NDC 0024-5916

Dupixent

Dupilumab

Dupixent is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Sanofi-aventis U.s. Llc. The primary component is Dupilumab.

• Product ID: 0024-5916_3d3b448d-9b8a-4d75-9dc3-b93ac33224d9
• NDC: 0024-5916
• Product Type: Human Prescription Drug
• Proprietary Name: Dupixent
• Generic Name: Dupilumab
• Dosage Form: Injection, Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2017-03-28
• Marketing Category: BLA / BLA
• Application Number: BLA761055
• Labeler Name: sanofi-aventis U.S. LLC
• Substance Name: DUPILUMAB
• Active Ingredient Strength: 300 mg/2mL
• Pharm Classes: Interleukin-4 Receptor alpha Antagonist [EPC],Interleukin 4 Receptor alpha Antagonists [MoA],Antibodies, Monoclonal [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0024-5916-01

2 SYRINGE, GLASS in 1 CARTON (0024-5916-01) > 2 mL in 1 SYRINGE, GLASS

• Marketing Start Date: 2017-03-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0024-5916-01 [00024591601]

Dupixent INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA761055
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-03-28

Drug Details

Active Ingredients

Ingredient	Strength
DUPILUMAB	300 mg/2mL

OpenFDA Data

• SPL SET ID: 595f437d-2729-40bb-9c62-c8ece1f82780
• Manufacturer:
  • sanofi-aventis U.S. LLC
• UNII:
  • 420K487FSG
• RxNorm Concept Unique ID - RxCUI:
  • 1876406
  • 2099300
  • 2099302
  • 1876401

Pharmacological Class

• Interleukin-4 Receptor alpha Antagonist [EPC]
• Interleukin 4 Receptor alpha Antagonists [MoA]
• Antibodies
• Monoclonal [CS]

NDC Crossover Matching brand name "Dupixent" or generic name "Dupilumab"

NDC	Brand Name	Generic Name
0024-5911	Dupixent	Dupilumab
0024-5914	Dupixent	Dupilumab
0024-5915	Dupixent	Dupilumab
0024-5916	Dupixent	Dupilumab
0024-5918	Dupixent	Dupixent