Prescription drug · BLA
Dupixent (dupilumab) NDC 0024-5919
Dupilumab 200 mg/1.14mL · Injection, Solution · Subcutaneous · Sanofi-Aventis U.S. LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0024-5919-02 | 00024591902 | 2 SYRINGE, GLASS in 1 CARTON (0024-5919-02) / 1.14 mL in 1 SYRINGE, GLASS (0024-5919-00)Marketed from Jun 14, 2021 | |
| 0024-5919-20 | 00024591920 | 2 SYRINGE, GLASS in 1 CARTON (0024-5919-20) / 1.14 mL in 1 SYRINGE, GLASS (0024-5919-01)Marketed from Jun 14, 2021 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Dupixent
- Generic name (nonproprietary)
- dupilumab
- Active ingredients
- Dupilumab — 200 mg/1.14mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- Sanofi-Aventis U.S. LLC
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761055
- Marketing start
- Listing expires
- Other FDA classes
- Monoclonal (Chemical structure)Interleukin 4 Receptor alpha Antagonists (Mechanism)
- Identifiers
- Product ID 0024-5919_06b9c64b-52b1-490b-b118-bd079e69264eSPL ID 06b9c64b-52b1-490b-b118-bd079e69264eSPL set ID 595f437d-2729-40bb-9c62-c8ece1f82780RxCUI 1876401, 1876406, 2099300, 2099302, 2375327, 2375329, 2559706, 2559707UNII 420K487FSG
- Pharmacologic class
- Interleukin-4 Receptor alpha Antagonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeMed-Code curated
No drug-specific HCPCS code in Med-Code’s directory for this product.
Med-Code's directory has no drug-specific HCPCS code for dupilumab. It is usually self-administered and billed by NDC through a pharmacy benefit.
If a payer accepts an unclassified code for it in a clinical setting, that would be J3590 (Unclassified biologics), with the NDC, quantity and often the invoice. Acceptance varies by payer.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N400024591902followed by a unit qualifier and the quantityPackage 00024-5919-02. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
DUPIXENT is an interleukin-4 receptor alpha antagonist indicated: Atopic Dermatitis for the treatment of adult and pediatric patients aged 6 months and older with moderate-to-severe AD whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT can be used with or without topical corticosteroids. ( 1.1 ) Asthma as an add-on maintenance treatment of adult and pediatric patients aged 6 years and older with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid dependent asthma. ( 1.2 ) Limitations of Use: Not for the relief of acute bronchospasm or status asthmaticus. ( 1.2 ) Chroni…
Excerpt only. Read the full label for complete information.
Other NDCs under BLA 761055
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Dupixentdupilumab | Dupilumab 300 mg/2mL | Injection, SolutionSubcutaneous | Sanofi-Aventis U.S. LLC | 0024-5915 |
| Dupixentdupilumab | Dupilumab 200 mg/1.14mL | Injection, SolutionSubcutaneous | Sanofi-Aventis U.S. LLC | 0024-5918 |
| Dupixentdupilumab | Dupilumab 300 mg/2mL | Injection, SolutionSubcutaneous | Sanofi-Aventis U.S. LLC | 0024-5914 |