FDA.reportPublic FDA data

Dupixent

Product NDC
0024-5915
11-digit product format
000245915
Labeler code
0024
Product ID
0024-5915_b44139c4-a8c5-4a25-8809-b2183a0addbd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dupilumab
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Sanofi-Aventis U.S. LLC
Application
BLA761055
Marketing category
BLA
Marketing start
2020-06-19
Substance
DUPILUMAB
Active strength
300 mg/2mL
Pharmacologic classes
Antibodies, Monoclonal [CS], Interleukin 4 Receptor alpha Antagonists [MoA], Interleukin-4 Receptor alpha Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dupixent
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DUPILUMAB300 mg/2mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii420K487FSG
Rxcui1876401, 1876406, 2099300, 2099302, 2375327, 2375329, 2559706, 2559707, 2583634, 2583635

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
5e742946-05d0-4c58-8341-b0f3b1387bd3Product name220220118
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0024-5915-00Dupixent2 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION256
0024-5915-01Dupixent2 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION256
0024-5915-02Dupixent2 in 1 CARTONINJECTION, SOLUTION256
0024-5915-20Dupixent2 in 1 CARTONINJECTION, SOLUTION256

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0024-5915DUPIXENT (DUPILUMAB) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC]46Current NDC, Legacy NDC, 4 package rows20250429_595f437d-2729-40bb-9c62-c8ece1f82780.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2583634dupilumab 100 MG in 0.67 ML Prefilled SyringePSN595f437d-2729-40bb-9c62-c8ece1f8278056
2559706dupilumab 200 MG in 1.14 ML Auto-InjectorPSN595f437d-2729-40bb-9c62-c8ece1f8278056
2099300dupilumab 200 MG in 1.14 mL Prefilled SyringePSN595f437d-2729-40bb-9c62-c8ece1f8278056
2375327dupilumab 300 MG in 2 ML Auto-InjectorPSN595f437d-2729-40bb-9c62-c8ece1f8278056
1876401dupilumab 300 MG in 2 ML Prefilled SyringePSN595f437d-2729-40bb-9c62-c8ece1f8278056
2583635DUPIXENT 100 MG in 0.67 ML Prefilled SyringePSN595f437d-2729-40bb-9c62-c8ece1f8278056
2559707DUPIXENT 200 MG in 1.14 ML Auto-InjectorPSN595f437d-2729-40bb-9c62-c8ece1f8278056
2099302DUPIXENT 200 MG in 1.14 mL Prefilled SyringePSN595f437d-2729-40bb-9c62-c8ece1f8278056
2375329DUPIXENT 300 MG in 2 ML Auto-InjectorPSN595f437d-2729-40bb-9c62-c8ece1f8278056
1876406DUPIXENT 300 MG in 2 ML Prefilled SyringePSN595f437d-2729-40bb-9c62-c8ece1f8278056
25836350.67 ML dupilumab 150 MG/ML Prefilled Syringe [Dupixent]SBD595f437d-2729-40bb-9c62-c8ece1f8278056
25597071.14 ML dupilumab 175 MG/ML Auto-Injector [Dupixent]SBD595f437d-2729-40bb-9c62-c8ece1f8278056
20993021.14 ML dupilumab 175 MG/ML Prefilled Syringe [Dupixent]SBD595f437d-2729-40bb-9c62-c8ece1f8278056
23753292 ML dupilumab 150 MG/ML Auto-Injector [Dupixent]SBD595f437d-2729-40bb-9c62-c8ece1f8278056
18764062 ML dupilumab 150 MG/ML Prefilled Syringe [Dupixent]SBD595f437d-2729-40bb-9c62-c8ece1f8278056
25836340.67 ML dupilumab 150 MG/ML Prefilled SyringeSCD595f437d-2729-40bb-9c62-c8ece1f8278056
25597061.14 ML dupilumab 175 MG/ML Auto-InjectorSCD595f437d-2729-40bb-9c62-c8ece1f8278056
20993001.14 ML dupilumab 175 MG/ML Prefilled SyringeSCD595f437d-2729-40bb-9c62-c8ece1f8278056
23753272 ML dupilumab 150 MG/ML Auto-InjectorSCD595f437d-2729-40bb-9c62-c8ece1f8278056
18764012 ML dupilumab 150 MG/ML Prefilled SyringeSCD595f437d-2729-40bb-9c62-c8ece1f8278056
25836350.67 ML Dupixent 150 MG/ML Prefilled SyringeSY595f437d-2729-40bb-9c62-c8ece1f8278056
20993021.14 ML Dupixent 175 MG/ML Prefilled SyringeSY595f437d-2729-40bb-9c62-c8ece1f8278056
23753292 ML Dupixent 150 MG/ML Auto-InjectorSY595f437d-2729-40bb-9c62-c8ece1f8278056
18764062 ML Dupixent 150 MG/ML Prefilled SyringeSY595f437d-2729-40bb-9c62-c8ece1f8278056
2559706dupilumab 175 MG/ML per 1.14 ML Auto-InjectorSY595f437d-2729-40bb-9c62-c8ece1f8278056
2559706dupilumab 200 MG per 1.14 ML Auto-InjectorSY595f437d-2729-40bb-9c62-c8ece1f8278056
2099300dupilumab 200 MG per 1.14 ML Prefilled SyringeSY595f437d-2729-40bb-9c62-c8ece1f8278056
2375327dupilumab 300 MG per 2 ML Auto-InjectorSY595f437d-2729-40bb-9c62-c8ece1f8278056
1876401dupilumab 300 MG per 2 ML Prefilled SyringeSY595f437d-2729-40bb-9c62-c8ece1f8278056
2583635Dupixent 100 MG per 0.67 ML Prefilled SyringeSY595f437d-2729-40bb-9c62-c8ece1f8278056
2559707Dupixent 175 MG/ML per 1.14 ML Auto-InjectorSY595f437d-2729-40bb-9c62-c8ece1f8278056
2559707Dupixent 200 MG per 1.14 ML Auto-InjectorSY595f437d-2729-40bb-9c62-c8ece1f8278056
2099302Dupixent 200 MG per 1.14 ML Prefilled SyringeSY595f437d-2729-40bb-9c62-c8ece1f8278056
2375329Dupixent 300 MG per 2 ML Auto-InjectorSY595f437d-2729-40bb-9c62-c8ece1f8278056
1876406Dupixent 300 MG per 2 ML Prefilled SyringeSY595f437d-2729-40bb-9c62-c8ece1f8278056

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0024-5915-00000245915002 mL in 1 SYRINGE, GLASS2 mlHistorical
0024-5915-01000245915012 mL in 1 SYRINGE, GLASS2 mlHistorical
0024-5915-02000245915022 SYRINGE, GLASS in 1 CARTON (0024-5915-02) / 2 mL in 1 SYRINGE, GLASS (0024-5915-00) 2020-06-190000-00-00NoNoCurrent
0024-5915-20000245915202 SYRINGE, GLASS in 1 CARTON (0024-5915-20) / 2 mL in 1 SYRINGE, GLASS (0024-5915-01) 2020-06-190000-00-00NoNoCurrent