FDA.reportPublic FDA data

loncastuximab tesirine-lpyl 10 MG Injection [Zynlonta]

RxCUI
2540974
RxNorm name
loncastuximab tesirine-lpyl 10 MG Injection [Zynlonta]
Display name
loncastuximab tesirine-lpyl 10 MG Injection [Zynlonta]
Full name
loncastuximab tesirine-lpyl 10 MG Injection [Zynlonta]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:39:16

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761196Zynlontaloncastuximab tesirine-lpyl351(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
ZYNLONTALONCASTUXIMAB TESIRINEADC Therapeutics America, Inc.af54af12-3edf-4301-8bc5-0446bc813c1d2026-06-12Warnings, Adverse reactionsExact identifier
rxcui: 2540974

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
af54af12-3edf-4301-8bc5-0446bc813c1dZynlonta 10 MG Injection [PSN] · loncastuximab tesirine-lpyl 10 MG Injection [Zynlonta] [SBD] · Zynlonta 10 MG Injection [SY]314These highlights do not include all the information needed to use ZYNLONTA safely and effectively. See full prescribing information for ZYNLONTA. ZYNLONTA ® (loncastuximab tesirine-lpyl) for injection, for intravenous use Initial U.S. Approval: 202120260226