FDA.reportPublic FDA data

2 ML dupilumab 150 MG/ML Auto-Injector [Dupixent]

RxCUI
2375329
RxNorm name
2 ML dupilumab 150 MG/ML Auto-Injector [Dupixent]
Display name
2 ML dupilumab 150 MG/ML Auto-Injector [Dupixent]
Full name
2 ML dupilumab 150 MG/ML Auto-Injector [Dupixent]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:38:59

Purple Book Biologic Products#

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

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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
rxcui: 2375329

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
595f437d-2729-40bb-9c62-c8ece1f827802 ML dupilumab 150 MG/ML Auto-Injector [Dupixent]SBD56These highlights do not include all the information needed to use DUPIXENT safely and effectively. See full prescribing information for DUPIXENT. DUPIXENT ® (dupilumab) injection, for subcutaneous use Initial U.S. Approval: 201720260422
595f437d-2729-40bb-9c62-c8ece1f82780DUPIXENT 300 MG in 2 ML Auto-InjectorPSN56These highlights do not include all the information needed to use DUPIXENT safely and effectively. See full prescribing information for DUPIXENT. DUPIXENT ® (dupilumab) injection, for subcutaneous use Initial U.S. Approval: 201720260422
595f437d-2729-40bb-9c62-c8ece1f82780Dupixent 300 MG per 2 ML Auto-InjectorSY56These highlights do not include all the information needed to use DUPIXENT safely and effectively. See full prescribing information for DUPIXENT. DUPIXENT ® (dupilumab) injection, for subcutaneous use Initial U.S. Approval: 201720260422
595f437d-2729-40bb-9c62-c8ece1f827802 ML Dupixent 150 MG/ML Auto-InjectorSY56These highlights do not include all the information needed to use DUPIXENT safely and effectively. See full prescribing information for DUPIXENT. DUPIXENT ® (dupilumab) injection, for subcutaneous use Initial U.S. Approval: 201720260422