Quick answers
- What is Argatroban used for?
- The FDA-approved label (Argatroban, Accord Healthcare Inc., May 21, 2026) says: “Argatroban in Sodium Chloride injection is a direct thrombin inhibitor indicated: For prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT) As an anticoagulant in adult patients with or at risk for HIT undergoing percutaneous coronary intervention (PCI) 1.1 Heparin-Induced Thrombocytopenia Argatroban in Sodium Chloride Injection is indicated for prophylaxis or treatment …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Argatroban have a boxed warning?
- No. None of the 16 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Argatroban?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Argatroban been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Argatroban?
- 12 companies list prescription products of Argatroban in the FDA NDC Directory, including Hikma Pharmaceuticals USA Inc., Gland Pharma Limited and Par Health USA, LLC.
What Argatroban is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Argatroban in Sodium Chloride injection is a direct thrombin inhibitor indicated: For prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT) As an anticoagulant in adult patients with or at risk for HIT undergoing percutaneous coronary intervention (PCI) 1.1 Heparin-Induced Thrombocytopenia Argatroban in Sodium Chloride Injection is indicated for prophylaxis or treatment …
— FDA label: Argatroban, Accord Healthcare Inc., effective May 21, 2026. Read the full label on DailyMed →
The FDA has 16 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 16 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection · Injection, solution · Solution |
|---|---|
| Route | Intravenous |
| Prescription products | 17 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.
- Hikma Pharmaceuticals USA Inc.4 products
- Gland Pharma Limited2 products
- Par Health USA, LLC2 products
- Mullan Pharmaceutical Inc.2 products
- Accord Healthcare Inc.1 product
- Eugia US LLC1 product
- Plano Pharmaceuticals Inc.1 product
- Fresenius Kabi USA, LLC1 product
- Sagent Pharmaceuticals1 product
- Caplin Steriles Limited1 product
- Amneal Pharmaceuticals LLC1 product
- Mylan Institutional LLC1 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 |
|---|---|---|---|
| NDA022485 ARGATROBAN IN SODIUM CHLORIDE | Plano Pharms | May 9, 2011 | 6, latest September 25, 2026 2026: Labeling · 2019: Labeling · 2018: Labeling |
| NDA203049 ARGATROBAN | Hikma Pharm Co Ltd | January 5, 2012 | 6, latest May 15, 2026 2026: Labeling · 2020: Labeling · 2016: Labeling |
| NDA209552 ARGATROBAN IN SODIUM CHLORIDE | Eugia Pharma Speclts | November 27, 2018 | 1, latest June 10, 2026 2026: Labeling |
| NDA212035 ARGATROBAN IN SODIUM CHLORIDE | Accord Hlthcare | June 7, 2021 | 2, latest July 31, 2026 2026: Labeling · 2026: Labeling |
Generic approvals (6)
- ANDA091665Ph Health · June 30, 2014
- ANDA202626Mylan Institutional · June 30, 2014
- ANDA205570Gland · May 22, 2017
- ANDA206698Amneal Pharms Co · January 26, 2018
- ANDA214235Caplin · January 21, 2021
- ANDA217848Gland · July 31, 2023
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 308351, 1804735, 1804737 |
|---|---|
| SPL set ID of the quoted label | 46cdf9e6-839c-49c8-9ee1-c30cfdd9368d |
| FDA labels (SPL) | 16 |
| FDA applications | NDA022485, NDA203049, NDA209552, NDA212035, 6 ANDA |
| Active ingredients (FDA) | ARGATROBAN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Argatroban, Accord Healthcare Inc., effective May 21, 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 →