FDA.reportPublic FDA data

5 ML dinutuximab 3.5 MG/ML Injection

RxCUI
1606278
RxNorm name
5 ML dinutuximab 3.5 MG/ML Injection
Display name
5 ML dinutuximab 3.5 MG/ML Injection
Full name
5 ML dinutuximab 3.5 MG/ML Injection
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:39:23

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125516Unituxindinutuximab351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
d66bdf0d-9d65-45de-ae5b-a58617c274925 ML dinutuximab 3.5 MG/ML InjectionSCD13These highlights do not include all the information needed to use UNITUXIN safely and effectively. See Full Prescribing Information for UNITUXIN. UNITUXIN ® (dinutuximab) injection, for intravenous use Initial U.S. Approval: 201520251021
d66bdf0d-9d65-45de-ae5b-a58617c27492dinutuximab 17.5 MG per 5 ML InjectionSY13These highlights do not include all the information needed to use UNITUXIN safely and effectively. See Full Prescribing Information for UNITUXIN. UNITUXIN ® (dinutuximab) injection, for intravenous use Initial U.S. Approval: 201520251021
d66bdf0d-9d65-45de-ae5b-a58617c27492dinutuximab 17.5 MG in 5 ML InjectionPSN13These highlights do not include all the information needed to use UNITUXIN safely and effectively. See Full Prescribing Information for UNITUXIN. UNITUXIN ® (dinutuximab) injection, for intravenous use Initial U.S. Approval: 201520251021