Adlyxin
NDC Package 0024-5745-02

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

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

Adlyxin is lixisenatide is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. Marketed by Sanofi-aventis U.s. Llc, this product is identified by NDC 0024-5745 and is authorized under FDA application BLA208471.

Identification & Billing

NDC Package Code
0024-5745-02
Package Description
1 KIT in 1 CARTON * 3 mL in 1 SYRINGE (0024-5741-01) * 3 mL in 1 SYRINGE (0024-5740-00)
Product Code
0024-5745
11-Digit Billing Format
00024574502
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
Adlyxin
Dosage Form
-
Usage Information
Lixisenatide is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke. Lixisenatide is similar to a natural hormone in your body (incretin). It works by causing insulin release in response to high sugar levels (such as after a meal) and decreasing the amount of sugar your liver makes. Lixisenatide is not a substitute for insulin if you require insulin treatment.

Regulatory & Marketing

Labeler Name
Sanofi-aventis U.s. Llc
FDA Application #
BLA208471
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
07-27-2016
End Marketing Date
09-30-2023
Listing Expiration
09-30-2023
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0024-5745-02 identifies a specific commercial package of 1 kit in 1 carton * 3 ml in 1 syringe (0024-5741-01) * 3 ml in 1 syringe (0024-5740-00) of Adlyxin, labeled by Sanofi-aventis U.s. Llc. 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 Sanofi-aventis U.s. Llc on July 27, 2016. The current certification is valid through September 30, 2023.

What are the primary indications for this medication?

Lixisenatide is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke. Lixisenatide is similar to a natural hormone in your body (incretin). It works by causing insulin release in response to high sugar levels (such as after a meal) and decreasing the amount of sugar your liver makes. Lixisenatide is not a substitute for insulin if you require insulin treatment.

How is this Sanofi-aventis U.s. Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00024574502. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
0024-5745-02
11-Digit CMS (5-4-2)
00024-5745-02

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