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  5. NDC Package Code: 0338-9564-01 Tisseel Fibrin Sealant

NDC Package 0338-9564-01 Tisseel Fibrin Sealant

Fibrinogen Human,Human Thrombin Solution Topical - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
0338-9564-01
Package Description:
4 mL in 1 SYRINGE, PLASTIC
Product Code:
0338-9564
Proprietary Name:
Tisseel Fibrin Sealant
Non-Proprietary Name:
Fibrinogen Human, Human Thrombin
Substance Name:
Fibrinogen Human; Human Thrombin
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.
11-Digit NDC Billing Format:
00338956401
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
4 ML
NDC to 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
    • Product Type:
    Plasma Derivative
    Labeler Name:
    Baxter Healthcare Corporation
    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(s):
  • 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):
  • FIBRINOGEN HUMAN 86.5 mg/mL
  • HUMAN THROMBIN 500 [iU]/mL
    • Pharmacologic Class(es):
  • Blood Coagulation Factors - [CS]
  • Blood Coagulation Factors - [CS]
  • Human Blood Coagulation Factor - [EPC] (Established Pharmacologic Class)
  • Increased Coagulation Activity - [PE] (Physiologic Effect)
  • Increased Coagulation Factor Activity - [PE] (Physiologic Effect)
    • Sample Package:
    No
    FDA Application Number:
    BLA103980
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    05-01-1998
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 0338-9564-01?

    The NDC Packaged Code 0338-9564-01 is assigned to a package of 4 ml in 1 syringe, plastic of Tisseel Fibrin Sealant, a plasma derivative labeled by Baxter Healthcare Corporation. The product's dosage form is solution and is administered via topical form.This product is billed per "ML" milliliter and contains an estimated amount of 4 billable units per package.

    Is NDC 0338-9564 included in the NDC Directory?

    Yes, Tisseel Fibrin Sealant with product code 0338-9564 is active and included in the NDC Directory. The product was first marketed by Baxter Healthcare Corporation on May 01, 1998 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 0338-9564-01?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume. The calculated billable units for this package is 4.

    What is the 11-digit format for NDC 0338-9564-01?

    The 11-digit format is 00338956401. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    4-4-20338-9564-015-4-200338-9564-01