FDA.reportPublic FDA data

Libtayo 350 MG per 7 ML Injection

RxCUI
2058835
RxNorm name
Libtayo 350 MG per 7 ML Injection
Display name
Libtayo 350 MG per 7 ML Injection
Full name
Libtayo 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)Rx2026-06-01

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
LIBTAYOCEMIPLIMAB-RWLCRegeneron Pharmaceuticals, Inc.4347ae1f-d397-4f18-8b70-03897e1c054a2025-10-29Warnings, Adverse reactionsExact identifier
rxcui: 2058835

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
4347ae1f-d397-4f18-8b70-03897e1c054aLibtayo 350 MG per 7 ML InjectionSY23These 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
4347ae1f-d397-4f18-8b70-03897e1c054aLIBTAYO 350 MG in 7 ML InjectionPSN23These 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
4347ae1f-d397-4f18-8b70-03897e1c054aLibtayo 50 MG/ML per 7 ML InjectionSY23These 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
4347ae1f-d397-4f18-8b70-03897e1c054a7 ML cemiplimab-rwlc 50 MG/ML Injection [Libtayo]SBD23These 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