FDA.reportPublic FDA data

kisunla 350 MG in 20 ML Injection

RxCUI
2687979
RxNorm name
kisunla 350 MG in 20 ML Injection
Display name
kisunla 350 MG in 20 ML Injection
Full name
kisunla 350 MG in 20 ML Injection
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:38:48

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761248Kisunladonanemab-azbt351(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#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KisunlaDONANEMAB-AZBTEli Lilly and Company190352d4-ef62-4679-b4fa-e846e2766afa2025-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2687979

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
190352d4-ef62-4679-b4fa-e846e2766afakisunla 350 MG in 20 ML InjectionPSN8These highlights do not include all the information needed to use KISUNLA safely and effectively. See full prescribing information for KISUNLA. KISUNLA (donanemab-azbt) injection, for intravenous use Initial U.S. Approval: 202420251230
190352d4-ef62-4679-b4fa-e846e2766afaKisunla 350 MG per 20 ML InjectionSY8These highlights do not include all the information needed to use KISUNLA safely and effectively. See full prescribing information for KISUNLA. KISUNLA (donanemab-azbt) injection, for intravenous use Initial U.S. Approval: 202420251230
190352d4-ef62-4679-b4fa-e846e2766afa20 ML donanemab-azbt 17.5 MG/ML Injection [Kisunla]SBD8These highlights do not include all the information needed to use KISUNLA safely and effectively. See full prescribing information for KISUNLA. KISUNLA (donanemab-azbt) injection, for intravenous use Initial U.S. Approval: 202420251230