Aralast
NDC Package 0944-2802-02

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.

Aralast is a medication used to treat lung problems (emphysema) caused by a certain inherited disease (alpha-1-proteinase inhibitor deficiency). Marketed by Baxter Healthcare Corporation, this product is identified by NDC 0944-2802 and is authorized under FDA application BLA125039.

Identification & Billing

NDC Package Code
0944-2802-02
Package Description
1 KIT in 1 CARTON * 1 VIAL, GLASS in 1 CARTON / 50 mL in 1 VIAL, GLASS * 1 VIAL, GLASS in 1 CARTON / 50 mL in 1 VIAL, GLASS
Product Code
0944-2802
11-Digit Billing Format
00944280202
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.

Clinical Specifications

Proprietary Name
Aralast NP
Dosage Form
-
Usage Information
This medication is used to treat lung problems (emphysema) caused by a certain inherited disease (alpha-1-proteinase inhibitor deficiency). In people with this condition, lung damage is caused by elastase, a natural substance that the body needs to kill bacteria in the lungs. Normally, a protein (alpha-1-proteinase inhibitor) stops elastase from working when it is no longer needed. However, in people who do not make enough of this protein, elastase does not stop working and damages the lungs. This medication replaces the missing alpha-1-proteinase inhibitor and helps to prevent further lung damage.

Regulatory & Marketing

Labeler Name
Baxter Healthcare Corporation
FDA Application #
BLA125039
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
04-19-2010
End Marketing Date
11-09-2014
Listing Expiration
11-09-2014
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 (0944-2802). Click a package code to view its specific billing and regulatory data.

0944-2802-01
1 KIT in 1 CARTON * 1 VIAL, GLASS in 1 CARTON / 25 mL in 1 VIAL, GLASS * 1 VIAL, GLASS in 1 CARTON / 25 mL in 1 VIAL, GLASS

* 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 0944-2802-02 identifies a specific commercial package of 1 kit in 1 carton * 1 vial, glass in 1 carton / 50 ml in 1 vial, glass * 1 vial, glass in 1 carton / 50 ml in 1 vial, glass of Aralast NP, labeled by Baxter Healthcare Corporation. 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 Baxter Healthcare Corporation on April 19, 2010. The current certification is valid through November 09, 2014.

What are the primary indications for this medication?

This medication is used to treat lung problems (emphysema) caused by a certain inherited disease (alpha-1-proteinase inhibitor deficiency). In people with this condition, lung damage is caused by elastase, a natural substance that the body needs to kill bacteria in the lungs. Normally, a protein (alpha-1-proteinase inhibitor) stops elastase from working when it is no longer needed. However, in people who do not make enough of this protein, elastase does not stop working and damages the lungs. This medication replaces the missing alpha-1-proteinase inhibitor and helps to prevent further lung damage.

How is this Baxter Healthcare Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00944280202. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. 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)
0944-2802-02
11-Digit CMS (5-4-2)
00944-2802-02

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