Search by Drug Name or NDC
NDC 00024-5919-20 Dupixent 200 mg/1.14mL Details
Dupixent 200 mg/1.14mL
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.
MedlinePlus Drug Summary
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 in a class of medications called monoclonal antibodies. It works by stopping the action of certain substances in the body that cause inflammation.
Related Packages: 00024-5919-20Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dupilumab Injection
Product Information
NDC | 00024-5919 |
---|---|
Product ID | 0024-5919_214be693-3f1d-42ee-b72a-f3f210a4ce43 |
Associated GPIs | 9027302000D215 |
GCN Sequence Number | 081615 |
GCN Sequence Number Description | dupilumab PEN INJCTR 200MG/1.14 SUBCUT |
HIC3 | V4D |
HIC3 Description | INTERLEUKIN-4(IL-4) RECEPTOR ALPHA ANTAGONIST, MAB |
GCN | 48785 |
HICL Sequence Number | 044180 |
HICL Sequence Number Description | DUPILUMAB |
Brand/Generic | Brand |
Proprietary Name | Dupixent |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Dupilumab |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | INJECTION, SOLUTION |
Route | SUBCUTANEOUS |
Active Ingredient Strength | 200 |
Active Ingredient Units | mg/1.14mL |
Substance Name | DUPILUMAB |
Labeler Name | sanofi-aventis U.S. LLC |
Pharmaceutical Class | Antibodies, Monoclonal [CS], Interleukin 4 Receptor alpha Antagonists [MoA], Interleukin-4 Receptor alpha Antagonist [EPC] |
DEA Schedule | n/a |
Marketing Category | BLA |
Application Number | BLA761055 |
Listing Certified Through | 2024-12-31 |
Package
NDC 00024-5919-20 (00024591920)
NDC Package Code | 0024-5919-20 |
---|---|
Billing NDC | 00024591920 |
Package | 2 SYRINGE, GLASS in 1 CARTON (0024-5919-20) / 1.14 mL in 1 SYRINGE, GLASS (0024-5919-01) |
Marketing Start Date | 2021-06-14 |
NDC Exclude Flag | N |
Pricing Information | N/A |