dupixent

Generic: dupilumab

Labeler: sanofi-aventis u.s. llc
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name dupixent
Generic Name dupilumab
Labeler sanofi-aventis u.s. llc
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

dupilumab 200 mg/1.14mL

Manufacturer
sanofi-aventis U.S. LLC

Identifiers & Regulatory

Product NDC 0024-5918
Product ID 0024-5918_ebbdf352-f837-49b9-8e31-5ec55f2131b1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761055
Listing Expiration 2027-12-31
Marketing Start 2018-10-19

Pharmacologic Class

Established (EPC)
interleukin-4 receptor alpha antagonist [epc]
Mechanism of Action
interleukin 4 receptor alpha antagonists [moa]
Chemical Structure
antibodies, monoclonal [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00245918
Hyphenated Format 0024-5918

Supplemental Identifiers

RxCUI
1876401 1876406 2099300 2099302 2375327 2375329 2559706 2559707 2583634 2583635
UNII
420K487FSG
NUI
N0000193342 N0000193341 M0001357

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name dupixent (source: ndc)
Generic Name dupilumab (source: ndc)
Application Number BLA761055 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 200 mg/1.14mL
source: ndc
Packaging
  • 2 SYRINGE, GLASS in 1 CARTON (0024-5918-01) / 1.14 mL in 1 SYRINGE, GLASS (0024-5918-00)
  • 2 SYRINGE, GLASS in 1 CARTON (0024-5918-02) / 1.14 mL in 1 SYRINGE, GLASS (0024-5918-20)
source: ndc

Packages (2)

0024-5918-01 2 SYRINGE, GLASS in 1 CARTON (0024-5918-01) / 1.14 mL in 1 SYRINGE, GLASS (0024-5918-00) 0024-5918-02 2 SYRINGE, GLASS in 1 CARTON (0024-5918-02) / 1.14 mL in 1 SYRINGE, GLASS (0024-5918-20)

Ingredients (1)

dupilumab (200 mg/1.14mL)

Linked Drug Pages (1)

Dupixent ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "ebbdf352-f837-49b9-8e31-5ec55f2131b1", "openfda": {"nui": ["N0000193342", "N0000193341", "M0001357"], "unii": ["420K487FSG"], "rxcui": ["1876401", "1876406", "2099300", "2099302", "2375327", "2375329", "2559706", "2559707", "2583634", "2583635"], "spl_set_id": ["595f437d-2729-40bb-9c62-c8ece1f82780"], "pharm_class_cs": ["Antibodies, Monoclonal [CS]"], "pharm_class_epc": ["Interleukin-4 Receptor alpha Antagonist [EPC]"], "pharm_class_moa": ["Interleukin 4 Receptor alpha Antagonists [MoA]"], "manufacturer_name": ["sanofi-aventis U.S. LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 SYRINGE, GLASS in 1 CARTON (0024-5918-01)  / 1.14 mL in 1 SYRINGE, GLASS (0024-5918-00)", "package_ndc": "0024-5918-01", "marketing_start_date": "20181019"}, {"sample": true, "description": "2 SYRINGE, GLASS in 1 CARTON (0024-5918-02)  / 1.14 mL in 1 SYRINGE, GLASS (0024-5918-20)", "package_ndc": "0024-5918-02", "marketing_start_date": "20181019"}], "brand_name": "Dupixent", "product_id": "0024-5918_ebbdf352-f837-49b9-8e31-5ec55f2131b1", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Antibodies", "Monoclonal [CS]", "Interleukin 4 Receptor alpha Antagonists [MoA]", "Interleukin-4 Receptor alpha Antagonist [EPC]"], "product_ndc": "0024-5918", "generic_name": "Dupilumab", "labeler_name": "sanofi-aventis U.S. LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dupixent", "active_ingredients": [{"name": "DUPILUMAB", "strength": "200 mg/1.14mL"}], "application_number": "BLA761055", "marketing_category": "BLA", "marketing_start_date": "20181019", "listing_expiration_date": "20271231"}