capsules 67 mg, USP, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 0743 — Glenmark Pharmaceuticals Inc., USA
-
March 15, 2021 · Class II · Terminated · D-0407-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
FENOFIBRATE CAPSULES, UPS 67MG 100 CAPSULES NDC/UPC 27241-118-04; RX; CAPSULES — Cardinal Health Inc.
-
September 12, 2018 · Class III · Terminated · D-1211-2018
Presence of Foreign Tablet/Capsule: A foreign identified as Valacyclovir tablet 500 mg was co-mingled in a bottle containing Fenofibrate Tablets, USP 145 mg.
Fenofibrate Tablets, USP 145 mg, 90-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ, 08854, NDC 31722-596-90 — Hetero Labs, Ltd. - Unit III
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Tricor, A-S Medication Solutions, effective April 29, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →