FDA.reportPublic FDA data

Kisunla

Product NDC
0002-9401
11-digit product format
000029401
Labeler code
0002
Product ID
0002-9401_85d3d68b-57f9-45e6-a1a7-fa19bc843f33
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
donanemab-azbt
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Eli Lilly and Company
Application
BLA761248
Marketing category
BLA
Marketing start
2024-07-02
Substance
DONANEMAB
Active strength
17.5 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
application number: BLA761248
ndc (product): 0002-9401

Additional Listing Data#

Finished product
Yes
Brand name base
Kisunla
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DONANEMAB17.5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1ADB65P1KKInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2687972Internal RxNorm lookup
2687979Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
190352d4-ef62-4679-b4fa-e846e2766afaAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cf3f5efd-dd25-4b40-9eb0-4dcdd56fcfaaProduct name120250305
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0002-9401-01Kisunla1 in 1 CARTONINJECTION, SOLUTION18
0002-9401-01Kisunla20 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION208

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0002-9401-01ML - Milliliter0002-9401e7b72cf1-9921-47e6-9094-14c140e3911b12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0002-9401KISUNLA (DONANEMAB-AZBT) INJECTION, SOLUTION [ELI LILLY AND COMPANY]4Current NDC, 2 package rows20240713_190352d4-ef62-4679-b4fa-e846e2766afa.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761248Kisunladonanemab-azbt351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2687972donanemab-azbt 350 MG in 20 ML InjectionPSN190352d4-ef62-4679-b4fa-e846e2766afa8
2687979kisunla 350 MG in 20 ML InjectionPSN190352d4-ef62-4679-b4fa-e846e2766afa8
268797920 ML donanemab-azbt 17.5 MG/ML Injection [Kisunla]SBD190352d4-ef62-4679-b4fa-e846e2766afa8
268797220 ML donanemab-azbt 17.5 MG/ML InjectionSCD190352d4-ef62-4679-b4fa-e846e2766afa8
2687972donanemab-azbt 350 MG per 20 ML InjectionSY190352d4-ef62-4679-b4fa-e846e2766afa8
2687979Kisunla 350 MG per 20 ML InjectionSY190352d4-ef62-4679-b4fa-e846e2766afa8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0002-9401-01000029401011 VIAL, SINGLE-DOSE in 1 CARTON (0002-9401-01) / 20 mL in 1 VIAL, SINGLE-DOSE2024-07-02NoNoCurrent