Dupixent
NDC Package 0024-5916-01

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.

Dupixent is a medication used to treat a skin condition called eczema (atopic dermatitis). Marketed by Sanofi-aventis U.s. Llc, this product is identified by NDC 0024-5916 and is authorized under FDA application BLA761055.

Identification & Billing

NDC Package Code
0024-5916-01
Package Description
2 SYRINGE, GLASS in 1 CARTON / 2 mL in 1 SYRINGE, GLASS
Product Code
0024-5916
11-Digit Billing Format
00024591601

Clinical Specifications

Proprietary Name
Dupixent
Dosage Form
-
Usage Information
This medication is used to treat a skin condition called eczema (atopic dermatitis). It is also used along with other medications to help control and prevent symptoms (such as wheezing and shortness of breath) caused by asthma. In addition, dupilumab may be used to reduce symptoms caused by nasal polyps and the long-term swelling of the sinuses and nasal passage (chronic rhinosinusitis with nasal polyposis). Dupilumab belongs to a class of drugs known as monoclonal antibodies. It works by blocking certain natural proteins in your body (interleukin-4 and interleukin-13) that may cause inflammation and swelling. This medication should not be used to relieve sudden asthma attacks. If an asthma attack occurs, use your quick-relief inhaler (such as albuterol, also called salbutamol in some countries) as prescribed.

Regulatory & Marketing

Labeler Name
Sanofi-aventis U.s. Llc
FDA Application #
BLA761055
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
03-28-2017
End Marketing Date
06-13-2022
Listing Expiration
06-13-2022
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 0024-5916-01 identifies a specific commercial package of 2 syringe, glass in 1 carton / 2 ml in 1 syringe, glass of Dupixent, 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 March 28, 2017. The current certification is valid through June 13, 2022.

What are the primary indications for this medication?

This medication is used to treat a skin condition called eczema (atopic dermatitis). It is also used along with other medications to help control and prevent symptoms (such as wheezing and shortness of breath) caused by asthma. In addition, dupilumab may be used to reduce symptoms caused by nasal polyps and the long-term swelling of the sinuses and nasal passage (chronic rhinosinusitis with nasal polyposis). Dupilumab belongs to a class of drugs known as monoclonal antibodies. It works by blocking certain natural proteins in your body (interleukin-4 and interleukin-13) that may cause inflammation and swelling. This medication should not be used to relieve sudden asthma attacks. If an asthma attack occurs, use your quick-relief inhaler (such as albuterol, also called salbutamol in some countries) as prescribed.

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: 00024591601. 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)
0024-5916-01
11-Digit CMS (5-4-2)
00024-5916-01

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