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Prescription medicine · generic available

Eptifibatide

Drug class: Platelet Aggregation Inhibitor

The FDA’s “Established Pharmacologic Class”: the group of medicines that work in a similar way.

Full FDA label All drugs

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

NoBoxed warning
None listedFDA shortage list
2Recalls (FDA reports)
8Companies
2015First FDA approval on file

Quick answers

What is Eptifibatide used for?
The FDA-approved label (Eptifibatide, Slate Run Pharmaceuticals, LLC, February 9, 2026) says: “Eptifibatide injection is a platelet aggregation inhibitor indicated for: Treatment of acute coronary syndrome (ACS) managed medically or with percutaneous coronary intervention (PCI) Treatment of patients undergoing PCI (including intracoronary stenting) 1.1 Acute Coronary Syndrome (ACS) Eptifibatide injection is indicated to decrease the rate of a combined endpoint of death or new myocardial infarction (MI) in …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Eptifibatide have a boxed warning?
No. None of the 9 FDA labels we found for this medicine has a boxed warning.
Is there a shortage of Eptifibatide?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Eptifibatide been recalled?
FDA enforcement reports list 2 recalls of products of this medicine; the newest started February 12, 2026 (Class III). A recall usually concerns specific lots, not every product.
Who makes Eptifibatide?
8 companies list prescription products of Eptifibatide in the FDA NDC Directory, including Mylan Institutional LLC, Slate Run Pharmaceuticals, LLC and Eugia US LLC.

What Eptifibatide is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

Eptifibatide injection is a platelet aggregation inhibitor indicated for: Treatment of acute coronary syndrome (ACS) managed medically or with percutaneous coronary intervention (PCI) Treatment of patients undergoing PCI (including intracoronary stenting) 1.1 Acute Coronary Syndrome (ACS) Eptifibatide injection is indicated to decrease the rate of a combined endpoint of death or new myocardial infarction (MI) in …

— FDA label: Eptifibatide, Slate Run Pharmaceuticals, LLC, effective February 9, 2026. Read the full label on DailyMed →

The FDA has 9 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.

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 9 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsInjection, solution · Injection
RouteIntravenous
Prescription products21 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.

FDA approval history

  • ANDA: Abbreviated New Drug Application: how a generic version is approved.

Generic approvals (7)

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

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.

  1. February 12, 2026 · Class III · Ongoing · D-0343-2026

    Labeling: Not Elsewhere Classified. The carton for Eptifibatide Injection 75 mg/100 mL states 75 mg/100 mL vial for weight-adjusted bolus dosing. The approved statement is 75 mg/100 mL vial for weight-adjusted infusion.

    Eptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing, 1x100 mL Single-dose Vial, For Intravenous Use Only, Rx Only, Manufactured by: Hainan Poly Pharm. Co., Ltd., Guilinyang Economic Development Are — Slate Run Pharmaceuticals

  2. May 22, 2024 · Class III · Ongoing · D-0556-2024

    Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.

    Eptifibatide injection 20mg/10mL (2mg/mL), 10mL Single-Dose Vial, Rx only, Mfd. In India for: AuroMedics Pharma, LLC, E. Windsor, NJ 08520, NDC 55150-219-10 — Eugia US LLC

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)200349, 1736470, 1736477
SPL set ID of the quoted labelda421d88-6c00-428a-82a6-b3b4f7a68b85
FDA labels (SPL)9
FDA applications7 ANDA
Active ingredients (FDA)EPTIFIBATIDE

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Eptifibatide, Slate Run Pharmaceuticals, LLC, effective February 9, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. 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 →

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