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
BLA	Proprietary name	Proper name	License type	Status	Latest source
761097	Libtayo	cemiplimab-rwlc	351(a)	Rx	2026-09-01

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LIBTAYO	CEMIPLIMAB-RWLC	Regeneron Pharmaceuticals, Inc.	4347ae1f-d397-4f18-8b70-03897e1c054a	2026-08-31	Warnings, Adverse reactions	Exact identifier rxcui: 2058830

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 ID	RxNorm mappings	Terms	SPL version	Label	Effective
4347ae1f-d397-4f18-8b70-03897e1c054a	cemiplimab-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]	4	23	These 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: 2018	20251029