kanuma

Generic: sebelipase alfa

Labeler: alexion pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name kanuma
Generic Name sebelipase alfa
Labeler alexion pharmaceuticals, inc.
Dosage Form INJECTION, SOLUTION, CONCENTRATE
Routes
INTRAVENOUS
Active Ingredients

sebelipase alfa 2 mg/mL

Manufacturer
Alexion Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 25682-007
Product ID 25682-007_341de317-904b-4933-88da-b239c5989871
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA125561
Listing Expiration 2026-12-31
Marketing Start 2015-12-08

Pharmacologic Class

Established (EPC)
hydrolytic lysosomal cholesteryl ester-specific enzyme [epc] hydrolytic lysosomal triacylglycerol-specific enzyme [epc]
Chemical Structure
sterol esterase [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 25682007
Hyphenated Format 25682-007

Supplemental Identifiers

RxCUI
1726979 1726984
UNII
K4YTU42T8G
NUI
N0000192342 N0000192343 M0004273

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name kanuma (source: ndc)
Generic Name sebelipase alfa (source: ndc)
Application Number BLA125561 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 1 VIAL, GLASS in 1 CARTON (25682-007-01) / 10 mL in 1 VIAL, GLASS
source: ndc

Packages (1)

25682-007-01 1 VIAL, GLASS in 1 CARTON (25682-007-01) / 10 mL in 1 VIAL, GLASS

Ingredients (1)

sebelipase alfa (2 mg/mL)

Linked Drug Pages (1)

KANUMA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "341de317-904b-4933-88da-b239c5989871", "openfda": {"nui": ["N0000192342", "N0000192343", "M0004273"], "unii": ["K4YTU42T8G"], "rxcui": ["1726979", "1726984"], "spl_set_id": ["83a77b9d-42f0-4645-8420-786285da7326"], "pharm_class_cs": ["Sterol Esterase [CS]"], "pharm_class_epc": ["Hydrolytic Lysosomal Cholesteryl Ester-specific Enzyme [EPC]", "Hydrolytic Lysosomal Triacylglycerol-specific Enzyme [EPC]"], "manufacturer_name": ["Alexion Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 CARTON (25682-007-01)  / 10 mL in 1 VIAL, GLASS", "package_ndc": "25682-007-01", "marketing_start_date": "20151208"}], "brand_name": "KANUMA", "product_id": "25682-007_341de317-904b-4933-88da-b239c5989871", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "pharm_class": ["Hydrolytic Lysosomal Cholesteryl Ester-specific Enzyme [EPC]", "Hydrolytic Lysosomal Triacylglycerol-specific Enzyme [EPC]", "Sterol Esterase [CS]"], "product_ndc": "25682-007", "generic_name": "Sebelipase alfa", "labeler_name": "Alexion Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "KANUMA", "active_ingredients": [{"name": "SEBELIPASE ALFA", "strength": "2 mg/mL"}], "application_number": "BLA125561", "marketing_category": "BLA", "marketing_start_date": "20151208", "listing_expiration_date": "20261231"}