FDA.reportPublic FDA data

NDC 68135-495 - 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
68135-495
Package NDCs from labels
68135-495-04
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 Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68135-495BRINEURA (CERLIPONASE ALFA) KIT [BIOMARIN PHARMACEUTICAL INC.]30Unmatched20240808_485ab3c5-0359-4878-872f-2fe1e7df4047.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 ยท 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BrineuraCERLIPONASE ALFABioMarin Pharmaceutical Inc.485ab3c5-0359-4878-872f-2fe1e7df40472024-08-05Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761052
ndc (package): 68135-500-00
ndc (package): 68135-495-04
ndc (package): 68135-811-02
ndc (product): 68135-811
rxcui: 1922458
rxcui: 1922453
spl id: 1ebeb049-90ec-42ff-9361-b6fa38d79515
spl set id: 485ab3c5-0359-4878-872f-2fe1e7df4047

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.