Quick answers
- What is Fenofibric acid used for?
- The FDA-approved label (Fenofibric Acid, Leading Pharma, LLC, August 22, 2025) says: “Fenofibric acid delayed-release capsules are indicated as adjunctive therapy to diet: to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL). to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia when use of recommended LDL-C lowering therapy is not possible. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Fenofibric acid have a boxed warning?
- No. None of the 4 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Fenofibric acid?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Fenofibric acid been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Fenofibric acid?
- 5 companies list prescription products of Fenofibric acid in the FDA NDC Directory, including Aurobindo Pharma Limited, Alembic Pharmaceuticals Inc. and Amneal Pharmaceuticals of New York LLC.
What Fenofibric acid is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Fenofibric acid delayed-release capsules are indicated as adjunctive therapy to diet: to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL). to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia when use of recommended LDL-C lowering therapy is not possible. …
— FDA label: Fenofibric Acid, Leading Pharma, LLC, effective August 22, 2025. Read the full label on DailyMed →
The FDA has 4 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 4 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Capsule, delayed release |
|---|---|
| Route | Oral |
| Prescription products | 10 in the FDA NDC Directory |
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 |
|---|---|---|
| fenofibric acid 135 mg capsule, delayed release | Generic | $0.2548 per capsule |
| fenofibric acid 45 mg capsule, delayed release | Generic | $0.1683 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.
- Aurobindo Pharma Limited2 products
- Alembic Pharmaceuticals Inc.2 products
- Amneal Pharmaceuticals of New York LLC2 products
- Leading Pharma, LLC2 products
- Alembic Pharmaceuticals Limited2 products
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (4)
- ANDA200264Impax Labs Inc · September 7, 2016
- ANDA208705Alembic · May 12, 2017
- ANDA211626Rising · July 18, 2019
- ANDA212598Aurobindo Pharma Ltd · July 25, 2019
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 828373, 828379 |
|---|---|
| SPL set ID of the quoted label | daa488be-f580-430c-a72c-80ac31bb3e40 |
| FDA labels (SPL) | 4 |
| FDA applications | 4 ANDA |
| Active ingredients (FDA) | FENOFIBRIC ACID |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Fenofibric Acid, Leading Pharma, LLC, effective August 22, 2025; 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 →