FDA.reportPublic FDA data

cosibelimab-ipdl 300 MG per 5 ML Injection

RxCUI
2717518
RxNorm name
cosibelimab-ipdl 300 MG per 5 ML Injection
Display name
cosibelimab-ipdl 300 MG per 5 ML Injection
Full name
cosibelimab-ipdl 300 MG per 5 ML Injection
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:38:46

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761297Unloxcytcosibelimab-ipdl351(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.

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
UNLOXCYTCOSIBELIMABSun Pharmaceutical Industries, Inc.06bdadd5-d2db-406f-a3f8-de47f48a52e32025-12-08Warnings, Adverse reactionsExact identifier
rxcui: 2717518

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
06bdadd5-d2db-406f-a3f8-de47f48a52e3cosibelimab-ipdl 300 MG in 5 ML Injection [PSN] · 5 ML cosibelimab-ipdl 60 MG/ML Injection [SCD] · cosibelimab-ipdl 300 MG per 5 ML Injection [SY] · cosibelimab-ipdl 60 MG/ML per 5 ML Injection [SY]43These highlights do not include all the information needed to use UNLOXCYT safely and effectively. See full prescribing information for UNLOXCYT. UNLOXCYT (cosibelimab-ipdl) injection, for intravenous use Initial U.S. Approval: 202420251208