Tisseel
NDC Package 0944-8402-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
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.

Tisseel is a . Marketed by Baxalta Us Inc., this product is identified by NDC 0944-8402 and is authorized under FDA application BLA103980.

Identification & Billing

NDC Package Code
0944-8402-01
Package Description
1 SYRINGE, PLASTIC in 1 POUCH / 2 mL in 1 SYRINGE, PLASTIC (0944-8402-02)
Product Code
0944-8402
11-Digit Billing Format
00944840201

Clinical Specifications

Proprietary Name
Tisseel Frozen
Dosage Form
-

Regulatory & Marketing

Labeler Name
Baxalta Us Inc.
FDA Application #
BLA103980
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
02-18-2011
End Marketing Date
07-31-2019
Listing Expiration
07-31-2019
Exclude Flag
D
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0944-8402). Click a package code to view its specific billing and regulatory data.

0944-8402-03
1 SYRINGE, PLASTIC in 1 POUCH / 4 mL in 1 SYRINGE, PLASTIC (0944-8402-04)
0944-8402-03
1 SYRINGE, PLASTIC in 1 POUCH / 4 mL in 1 SYRINGE, PLASTIC (0944-8402-04)
0944-8402-09
1 SYRINGE, PLASTIC in 1 POUCH / 10 mL in 1 SYRINGE, PLASTIC (0944-8402-10)
0944-8402-09
1 SYRINGE, PLASTIC in 1 POUCH / 10 mL in 1 SYRINGE, PLASTIC (0944-8402-10)
0944-8402-10
1 SYRINGE, PLASTIC in 1 CARTON / 10 mL in 1 SYRINGE, PLASTIC

* 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 0944-8402-01 identifies a specific commercial package of 1 syringe, plastic in 1 pouch / 2 ml in 1 syringe, plastic (0944-8402-02) of Tisseel Frozen, labeled by Baxalta Us Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Baxalta Us Inc. on February 18, 2011. The current certification is valid through July 31, 2019.

How is this Baxalta Us Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00944840201. 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)
0944-8402-01
11-Digit CMS (5-4-2)
00944-8402-01

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