Dupixent

Product NDC: 0024-5911
Requested package NDC: 0024-5911-02
11-digit product format: 000245911
Labeler code: 0024
Product ID: 0024-5911_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: 2021-10-20
Substance: DUPILUMAB
Active strength: 100 mg/.67mL
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0024-5911	0024-5911-02	D	Discontinued by firm		2026-08-10

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
5e742946-05d0-4c58-8341-b0f3b1387bd3	Product name	2	20220118
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
1681bc73-b05f-12c3-1075-382ae39f449c	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0024-5911-00	Dupixent	0.67 mL in 1 SYRINGE, GLASS	INJECTION, SOLUTION	0.67	56
0024-5911-01	Dupixent	0.67 mL in 1 SYRINGE, GLASS	INJECTION, SOLUTION	0.67	56
0024-5911-02	Dupixent	2 in 1 CARTON	INJECTION, SOLUTION	2	56
0024-5911-20	Dupixent	2 in 1 CARTON	INJECTION, SOLUTION	2	56

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0024-5911-00	ML - Milliliter	0024-5911	dcbc0d4a-3d4e-49a8-bcd7-aa90faefb328	1	2021-11-09
0024-5911-02	ML - Milliliter	0024-5911	0819ecca-38d3-4df8-bdbf-b9c1d784831f	1	2021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0024-5911	DUPIXENT (DUPILUMAB) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC]	46	Current NDC, Legacy NDC, 4 package rows	20250429_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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dupixent	DUPILUMAB	Sanofi-Aventis U.S. LLC	595f437d-2729-40bb-9c62-c8ece1f82780	2026-04-22	Warnings, Adverse reactions	Exact identifier application number: BLA761055

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
761055	Dupixent	dupilumab	351(a)	Rx	2026-06-01

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
420K487FSG	DUPILUMAB	1190264-60-8	DUPILUMAB

