FDA.reportPublic FDA data

0.5 ML nirsevimab-alip 100 MG/ML Prefilled Syringe

RxCUI
2642406
RxNorm name
0.5 ML nirsevimab-alip 100 MG/ML Prefilled Syringe
Display name
0.5 ML nirsevimab-alip 100 MG/ML Prefilled Syringe
Full name
0.5 ML nirsevimab-alip 100 MG/ML Prefilled Syringe
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:38:52

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761328Beyfortusnirsevimab-alip351(a)Rx2026-08-01

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
BEYFORTUSNIRSEVIMABSanofi Vaccines US Inc.2f08fa60-f674-432d-801b-1f9514bd9b392026-06-26Warnings, Adverse reactionsExact identifier
rxcui: 2642406

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
2f08fa60-f674-432d-801b-1f9514bd9b39nirsevimab-alip 50 MG in 0.5 ML Prefilled Syringe [PSN] · 0.5 ML nirsevimab-alip 100 MG/ML Prefilled Syringe [SCD] · nirsevimab-alip 50 MG per 0.5 ML Prefilled Syringe [SY]326These highlights do not include all the information needed to use BEYFORTUS ® safely and effectively. See full prescribing information for BEYFORTUS. BEYFORTUS (nirsevimab-alip) injection, for intramuscular use Initial U.S. Approval: 202320260428