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)Rx2026-06-01
761122Nucalamepolizumab351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
fefb887c-e4ac-431e-8893-e9d1a5a63fea0.4 ML mepolizumab 100 MG/ML Prefilled Syringe [Nucala]SBD24These 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
fefb887c-e4ac-431e-8893-e9d1a5a63feaNucala 40 MG per 0.4 ML Prefilled SyringeSY24These 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
fefb887c-e4ac-431e-8893-e9d1a5a63fea0.4 ML Nucala 100 MG/ML Prefilled SyringeSY24These 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
fefb887c-e4ac-431e-8893-e9d1a5a63feaNucala 40 MG in 0.4 ML Prefilled SyringePSN24These 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