Quick answers
- What is Fenofibric acid (choline fenofibrate) used for?
- The FDA-approved label (Fenofibric acid, Macleods Pharmaceuticals Limited, July 3, 2025) says: “Fenofibric acid delayed-release capsules is 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 (choline fenofibrate) have a boxed warning?
- No. None of the 2 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Fenofibric acid (choline fenofibrate)?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Fenofibric acid (choline fenofibrate) been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Fenofibric acid (choline fenofibrate)?
- 2 companies list prescription products of Fenofibric acid (choline fenofibrate) in the FDA NDC Directory, including Lupin Pharmaceuticals, Inc. and Macleods Pharmaceuticals Limited.
What Fenofibric acid (choline fenofibrate) is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Fenofibric acid delayed-release capsules is 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, Macleods Pharmaceuticals Limited, effective July 3, 2025. Read the full label on DailyMed →
The FDA has 2 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 2 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Capsule, delayed release |
|---|---|
| Route | Oral |
| Prescription products | 4 in the FDA NDC Directory |
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.
- Lupin Pharmaceuticals, Inc.2 products
- Macleods Pharmaceuticals Limited2 products
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (2)
- ANDA200750Chartwell Rx · December 4, 2013
- ANDA207796Macleods Pharms · February 8, 2024
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 | af225492-73b0-49bb-b32f-5399c3c3ec6d |
| FDA labels (SPL) | 2 |
| FDA applications | 2 ANDA |
| Active ingredients (FDA) | CHOLINE FENOFIBRATE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Fenofibric acid, Macleods Pharmaceuticals Limited, effective July 3, 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 →