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  5. NDC Package Code: 0338-4301-02 Tisseel Fibrin Sealant

NDC Package 0338-4301-02 Tisseel Fibrin Sealant

Fibrinogen Human,Human Thrombin Kit - 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:
0338-4301-02
Package Description:
1 KIT in 1 CARTON * 1 mL in 1 VIAL, GLASS (0338-7332-01) * 1 mL in 1 VIAL, GLASS (0338-7201-01) * 1 mL in 1 VIAL, GLASS (0338-7401-01) * 1 mL in 1 VIAL, GLASS (0338-7112-01)
Product Code:
0338-4301
Proprietary Name:
Tisseel Fibrin Sealant
Non-Proprietary 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:
00338430102
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
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:
    Kit - A packaged collection of related material.
    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 0338-4301-02?

    The NDC Packaged Code 0338-4301-02 is assigned to a package of 1 kit in 1 carton * 1 ml in 1 vial, glass (0338-7332-01) * 1 ml in 1 vial, glass (0338-7201-01) * 1 ml in 1 vial, glass (0338-7401-01) * 1 ml in 1 vial, glass (0338-7112-01) of Tisseel Fibrin Sealant, a plasma derivative labeled by Baxter Healthcare Corporation. The product's dosage form is kit and is administered via form.

    Is NDC 0338-4301 included in the NDC Directory?

    Yes, Tisseel Fibrin Sealant with product code 0338-4301 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 0338-4301-02?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units.

    What is the 11-digit format for NDC 0338-4301-02?

    The 11-digit format is 00338430102. 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
    4-4-20338-4301-025-4-200338-4301-02