Prescription medicine
Fibrinogen human and human thrombin Brand names: Tachosil
Fibrinogen human and human thrombin (Tachosil) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the fibrinogen human and human thrombin FDA label on DailyMed (effective October 8, 2025); every fibrinogen human and human thrombin label on DailyMed.
Highlights of the record
FDA label of October 8, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageTachoSil is a fibrin sealant patch indicated for use with manual compression in adult and pediatric patients as an adjunct to hemostasis in cardiovascular and hepatic surgery when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical.
Forms and strengths
- 5.5 mg
Patch.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 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)
- No recall recorded
- FAERS reports
- 334 through July 30, 2026
What is fibrinogen human and human thrombin used for?
From the label: indications and usageTachoSil is a fibrin sealant patch indicated for use with manual compression in adult and pediatric patients as an adjunct to hemostasis in cardiovascular and hepatic surgery when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. Limitations for Use TachoSil cannot safely or effectively be used in place of sutures or other form of mechanical ligation for the treatment of major arterial or venous bleeding. Not for use in children under one month of age. […]
FDA pharmacologic class: Human Blood Coagulation Factor.
Source: FDA drug label (TachoSil), Corza Medical GmbH, effective October 8, 2025 (SPL set 0c324332-290f-413f-820c-8c9a971a2766), via openFDA; the full label on DailyMed
Is there a generic for fibrinogen human and human thrombin (Tachosil)?
No generic fibrinogen human and human thrombin is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for fibrinogen human and human thrombin?
The FDA Adverse Event Reporting System holds 334 reports that list fibrinogen human and human thrombin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 27 are coded as a death and 129 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.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Fibrinogen human and human thrombin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other