FDA.reportPublic FDA data

NDC 58468-0227 - Cablivi

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
58468-0227
Package NDCs from labels
58468-0227-1
Manufacturer
Genzyme Corporation | Richter Helm Biologics GmbH and Co KG (Bovenau) | Richter Helm Biologics GmbH and Co KG (Hamburg) | Patheon Italia S.p.A. | Ablynx | Enestia Belgium NV (trading as Sharp Packaging Solutions)
Effective date
2026-04-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
CabliviGenzyme Corporation | Richter Helm Biologics GmbH and Co KG (Bovenau) | Richter Helm Biologics GmbH and Co KG (Hamburg) | Patheon Italia S.p.A. | Ablynx | Enestia Belgium NV (trading as Sharp Packaging Solutions)2026-04-24HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58468-0227-1Cablivi1 mL in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,1 mL11 mg in 1mL18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58468-0227CABLIVI (CAPLACIZUMAB) KIT [GENZYME CORPORATION]14Unmatched20241108_2348f06e-8004-4040-832e-e9e86a39f905.zip