FDA.reportPublic FDA data

cemiplimab-rwlc 350 MG per 7 ML Injection

RxCUI
2058830
RxNorm name
cemiplimab-rwlc 350 MG per 7 ML Injection
Display name
cemiplimab-rwlc 350 MG per 7 ML Injection
Full name
cemiplimab-rwlc 350 MG per 7 ML Injection
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:38:56

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761097Libtayocemiplimab-rwlc351(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.

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
4347ae1f-d397-4f18-8b70-03897e1c054acemiplimab-rwlc 350 MG in 7 ML Injection [PSN] · 7 ML cemiplimab-rwlc 50 MG/ML Injection [SCD] · cemiplimab-rwlc 350 MG per 7 ML Injection [SY] · cemiplimab-rwlc 50 MG/ML per 7 ML Injection [SY]423These highlights do not include all the information needed to use LIBTAYO safely and effectively. See full prescribing information for LIBTAYO. LIBTAYO ® (cemiplimab-rwlc) injection, for intravenous use Initial U.S. Approval: 201820251029