FDA.reportPublic FDA data

NDC 68135-500 - Brineura

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
68135-500
Package NDCs from labels
68135-500-00
Manufacturer
BioMarin Pharmaceutical Inc. | Almac Pharma Services (Ireland) Limited
Effective date
2024-08-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Brineura - BioMarin Pharmaceutical Inc. | Almac Pharma Services (Ireland) LimitedBioMarin Pharmaceutical Inc. | Almac Pharma Services (Ireland) Limited2024-08-05HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68135-500-00Brineura5 mL in 1 VIAL, GLASSINJECTION, SOLUTION10 mL150 mg in 5mL30

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68135-500BRINEURA (CERLIPONASE ALFA) KIT [BIOMARIN PHARMACEUTICAL INC.]30Unmatched20240808_485ab3c5-0359-4878-872f-2fe1e7df4047.zip