FDA.reportPublic FDA data

ecallantide 10 MG in 1 mL Injection

RxCUI
884698
RxNorm name
ecallantide 10 MG in 1 mL Injection
Display name
ecallantide 10 MG in 1 mL Injection
Full name
ecallantide 10 MG in 1 mL Injection
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:28

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125277Kalbitorecallantide351(a)Rx2026-09-01

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KalbitorECALLANTIDETakeda Pharmaceuticals America, Inc.f56aec67-c662-477c-b866-bfc23e8809cf2025-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 884698

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 IDRxNorm mappingsTermsSPL versionLabelEffective
f56aec67-c662-477c-b866-bfc23e8809cfecallantide 10 MG in 1 mL Injection [PSN] · 1 ML ecallantide 10 MG/ML Injection [SCD] · ecallantide 10 MG per 1 ML Injection [SY]319These highlights do not include all the information needed to use KALBITOR ® safely and effectively. See full prescribing information for KALBITOR. KALBITOR (ecallantide) injection, for subcutaneous use Initial U.S. Approval: 200920250701