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 ID0024-5916_3d3b448d-9b8a-4d75-9dc3-b93ac33224d9
NDC0024-5916
Product TypeHuman Prescription Drug
Proprietary NameDupixent
Generic NameDupilumab
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2017-03-28
Marketing CategoryBLA / BLA
Application NumberBLA761055
Labeler Namesanofi-aventis U.S. LLC
Substance NameDUPILUMAB
Active Ingredient Strength300 mg/2mL
Pharm ClassesInterleukin-4 Receptor alpha Antagonist [EPC],Interleukin 4 Receptor alpha Antagonists [MoA],Antibodies, Monoclonal [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0024-5916-01

2 SYRINGE, GLASS in 1 CARTON (0024-5916-01) > 2 mL in 1 SYRINGE, GLASS
Marketing Start Date2017-03-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0024-5916-01 [00024591601]

Dupixent INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA761055
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-03-28

Drug Details

Active Ingredients

IngredientStrength
DUPILUMAB300 mg/2mL

OpenFDA Data

SPL SET ID:595f437d-2729-40bb-9c62-c8ece1f82780
Manufacturer
UNII
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"

    NDCBrand NameGeneric Name
    0024-5911DupixentDupilumab
    0024-5914DupixentDupilumab
    0024-5915DupixentDupilumab
    0024-5916DupixentDupilumab
    0024-5918DupixentDupixent

    Trademark Results [Dupixent]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    DUPIXENT
    DUPIXENT
    97429846 not registered Live/Pending
    Sanofi Biotechnology
    2022-05-26
    DUPIXENT
    DUPIXENT
    87202613 5235634 Live/Registered
    Sanofi Biotechnology
    2016-10-13
    DUPIXENT
    DUPIXENT
    86807623 4978127 Live/Registered
    Sanofi Biotechnology
    2015-11-03

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