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  5. NDC Package Code: 0338-8503-10 Artiss Fibrin Sealant

NDC Package 0338-8503-10 Artiss Fibrin Sealant

View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

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:
0338-8503-10
Package Description:
1 SYRINGE, PLASTIC in 1 CARTON / 10 mL in 1 SYRINGE, PLASTIC (0338-8503-09)
Product Code:
0338-8503
Proprietary Name:
Artiss Fibrin Sealant
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:
00338850310
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
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]
Labeler Name:
Baxter Healthcare Corporation
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
End Marketing Date:
04-30-2024
Listing Expiration Date:
04-30-2024
Exclude Flag:
D
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.

Other Product Packages

The following packages are also available for this product:

NDC Package CodePackage Description
0338-8503-021 SYRINGE, PLASTIC in 1 CARTON / 2 mL in 1 SYRINGE, PLASTIC (0338-8503-01)
0338-8503-041 SYRINGE, PLASTIC in 1 CARTON / 4 mL in 1 SYRINGE, PLASTIC (0338-8503-03)

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 0338-8503-10?

The NDC Packaged Code 0338-8503-10 is assigned to a package of 1 syringe, plastic in 1 carton / 10 ml in 1 syringe, plastic (0338-8503-09) of Artiss Fibrin Sealant, labeled by Baxter Healthcare Corporation. The product's dosage form is and is administered via form.

Is NDC 0338-8503 included in the NDC Directory?

No, Artiss Fibrin Sealant with product code 0338-8503 is excluded from the NDC Directory because it was discontinued by the manufacturer. 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 April 30, 2024 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 0338-8503-10?

The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

What is the 11-digit format for NDC 0338-8503-10?

The 11-digit format is 00338850310. 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
4-4-20338-8503-105-4-200338-8503-10