FDA.reportPublic FDA data

KANUMA

Product NDC
25682-007
11-digit product format
256820007
Labeler code
25682
Product ID
25682-007_341de317-904b-4933-88da-b239c5989871
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sebelipase alfa
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Alexion Pharmaceuticals, Inc.
Application
BLA125561
Marketing category
BLA
Marketing start
2015-12-08
Substance
SEBELIPASE ALFA
Active strength
2 mg/mL
Pharmacologic classes
Hydrolytic Lysosomal Cholesteryl Ester-specific Enzyme [EPC], Hydrolytic Lysosomal Triacylglycerol-specific Enzyme [EPC], Sterol Esterase [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SEBELIPASE ALFA2 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiK4YTU42T8G
Rxcui1726979, 1726984

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c32377c0-013b-4d9f-aa91-1267ea5fdb00Product name120160111

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
25682-007-012020-08-21C16284748780-1ab0e2407-3527-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use KANUMA safely and effectively. See full prescribing information for KANUMA. KANUMA (sebelipase alfa) injection, for intravenous use Initial U.S. Approval: 2015
25682-007-012020-07-22C16284748780-1ab0e2407-3527-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use KANUMA safely and effectively. See full prescribing information for KANUMA. KANUMA (sebelipase alfa) injection, for intravenous use Initial U.S. Approval: 2015

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
25682-007-01KANUMA10 mL in 1 VIAL, GLASSINJECTION, SOLUTION, CONCENTRATE1011
25682-007-01KANUMA1 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25682-007-01ML - Milliliter25682-007757985f0-c4d3-4be7-8357-855ff5bf44f612016-01-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25682-007KANUMA (SEBELIPASE ALFA) INJECTION, SOLUTION, CONCENTRATE [ALEXION PHARMACEUTICALS, INC.]10Current NDC, Legacy NDC, 2 package rows20240719_83a77b9d-42f0-4645-8420-786285da7326.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1726984Kanuma 20 MG in 10 ML InjectionPSN83a77b9d-42f0-4645-8420-786285da732611
1726979sebelipase alfa 20 MG in 10 ML InjectionPSN83a77b9d-42f0-4645-8420-786285da732611
172698410 ML sebelipase alfa 2 MG/ML Injection [Kanuma]SBD83a77b9d-42f0-4645-8420-786285da732611
172697910 ML sebelipase alfa 2 MG/ML InjectionSCD83a77b9d-42f0-4645-8420-786285da732611
172698410 ML Kanuma 2 MG/ML InjectionSY83a77b9d-42f0-4645-8420-786285da732611
1726984Kanuma 20 MG per 10 ML InjectionSY83a77b9d-42f0-4645-8420-786285da732611
1726979sebelipase alfa 20 MG per 10 ML InjectionSY83a77b9d-42f0-4645-8420-786285da732611

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
25682-007-01256820007011 VIAL, GLASS in 1 CARTON (25682-007-01) / 10 mL in 1 VIAL, GLASS2015-12-080000-00-00NoNoCurrent