NDC 68135-927-01 - ROCTAVIAN
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
- 68135-927
- Requested NDC
- 68135-927-01
- Package NDCs from labels
- 68135-927-01, 68135-927-48
- Manufacturer
- BioMarin Pharmaceutical Inc.
- Effective date
- 2023-06-29
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| ROCTAVIAN - BioMarin Pharmaceutical Inc. | BioMarin Pharmaceutical Inc. | 2023-06-29 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68135-927-01 | ROCTAVIAN | 8 mL in 1 VIAL | INJECTION, SUSPENSION | 8 | 20 | |
| 68135-927-48 | ROCTAVIAN | 1 in 1 CARTON | INJECTION, SUSPENSION | 1 | 20 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68135-927-01 | EA - Each | 68135-927 | d9934110-7a43-4805-ada8-c26c6d0f9da7 | 1 | 2023-08-08 |
| 68135-927-48 | EA - Each | 68135-927 | 7b280f62-6804-4a96-942b-db7ab89167a1 | 1 | 2023-08-08 |
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 |
|---|---|---|---|---|---|---|
| d4718224-ef93-408b-96e7-d72ce195527b | 0dcf7185-8e1c-456a-9d4e-7cc316400118 | 2023-06-29 | Warnings, Adverse reactions | 0dcf7185-8e1c-456a-9d4e-7cc316400118 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.