Dupixent

Product NDC: 0024-5916
Requested package NDC: 0024-5916-01
11-digit product format: 000245916
Labeler code: 0024
Product ID: 0024-5916_ed234fa7-9084-4b79-ae02-66abe58043f3
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: 2017-03-28
Marketing end: 0000-00-00
Substance: DUPILUMAB
Active strength: 300 mg/2mL
Pharmacologic classes: Interleukin-4 Receptor alpha Antagonist [EPC],Interleukin 4 Receptor alpha Antagonists [MoA],Antibodies, Monoclonal [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

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	0024-5916	0024-5916-01	D	Discontinued by firm		2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0024-5916-01	00024591601	2 SYRINGE, GLASS in 1 CARTON (0024-5916-01) > 2 mL in 1 SYRINGE, GLASS	2017-03-28	0000-00-00	No	No	Current