Esperion Therapeutics, Inc.
NDC labeler code: 72426
What is a labeler?
The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.
Official FDA data only
Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.
Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.
Prescription medicines
- Bempedoic acid and ezetimibeNexlizet · 1 product
- Bempedoic acidNexletol · 1 product
FDA applications for these products
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| February 26, 2020 | NDA211617 | Bempedoic acid and ezetimibe NEXLIZET | Esperion Theraps Inc |
| February 21, 2020 | NDA211616 | Bempedoic acid NEXLETOL | Esperion Theraps Inc |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2024
-
March 27, 2024 · Class III · Completed · D-0441-2024 · Bempedoic acid and ezetimibe
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
2023
-
August 16, 2023 · Class III · Terminated · D-1143-2023 · Bempedoic acid and ezetimibe
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
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).
Sources
- 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