NDC 25682-007

KANUMA

Sebelipase Alfa

KANUMA is a Intravenous Injection, Solution, Concentrate in the Human Prescription Drug category. It is labeled and distributed by Alexion Pharmaceuticals, Inc.. The primary component is Sebelipase Alfa.

• Product ID: 25682-007_0d54fb95-62d6-401e-a06d-7bb13a443c88
• NDC: 25682-007
• Product Type: Human Prescription Drug
• Proprietary Name: KANUMA
• Generic Name: Sebelipase Alfa
• Dosage Form: Injection, Solution, Concentrate
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2015-12-08
• Marketing Category: BLA / BLA
• Application Number: BLA125561
• Labeler Name: Alexion Pharmaceuticals, Inc.
• Substance Name: SEBELIPASE ALFA
• Active Ingredient Strength: 2 mg/mL
• Pharm Classes: Hydrolytic Lysosomal Cholesteryl Ester-specific Enzyme [EPC],Hydrolytic Lysosomal Triacylglycerol-specific Enzyme [EPC],Sterol Esterase [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 25682-007-01

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

• Marketing Start Date: 2015-12-08
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 25682-007-01 [25682000701]

KANUMA INJECTION, SOLUTION, CONCENTRATE

• Marketing Category: BLA
• Application Number: BLA125561
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2015-12-08

Drug Details

Active Ingredients

Ingredient	Strength
SEBELIPASE ALFA	2 mg/mL

OpenFDA Data

• SPL SET ID: 83a77b9d-42f0-4645-8420-786285da7326
• Manufacturer:
  • Alexion Pharmaceuticals, Inc.
• UNII:
  • K4YTU42T8G
• RxNorm Concept Unique ID - RxCUI:
  • 1726984
  • 1726979

Pharmacological Class

• Hydrolytic Lysosomal Cholesteryl Ester-specific Enzyme [EPC]
• Hydrolytic Lysosomal Triacylglycerol-specific Enzyme [EPC]
• Sterol Esterase [CS]
• Hydrolytic Lysosomal Cholesteryl Ester-specific Enzyme [EPC]
• Hydrolytic Lysosomal Triacylglycerol-specific Enzyme [EPC]
• Sterol Esterase [CS]