Quick answers
- What is Tirofiban used for?
- The FDA-approved label (Aggrastat, Medicure International Inc, January 1, 2025) says: “AGGRASTAT® is indicated to reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non-ST elevation acute coronary syndrome (NSTE-ACS). …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Tirofiban have a boxed warning?
- No. None of the 6 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Tirofiban?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Tirofiban been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started April 21, 2025 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Tirofiban?
- 5 companies list prescription products of Tirofiban in the FDA NDC Directory, including Medicure International Inc, Eugia US LLC and Nexus Pharmaceuticals LLC.
What Tirofiban is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
AGGRASTAT® is indicated to reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non-ST elevation acute coronary syndrome (NSTE-ACS). …
— FDA label: Aggrastat, Medicure International Inc, effective January 1, 2025. Read the full label on DailyMed →
The FDA has 6 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 6 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution · Injection |
|---|---|
| Route | Intravenous |
| Prescription products | 10 in the FDA NDC Directory |
| Brand names | Aggrastat |
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.
- Medicure International Inc4 products
- Eugia US LLC2 products
- Nexus Pharmaceuticals LLC2 products
- Gland Pharma Limited1 product
- Sagent Pharmaceuticals1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA020912 AGGRASTAT | Medicure | May 14, 1998 | 18, latest May 16, 2019 2019: Labeling · 2016: Manufacturing (CMC) · 2015: Labeling |
| NDA020913 AGGRASTAT | Medicure | May 14, 1998 | 16, latest December 11, 2020 2020: Manufacturing (CMC) · 2019: Labeling · 2016: Manufacturing (CMC) |
Generic approvals (3)
- ANDA206888Gland · April 8, 2021
- ANDA213947Nexus · February 7, 2023
- ANDA216379Eugia Pharma · May 1, 2023
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.
-
April 21, 2025 · Class II · Ongoing · D-0390-2025
Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Tirofiban Hydrochloride Injection 12.5 mg/250 mL (50 mcg/mL), 250 mL single-dose container (bag), Rx only, Manufactured in India for: Eugia U.S. LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520, NDC 55150-430-01 — Eugia US LLC
-
April 21, 2025 · Class II · Ongoing · D-0389-2025
Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Tirofiban Hydrochloride Injection 5 mg/100 mL (50 mcg/mL), 100 mL single-dose container (bag), Rx only, Manufactured in India for: Eugia U.S. LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520, NDC 55150-429-01 — 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
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Aggrastat, Medicure International Inc, effective January 1, 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 →