FDA.reportPublic FDA data

Dupixent

Product NDC
0024-5919
11-digit product format
000245919
Labeler code
0024
Product ID
0024-5919_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
2021-06-14
Substance
DUPILUMAB
Active strength
200 mg/1.14mL
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
DUPILUMAB200 mg/1.14mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
420K487FSGInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1876401Internal RxNorm lookup
1876406Internal RxNorm lookup
2099300Internal RxNorm lookup
2099302Internal RxNorm lookup
2375327Internal RxNorm lookup
2375329Internal RxNorm lookup
2559706Internal RxNorm lookup
2559707Internal RxNorm lookup
2583634Internal RxNorm lookup
2583635Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
595f437d-2729-40bb-9c62-c8ece1f82780Available on FDA.report

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
0024-5919-00Dupixent1.14 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION1.1456
0024-5919-01Dupixent1.14 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION1.1456
0024-5919-02Dupixent2 in 1 CARTONINJECTION, SOLUTION256
0024-5919-20Dupixent2 in 1 CARTONINJECTION, SOLUTION256

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0024-5919-00ML - Milliliter0024-5919d4a12446-32a4-41df-8b0d-85503c2519b312021-07-15
0024-5919-01ML - Milliliter0024-59197478c771-0ea8-472d-a37a-cc8f7fcfe7fa12021-07-15
0024-5919-02ML - Milliliter0024-5919b0c40789-8004-4734-ab12-0dc762ff56cf12021-07-15
0024-5919-20ML - Milliliter0024-591921e6d510-2f50-40b7-a674-0ec66564885012021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0024-5919DUPIXENT (DUPILUMAB) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC]46Current NDC, Legacy NDC, 4 package rows20250429_595f437d-2729-40bb-9c62-c8ece1f82780.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DupixentDUPILUMABSanofi-Aventis U.S. LLC595f437d-2729-40bb-9c62-c8ece1f827802026-04-22Warnings, Adverse reactionsExact identifier
application number: BLA761055
ndc (product): 0024-5919

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761055Dupixentdupilumab351(a)Rx2026-06-01

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
0024-5919-00000245919001.14 mL in 1 SYRINGE, GLASS1.14 mlHistorical
0024-5919-01000245919011.14 mL in 1 SYRINGE, GLASS1.14 mlHistorical
0024-5919-02000245919022 SYRINGE, GLASS in 1 CARTON (0024-5919-02) / 1.14 mL in 1 SYRINGE, GLASS (0024-5919-00) 2021-06-140000-00-00NoNoCurrent
0024-5919-20000245919202 SYRINGE, GLASS in 1 CARTON (0024-5919-20) / 1.14 mL in 1 SYRINGE, GLASS (0024-5919-01) 2021-06-140000-00-00NoNoCurrent