Dupixent
NDC 0024-5911
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.
Dupixent is a BLA-approved product labeled by Sanofi-aventis U.s. Llc. This medication is used to treat a skin condition called eczema (atopic dermatitis). It is supplied as a product. This product entry covers the primary NDC 0024-5911 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
0024-5911
Proprietary Name:
Dupixent
Product Type: [3]
Code Navigator:
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
0024
Product Label ID:
FDA Application Number: [6]
BLA761055
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.
Marketing Timeline
Start Marketing Date: [9]
10-20-2021
End Marketing Date: [10]
08-05-2026
Listing Expiration Date: [11]
08-05-2026
Exclude Flag: [12]
D
Code Structure Chart
Product Details
What is NDC 0024-5911?
The NDC code 0024-5911 is assigned by the FDA to the product Dupixent. This pharmaceutical product is labeled by Sanofi-aventis U.s. Llc and is currently categorized as listed product. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 0024-5911-02, 0024-5911-20. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
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.
What is the NDC to RxNorm Crosswalk for this product?
RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
- RxCUI: 1876401 - dupilumab 300 MG in 2 ML Prefilled Syringe
- RxCUI: 1876401 - 2 ML dupilumab 150 MG/ML Prefilled Syringe
- RxCUI: 1876401 - dupilumab 300 MG per 2 ML Prefilled Syringe
- RxCUI: 1876406 - DUPIXENT 300 MG in 2 ML Prefilled Syringe
- RxCUI: 1876406 - 2 ML dupilumab 150 MG/ML Prefilled Syringe [Dupixent]
* Please review the full disclaimer at the bottom of this page.
Patient Education
Dupilumab Injection
Dupilumab injection is used to treat the symptoms of eczema (atopic dermatitis; a skin disease that causes the skin to be dry and itchy and to sometimes develop red, scaly rashes) in adults and children 6 months of age and older who cannot use other medications for their condition or whose eczema has not responded to other medications. It is also used along with other medications to prevent wheezing, shortness of breath, coughing, and chest tightness due to certain types of asthma in adults and children 6 years and older whose symptoms are not controlled with other medications. Dupilumab injection is also used along with other medications to treat chronic rhinosinusitis with nasal polyposis (ongoing runny nose, sinus swelling and/or nasal congestion, with or without a reduced sense of smell or pain and pressure in the face) in adults whose symptoms are not controlled with other medications. It is also used to treat eosinophilic esophagitis (EoE; a condition that involves high levels of blood cells in the esophagus [tube that connects the mouth to the stomach] that may damage tissues of the esophagus) in adults and children 12 years of age and older who weigh at least 88 pounds (40 kg). Dupilumab injection is also used to treat prurigo nodularis (a skin condition that causes crusty lumps on the skin and severe itching) in adults. Dupilumab injection is in a class of medications called monoclonal antibodies. It works by stopping the action of certain substances in the body that cause inflammation.
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* Please review the full disclaimer at the bottom of this page.
Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the End Marketing Date? This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".
