KANUMA

Product NDC: 25682-007
Requested package NDC: 25682-007-01
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	25682-007	25682-007-01	I	Inactivated by FDA		2026-08-10

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c32377c0-013b-4d9f-aa91-1267ea5fdb00	Product name	1	20160111

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
25682-007-01	2020-08-21	C162847	48780-1	ab0e2407-3527-f274-e053-dbdaa90a6471	These 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
25682-007-01	2020-07-22	C162847	48780-1	ab0e2407-3527-f274-e053-dbdaa90a6471	These 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

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
25682-007-01	KANUMA	10 mL in 1 VIAL, GLASS	INJECTION, SOLUTION, CONCENTRATE	10		11
25682-007-01	KANUMA	1 in 1 CARTON	INJECTION, SOLUTION, CONCENTRATE	1		11

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
25682-007-01	ML - Milliliter	25682-007	757985f0-c4d3-4be7-8357-855ff5bf44f6	1	2016-01-13

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
25682-007	KANUMA (SEBELIPASE ALFA) INJECTION, SOLUTION, CONCENTRATE [ALEXION PHARMACEUTICALS, INC.]	10	Current NDC, Legacy NDC, 2 package rows	20240719_83a77b9d-42f0-4645-8420-786285da7326.zip

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
125561	Kanuma	sebelipase alfa	351(a)	Rx	2026-06-01

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
K4YTU42T8G	SEBELIPASE ALFA	1276027-63-4	SEBELIPASE ALFA

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1726984	Kanuma 20 MG in 10 ML Injection	PSN	83a77b9d-42f0-4645-8420-786285da7326	11
1726979	sebelipase alfa 20 MG in 10 ML Injection	PSN	83a77b9d-42f0-4645-8420-786285da7326	11
1726984	10 ML sebelipase alfa 2 MG/ML Injection [Kanuma]	SBD	83a77b9d-42f0-4645-8420-786285da7326	11
1726979	10 ML sebelipase alfa 2 MG/ML Injection	SCD	83a77b9d-42f0-4645-8420-786285da7326	11
1726984	10 ML Kanuma 2 MG/ML Injection	SY	83a77b9d-42f0-4645-8420-786285da7326	11
1726984	Kanuma 20 MG per 10 ML Injection	SY	83a77b9d-42f0-4645-8420-786285da7326	11
1726979	sebelipase alfa 20 MG per 10 ML Injection	SY	83a77b9d-42f0-4645-8420-786285da7326	11

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
25682-007-01	25682000701	1 VIAL, GLASS in 1 CARTON (25682-007-01) / 10 mL in 1 VIAL, GLASS	2015-12-08	0000-00-00	No	No	Current