FDA.reportPublic FDA data

0.4 ML mepolizumab 100 MG/ML Prefilled Syringe [Nucala]

RxCUI
2596445
RxNorm name
0.4 ML mepolizumab 100 MG/ML Prefilled Syringe [Nucala]
Display name
0.4 ML mepolizumab 100 MG/ML Prefilled Syringe [Nucala]
Full name
0.4 ML mepolizumab 100 MG/ML Prefilled Syringe [Nucala]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:39:30

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125526Nucalamepolizumab351(a)Rx2026-07-01
761122Nucalamepolizumab351(a)Rx2026-07-01

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
NucalaMEPOLIZUMABGlaxoSmithKline LLCfefb887c-e4ac-431e-8893-e9d1a5a63fea2025-08-06Warnings, Adverse reactionsExact identifier
rxcui: 2596445

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
fefb887c-e4ac-431e-8893-e9d1a5a63feaNucala 40 MG in 0.4 ML Prefilled Syringe [PSN] · 0.4 ML mepolizumab 100 MG/ML Prefilled Syringe [Nucala] [SBD] · 0.4 ML Nucala 100 MG/ML Prefilled Syringe [SY] · Nucala 40 MG per 0.4 ML Prefilled Syringe [SY]424These highlights do not include all the information needed to use NUCALA safely and effectively. See full prescribing information for NUCALA. NUCALA (mepolizumab) for injection, for subcutaneous use NUCALA (mepolizumab) injection, for subcutaneous use Initial U.S. Approval: 201520250806