Prescription medicine
Eptifibatide First approved as Integrilin
Eptifibatide (Integrilin) is a prescription medicine with an FDA approval on record since 1998. FDA's NDC Directory lists it from 8 generic labelers.
- Generic listed
Check it at the source: the eptifibatide FDA label on DailyMed (effective May 28, 2021, Mylan Institutional LLC); the NDA 20718 record on Drugs@FDA; every eptifibatide label on DailyMed.
Highlights of the record
FDA label of May 28, 2021; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageEptifibatide injection is a platelet aggregation inhibitor indicated for:
Treatment of acute coronary syndrome (ACS) managed medically or with percutaneous coronary intervention (PCI) ( 1.1 )
Treatment of patients undergoing PCI (including intracoronary stenting) ( 1.2 ) 1.1 Acute Coronary Syndrome (ACS) Eptifibatide injection is indicated to decrease the rate of a combined endpoint of death or new myocardial inf
Forms and strengths
- 0.75 mg/ml
- 2 mg/ml
- 20 mg/10ml
- 75 mg/100ml
- 200 mg/100ml
Injection (solution); injection.
On the market
- Earliest approval on file
- May 18, 1998 Integrilin, Msd Sub Merck; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 14 first June 5, 2015; 8 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 8 of which 8 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 3 since 2016 0 Class I among all firms' recalls; latest February 12, 2026; 3 more by firms not listed as its makers
- FAERS reports
- 766 through July 30, 2026
What is eptifibatide used for?
From the label: indications and usageEptifibatide injection is a platelet aggregation inhibitor indicated for:
Treatment of acute coronary syndrome (ACS) managed medically or with percutaneous coronary intervention (PCI) ( 1.1 )
Treatment of patients undergoing PCI (including intracoronary stenting) ( 1.2 ) 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 patients with ACS (unstable angina [UA]/non-ST- elevation myocardial infarction [NSTEMI]), including patients who are to be managed medically and those undergoing percutaneous coronary intervention (PCI). 1.2 Percutaneous Coronary Intervention (PCI) Eptifibatide injection is indicated to decrease the rate of a combined endpoint of death, new MI, or need for urgent intervention in patients undergoing PCI, including those undergoing intracoronary stenting [see Clinical Studies (14.1 , 14.2) ]. […]
Conditions named in the indications of eptifibatide's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Platelet Aggregation Inhibitor.
Source: FDA drug label (Eptifibatide), Mylan Institutional LLC, effective May 28, 2021 (SPL set 88a37f9c-496b-4a6b-9665-4550abba04f1), via openFDA; the full label on DailyMed
Is there a generic for eptifibatide (Integrilin)?
The FDA approved the first generic eptifibatide on June 5, 2015. 14 generic applications are approved; 8 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists eptifibatide from 8 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1998 earliest approval on file
- 2015 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has eptifibatide been recalled?
The FDA's Enforcement Report lists 6 recalls naming eptifibatide since 2016: 0 Class I (the most serious), 1 Class II, 5 Class III; 2 still ongoing. 3 of them are by firms that FDA's NDC Directory does not list as a maker of eptifibatide and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| February 12, 2026 | Class III | Slate Run Pharmaceuticals | Labeling: Not Elsewhere Classified. The carton for Eptifibatide Injection 75 mg/100 mL states 75 mg/100 mL vial for weight-adjusted bolus dosing. … |
| May 22, 2024 | Class III | Eugia US LLC | Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer. |
| August 6, 2019 | Class III | Akorn, Inc. not a listed maker | Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid. |
| August 6, 2019 | Class III | Akorn, Inc. not a listed maker | Short Fill: fill volume was out of specification at 94 mL (specification: no less than 100 mL) and Failed Impurities/Degradation Specifications: Out of … |
| June 17, 2016 | Class II | Teva North America | CGMP Deviations |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the eptifibatide label say about other medicines?
The eptifibatide label names 2 other medicines in its interaction, contraindication or warning sections. The labels of 2 other medicines name eptifibatide. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Aspirin | drug interactions | Coadministration of antiplatelet agents, thrombolytics, heparin, aspirin, and chronic NSAID use increases the risk of bleeding. |
| Heparin | drug interactions | Coadministration of antiplatelet agents, thrombolytics, heparin, aspirin, and chronic NSAID use increases the risk of bleeding. |
Source: FDA drug label (Eptifibatide), Mylan Institutional LLC, effective May 28, 2021 (SPL set 88a37f9c-496b-4a6b-9665-4550abba04f1), via openFDA; the full label on DailyMed
What do FAERS reports show for eptifibatide?
The FDA Adverse Event Reporting System holds 766 reports that list eptifibatide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 131 are coded as a death and 290 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as eptifibatide?
2 other medicines are given the same way (intravenous) and in the same FDA class as eptifibatide or labeled mainly for the same use (heart attack and coronary artery disease), the same class first. Heart attack and coronary artery disease lists all 38 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does eptifibatide compare with medicines for the same use?
1 side-by-side page set eptifibatide beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Other platelet aggregation inhibitors
- the pharmacologic class, with prices and generics
- Eptifibatide side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other