Prescription medicine
Argatroban
Argatroban is a prescription medicine with an FDA approval on record since 2000. FDA's NDC Directory lists it from 8 generic labelers.
- Generic listed
Check it at the source: the argatroban FDA label on DailyMed (effective May 3, 2026, Hikma Pharmaceuticals USA Inc.); the NDA 20883 record on Drugs@FDA; every argatroban label on DailyMed.
Highlights of the record
FDA label of May 3, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageArgatroban is a direct thrombin inhibitor indicated: For prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT) ( 1.1 ) As an anticoagulant in adult patients with or at risk for HIT undergoing percutaneous coronary intervention (PCI) ( 1.2 ) 1.1 Heparin-Induced Thrombocytopenia Argatroban Injection is indicated for prophylaxis or treatment of thrombosis in adult patients
Forms and strengths
- 1 mg/ml
- 50 mg/50ml
- 100 mg/ml
- 125 mg/125ml
- 250 mg/2.5ml
Injection; injection (solution); solution.
On the market
- Earliest approval on file
- June 30, 2000 Argatroban, Sandoz; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 7 first June 30, 2014; 7 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 12 of which 8 under generic applications, 4 under brand applications, repackagers included
- Last listed patent
- September 26, 2027 Argatroban In Sodium Chloride injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2011 1 Class I among all firms' recalls; latest July 6, 2017; 2 more by firms not listed as its makers
- FAERS reports
- 1,496 through July 30, 2026
What is argatroban used for?
From the label: indications and usageArgatroban is a direct thrombin inhibitor indicated: For prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT) ( 1.1 ) As an anticoagulant in adult patients with or at risk for HIT undergoing percutaneous coronary intervention (PCI) ( 1.2 ) 1.1 Heparin-Induced Thrombocytopenia Argatroban Injection is indicated for prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT). 1.2 Percutaneous Coronary Intervention Argatroban Injection is indicated as an anticoagulant in adult patients with or at risk for HIT undergoing percutaneous coronary intervention (PCI).
FDA pharmacologic class: Anti-coagulant and Direct Thrombin Inhibitor.
Source: FDA drug label (Argatroban), Hikma Pharmaceuticals USA Inc., effective May 3, 2026 (SPL set 0cdf3f67-5bf3-4d58-b330-03febdc652bf), via openFDA; the full label on DailyMed
Is there a generic for argatroban?
The FDA approved the first generic argatroban on June 30, 2014. 7 generic applications are approved; 7 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 2 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists argatroban from 8 labelers under a generic (ANDA) application and from 4 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Argatroban injection; a patent listed only for Argatroban In Sodium Chloride injection runs to September 26, 2027. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2000 earliest approval on file
- 2014 first generic approved
- 2027 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has argatroban been recalled?
The FDA's Enforcement Report lists 3 recalls naming argatroban since 2011: 1 Class I (the most serious), 0 Class II, 2 Class III; 0 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of argatroban 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 |
|---|---|---|---|
| August 28, 2018 | Class III | Pfizer Inc. not a listed maker | Failed Impurities/Degradation Specifications; Out of specification stability testing results at the 18 month time point |
| July 6, 2017 | Class III | Hospira Inc., A Pfizer Company | Failed Impurities/Degradation Specifications; out of specification result for denitroquinoline-related impurity during three month time point |
| December 2, 2011 | Class I | Eagle Pharmaceuticals Inc. not a listed maker | A complaint was received from a hospital pharmacy on 11/10/11 for crystalline particulates in a single vial from Lot V10194. … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the argatroban label say about other medicines?
The argatroban label names 4 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name argatroban. 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 |
|---|---|---|
| Acetaminophen | drug interactions | No drug-drug interactions have been demonstrated between argatroban and concomitantly administered aspirin or acetaminophen [ see Clinical Pharmacology (12.3) ]. |
| Aspirin | drug interactions | No drug-drug interactions have been demonstrated between argatroban and concomitantly administered aspirin or acetaminophen [ see Clinical Pharmacology (12.3) ]. |
| Heparin | drug interactions | DRUG INTERACTIONS Heparin: Allow sufficient time for heparin’s effect on activated partial thromboplastin time (aPTT) to decrease before initiating Argatroban Injection therapy. |
| Warfarin | drug interactions | However, the concomitant use of argatroban and warfarin (5 to 7.5 mg initial oral dose, followed by 2.5 to 6 mg/day orally for 6 to 10 days) results in prolongation of the prothrombin time (PT) and International Normalized Ratio (INR) [see Dosage and Administration (2.5 ) and Clinical Pharmacology (12.2) ]. |
Source: FDA drug label (Argatroban), Hikma Pharmaceuticals USA Inc., effective May 3, 2026 (SPL set 0cdf3f67-5bf3-4d58-b330-03febdc652bf), via openFDA; the full label on DailyMed
What do FAERS reports show for argatroban?
The FDA Adverse Event Reporting System holds 1,496 reports that list argatroban among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 318 are coded as a death and 636 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 next?
- Other anti-coagulants
- the pharmacologic class, with prices and generics
- Argatroban side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other