FDA.reportPublic FDA data

donanemab-azbt 350 MG in 20 ML Injection

RxCUI
2687972
RxNorm name
donanemab-azbt 350 MG in 20 ML Injection
Display name
donanemab-azbt 350 MG in 20 ML Injection
Full name
donanemab-azbt 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: 2687972

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
190352d4-ef62-4679-b4fa-e846e2766afadonanemab-azbt 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-e846e2766afadonanemab-azbt 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 InjectionSCD8These 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