Quick answers
- What is Bempedoic acid and ezetimibe used for?
- The FDA-approved label (Nexlizet, Esperion Therapeutics, Inc., June 25, 2026) says: “NEXLIZET, a combination of bempedoic acid and ezetimibe, is indicated: as an adjunct to diet and exercise to reduce LDL-C in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). Bempedoic acid, a component of NEXLIZET, is indicated …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Bempedoic acid and ezetimibe have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Bempedoic acid and ezetimibe?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Bempedoic acid and ezetimibe been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started March 27, 2024 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Bempedoic acid and ezetimibe?
- 1 company lists prescription products of Bempedoic acid and ezetimibe in the FDA NDC Directory, including Esperion Therapeutics, Inc..
What Bempedoic acid and ezetimibe is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
NEXLIZET, a combination of bempedoic acid and ezetimibe, is indicated: as an adjunct to diet and exercise to reduce LDL-C in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). Bempedoic acid, a component of NEXLIZET, is indicated …
— FDA label: Nexlizet, Esperion Therapeutics, Inc., effective June 25, 2026. Read the full label on DailyMed →
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.
Forms and how it is given
| Dosage forms | Tablet, film coated |
|---|---|
| Route | Oral |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Nexlizet |
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 |
|---|---|---|
| bempedoic acid 180 mg · ezetimibe 10 mg tablet, film coated | Brand: Nexlizet | $13.81 per tablet |
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.
- Esperion Therapeutics, Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA211617 NEXLIZET | Esperion Theraps Inc | February 26, 2020 | 8, latest January 9, 2026 2026: Labeling · 2025: Efficacy · 2025: Labeling |
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.
-
March 27, 2024 · Class III · Completed · D-0441-2024
Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint.
NEXLIZET (bempedoic acid and ezetimibe) tablets, 180 mg/10 mg, 30-count bottle, Rx only, Manufactured for: Esperion Therapeutics, Ann Arbor, MI 48108, NDC 72426-818-03 — Esperion
-
August 16, 2023 · Class III · Terminated · D-1143-2023
Failed dissolution specifications: below specification results at stability 12-month
Nexlizet (bempedoic acid and ezetimibe), 180ng/18mg, 30 tablets, Rx only, Manufactured for: Esperion Therapeutics, Inc, Ann Arbor, MI 48108, NDC 72426-818-03 — Esperion
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
| RxCUI (RxNorm) | 2283230, 2283236 |
|---|---|
| SPL set ID of the quoted label | 3fa2108c-0300-47b8-9d34-f762af7c93c6 |
| FDA labels (SPL) | 1 |
| FDA applications | NDA211617 |
| Active ingredients (FDA) | BEMPEDOIC ACID / EZETIMIBE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Nexlizet, Esperion Therapeutics, Inc., effective June 25, 2026; 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 →