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  5. NDC Package Code: 0338-9641-01 Artiss Fibrin Sealant

NDC Package 0338-9641-01 Artiss Fibrin Sealant

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

Table of Contents

    1. Package Information
    2. NDC HCPCS Crosswalk
    3. 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:
0338-9641-01
Package Description:
10 mL in 1 SYRINGE, PLASTIC
Product Code:
0338-9641
Proprietary Name:
Artiss Fibrin Sealant
Non-Proprietary Name:
Fibrinogen Human, Human Thrombin
Substance Name:
Fibrinogen Human; Human Thrombin
Usage Information:
ARTISS is a fibrin sealant indicated to:•Adhere autologous skin grafts to surgically prepared wound beds resulting from burns in adult and pediatric populations greater than or equal to 1 year of age.•Adhere tissue flaps during facial rhytidectomy surgery (face-lift).ARTISS is not indicated as an adjunct to hemostasis.
11-Digit NDC Billing Format:
00338964101
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
10 ML
NDC to RxNorm Crosswalk:
  • RxCUI: 1305891 - fibrin sealant (thrombin 6.5 UNT/mL, human) topical solution 2 mL Prefilled Syringe, frozen
  • RxCUI: 1305891 - 2 ML fibrinogen, human 106 MG/ML / thrombin, human 6.5 UNT/ML Prefilled Syringe
  • RxCUI: 1305891 - fibrin sealant (thrombin 6.5 UNT/ML, human) topical solution 2 ML Prefilled Syringe, frozen
  • RxCUI: 1305892 - ARTISS (Frozen) fibrin sealant (human) topical solution 2 mL Prefilled Syringe
  • RxCUI: 1305892 - 2 ML fibrinogen, human 106 MG/ML / thrombin, human 6.5 UNT/ML Prefilled Syringe [Artiss]
    • 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 4 [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:
    BLA125266
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    03-19-2008
    Listing Expiration Date:
    12-31-2025
    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.

    NDC HCPCS Crosswalk

    This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

    NDC 0338-9641-01 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    00338964101C9250Artiss fibrin sealant2 ML10155

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0338-9641-01?

    The NDC Packaged Code 0338-9641-01 is assigned to a package of 10 ml in 1 syringe, plastic of Artiss 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 10 billable units per package.

    Is NDC 0338-9641 included in the NDC Directory?

    Yes, Artiss Fibrin Sealant with product code 0338-9641 is active and included in the NDC Directory. The product was first marketed by Baxter Healthcare Corporation on March 19, 2008 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 0338-9641-01?

    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 10.

    What is the 11-digit format for NDC 0338-9641-01?

    The 11-digit format is 00338964101. 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
    4-4-20338-9641-015-4-200338-9641-01