Tisseel Solution
NDC Package 0338-9564-01

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

Package Information

Tisseel (fibrinogen human, human thrombin) solution is hemostasis: TISSEEL is a fibrin sealant indicated for use as an adjunct to hemostasis in adult and pediatric patients (>1 month of age) undergoing surgery when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. This formulation utilizes a solution delivery system. Marketed by Baxter Healthcare Corporation, this product is identified by NDC 0338-9564 and is authorized under FDA application BLA103980.

Identification & Billing

NDC Package Code
0338-9564-01
Package Description
4 mL in 1 SYRINGE, PLASTIC
Product Code
0338-9564
11-Digit Billing Format
00338956401
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
4 ML
RxNorm Crosswalk
  • RxCUI: 2003660 - fibrin sealant (thrombin 625 UNT/ML, human) Topical Solution
  • RxCUI: 2003660 - fibrinogen, human 106 MG/ML / thrombin, human 625 UNT/ML Topical Solution
  • RxCUI: 2003662 - TISSEEL, fibrin sealant (human) Topical Solution
  • RxCUI: 2003662 - fibrinogen, human 106 MG/ML / thrombin, human 625 UNT/ML Topical Solution [Tisseel]
  • RxCUI: 2003663 - fibrin sealant (thrombin 625 UNT/mL, human) topical solution 2 mL Prefilled Syringe, frozen

Clinical Specifications

Proprietary Name
Tisseel Fibrin Sealant
Non-Proprietary Name
Fibrinogen Human, Human Thrombin
Substance Name
Fibrinogen Human; Human Thrombin
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
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
Hemostasis: TISSEEL is a fibrin sealant indicated for use as an adjunct to hemostasis in adult and pediatric patients (>1 month of age) undergoing surgery when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. TISSEEL is effective in heparinized patients.Sealing: TISSEEL is a fibrin sealant indicated as an adjunct to standard surgical techniques (such as suture and ligature) to prevent leakage from colonic anastomoses following the reversal of temporary colostomies.

Regulatory & Marketing

Labeler Name
Baxter Healthcare Corporation
Product Type
Plasma Derivative
FDA Application #
BLA103980
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
05-01-1998
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

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 0338-9564-01 identifies a specific commercial package of 4 ml in 1 syringe, plastic of Tisseel Fibrin Sealant, a plasma derivative labeled by Baxter Healthcare Corporation. This product is billed per "ML" milliliter and contains an estimated amount of 4 billable units per package. This solution 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 Baxter Healthcare Corporation on May 01, 1998. The current certification is valid through December 31, 2026.

How is this Baxter Healthcare Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00338956401. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 4 total billable units per package. 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 (4-4-2)
0338-9564-01
11-Digit CMS (5-4-2)
00338-9564-01

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