FDA.reportPublic FDA data

Kisunla

Product NDC
0002-9401
Requested package NDC
0002-9401-01
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

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

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
KisunlaDONANEMAB-AZBTEli Lilly and Company190352d4-ef62-4679-b4fa-e846e2766afa2025-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761248
ndc (package): 0002-9401-01
ndc (product): 0002-9401
ndc11 (package): 00002940101

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761248Kisunladonanemab-azbt351(a)Rx2026-08-01

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