Tachosil Patch
NDC Package 83078-704-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Tachosil (thrombin human and fibrinogen) patches is tachoSil 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. This formulation utilizes a patch delivery system. Marketed by Corza Medical Gmbh, this product is identified by NDC 83078-704 and is authorized under FDA application BLA125351.

Identification & Billing

NDC Package Code
83078-704-01
Package Description
1 POUCH in 1 CARTON / 1 BLISTER PACK in 1 POUCH (83078-704-00) / 1 PATCH in 1 BLISTER PACK (83078-704-99)
Product Code
83078-704
11-Digit Billing Format
83078070401
RxNorm Crosswalk
  • RxCUI: 1001591 - fibrinogen / thrombin (human) 3.7 inch x 1.9 inch Medicated Patch
  • RxCUI: 1001591 - fibrinogen, human 337 MG / thrombin, human 123 UNT Medicated Patch
  • RxCUI: 1001591 - fibrinogen, human / thrombin, human 3.7 inch x 1.9 inch Medicated Patch
  • RxCUI: 1001593 - TachoSil 3.7 inch x 1.9 inch Medicated Patch
  • RxCUI: 1001593 - fibrinogen, human 337 MG / thrombin, human 123 UNT Medicated Patch [TachoSil]

Clinical Specifications

Proprietary Name
Tachosil
Non-Proprietary Name
Thrombin Human And Fibrinogen
Substance Name
Fibrinogen Human; Human Thrombin
Dosage Form
Patch - A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms ‘extended release film’ and ‘system’.
Administration Route
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
Pharmacologic Class
Usage Information
TachoSil 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.

Regulatory & Marketing

Labeler Name
Corza Medical Gmbh
Product Type
Human Prescription Drug
FDA Application #
BLA125351
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
08-29-2025
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
Yes

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 83078-704-01 identifies a specific commercial package of 1 pouch in 1 carton / 1 blister pack in 1 pouch (83078-704-00) / 1 patch in 1 blister pack (83078-704-99) of Tachosil, a human prescription drug labeled by Corza Medical Gmbh. This patch is formulated for topical use and contains fibrinogen human; human thrombin as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Corza Medical Gmbh on August 29, 2025. The current certification is valid through December 31, 2026.

How is this Corza Medical Gmbh product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83078070401. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
83078-704-01
11-Digit CMS (5-4-2)
83078-0704-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.