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2583634	dupilumab 100 MG in 0.67 ML Prefilled Syringe	PSN	595f437d-2729-40bb-9c62-c8ece1f82780	56
2559706	dupilumab 200 MG in 1.14 ML Auto-Injector	PSN	595f437d-2729-40bb-9c62-c8ece1f82780	56
2099300	dupilumab 200 MG in 1.14 mL Prefilled Syringe	PSN	595f437d-2729-40bb-9c62-c8ece1f82780	56
2375327	dupilumab 300 MG in 2 ML Auto-Injector	PSN	595f437d-2729-40bb-9c62-c8ece1f82780	56
1876401	dupilumab 300 MG in 2 ML Prefilled Syringe	PSN	595f437d-2729-40bb-9c62-c8ece1f82780	56
2583635	DUPIXENT 100 MG in 0.67 ML Prefilled Syringe	PSN	595f437d-2729-40bb-9c62-c8ece1f82780	56
2559707	DUPIXENT 200 MG in 1.14 ML Auto-Injector	PSN	595f437d-2729-40bb-9c62-c8ece1f82780	56
2099302	DUPIXENT 200 MG in 1.14 mL Prefilled Syringe	PSN	595f437d-2729-40bb-9c62-c8ece1f82780	56
2375329	DUPIXENT 300 MG in 2 ML Auto-Injector	PSN	595f437d-2729-40bb-9c62-c8ece1f82780	56
1876406	DUPIXENT 300 MG in 2 ML Prefilled Syringe	PSN	595f437d-2729-40bb-9c62-c8ece1f82780	56
2583635	0.67 ML dupilumab 150 MG/ML Prefilled Syringe [Dupixent]	SBD	595f437d-2729-40bb-9c62-c8ece1f82780	56
2559707	1.14 ML dupilumab 175 MG/ML Auto-Injector [Dupixent]	SBD	595f437d-2729-40bb-9c62-c8ece1f82780	56
2099302	1.14 ML dupilumab 175 MG/ML Prefilled Syringe [Dupixent]	SBD	595f437d-2729-40bb-9c62-c8ece1f82780	56
2375329	2 ML dupilumab 150 MG/ML Auto-Injector [Dupixent]	SBD	595f437d-2729-40bb-9c62-c8ece1f82780	56
1876406	2 ML dupilumab 150 MG/ML Prefilled Syringe [Dupixent]	SBD	595f437d-2729-40bb-9c62-c8ece1f82780	56
2583634	0.67 ML dupilumab 150 MG/ML Prefilled Syringe	SCD	595f437d-2729-40bb-9c62-c8ece1f82780	56
2559706	1.14 ML dupilumab 175 MG/ML Auto-Injector	SCD	595f437d-2729-40bb-9c62-c8ece1f82780	56
2099300	1.14 ML dupilumab 175 MG/ML Prefilled Syringe	SCD	595f437d-2729-40bb-9c62-c8ece1f82780	56
2375327	2 ML dupilumab 150 MG/ML Auto-Injector	SCD	595f437d-2729-40bb-9c62-c8ece1f82780	56
1876401	2 ML dupilumab 150 MG/ML Prefilled Syringe	SCD	595f437d-2729-40bb-9c62-c8ece1f82780	56
2583635	0.67 ML Dupixent 150 MG/ML Prefilled Syringe	SY	595f437d-2729-40bb-9c62-c8ece1f82780	56
2099302	1.14 ML Dupixent 175 MG/ML Prefilled Syringe	SY	595f437d-2729-40bb-9c62-c8ece1f82780	56
2375329	2 ML Dupixent 150 MG/ML Auto-Injector	SY	595f437d-2729-40bb-9c62-c8ece1f82780	56
1876406	2 ML Dupixent 150 MG/ML Prefilled Syringe	SY	595f437d-2729-40bb-9c62-c8ece1f82780	56
2559706	dupilumab 175 MG/ML per 1.14 ML Auto-Injector	SY	595f437d-2729-40bb-9c62-c8ece1f82780	56
2559706	dupilumab 200 MG per 1.14 ML Auto-Injector	SY	595f437d-2729-40bb-9c62-c8ece1f82780	56
2099300	dupilumab 200 MG per 1.14 ML Prefilled Syringe	SY	595f437d-2729-40bb-9c62-c8ece1f82780	56
2375327	dupilumab 300 MG per 2 ML Auto-Injector	SY	595f437d-2729-40bb-9c62-c8ece1f82780	56
1876401	dupilumab 300 MG per 2 ML Prefilled Syringe	SY	595f437d-2729-40bb-9c62-c8ece1f82780	56
2583635	Dupixent 100 MG per 0.67 ML Prefilled Syringe	SY	595f437d-2729-40bb-9c62-c8ece1f82780	56
2559707	Dupixent 175 MG/ML per 1.14 ML Auto-Injector	SY	595f437d-2729-40bb-9c62-c8ece1f82780	56
2559707	Dupixent 200 MG per 1.14 ML Auto-Injector	SY	595f437d-2729-40bb-9c62-c8ece1f82780	56
2099302	Dupixent 200 MG per 1.14 ML Prefilled Syringe	SY	595f437d-2729-40bb-9c62-c8ece1f82780	56
2375329	Dupixent 300 MG per 2 ML Auto-Injector	SY	595f437d-2729-40bb-9c62-c8ece1f82780	56
1876406	Dupixent 300 MG per 2 ML Prefilled Syringe	SY	595f437d-2729-40bb-9c62-c8ece1f82780	56

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0024-5911-02	00024591102	2 SYRINGE, GLASS in 1 CARTON (0024-5911-02) / .67 mL in 1 SYRINGE, GLASS (0024-5911-00)	2021-10-20	2026-07-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dupixent	Sanofi-Aventis U.S. LLC \| Regeneron Pharmaceuticals, Inc. \| Sanofi Winthrop Industrie \| Sanofi-Aventis Deutschland GmbH \| Genzyme Ireland Limited \| Regeneron Ireland Designated Activity Company	2026-04-22	HUMAN PRESCRIPTION DRUG LABEL	60