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NDC 25682-0007-01 KANUMA 2 mg/mL Details
KANUMA 2 mg/mL
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 Information
| NDC | 25682-0007 |
|---|---|
| Product ID | 25682-007_5b55da2a-7a4d-435b-bf23-34a23e960a6d |
| Associated GPIs | 30906360002020 |
| GCN Sequence Number | 075069 |
| GCN Sequence Number Description | sebelipase alfa VIAL 20 MG/10ML INTRAVEN |
| HIC3 | Z1Q |
| HIC3 Description | METABOLIC DX ENZYME REPLACEMENT,LYSO.ACID LIP.DEF. |
| GCN | 39994 |
| HICL Sequence Number | 042747 |
| HICL Sequence Number Description | SEBELIPASE ALFA |
| Brand/Generic | Brand |
| Proprietary Name | KANUMA |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Sebelipase alfa |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION, CONCENTRATE |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 2 |
| Active Ingredient Units | mg/mL |
| Substance Name | SEBELIPASE ALFA |
| Labeler Name | Alexion Pharmaceuticals, Inc. |
| Pharmaceutical Class | Hydrolytic Lysosomal Cholesteryl Ester-specific Enzyme [EPC], Hydrolytic Lysosomal Triacylglycerol-specific Enzyme [EPC], Sterol Esterase [CS] |
| DEA Schedule | n/a |
| Marketing Category | BLA |
| Application Number | BLA125561 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 25682-0007-01 (25682000701)
| NDC Package Code | 25682-007-01 |
|---|---|
| Billing NDC | 25682000701 |
| Package | 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 |
| Pricing Information | N/A |