NDC 68135-495-04 - 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
- Requested NDC
- 68135-495-04
- 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 | Type |
|---|---|---|---|
| Brineura - BioMarin Pharmaceutical Inc. | Almac Pharma Services (Ireland) Limited | BioMarin Pharmaceutical Inc. | Almac Pharma Services (Ireland) Limited | 2024-08-05 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Dashboard NDC Coverage#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Brineura | CERLIPONASE ALFA | BioMarin Pharmaceutical Inc. | 485ab3c5-0359-4878-872f-2fe1e7df4047 | 2024-08-05 | Boxed warning, Warnings, Adverse reactions | BLA761052 68135-500-00 68135-495-04 68135-811-02 68135-811 68135049504 1922458 1922453 1ebeb049-90ec-42ff-9361-b6fa38d79515 485ab3c5-0359-4878-872f-2fe1e7df4047 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.