Fabrazyme 35 MG Injection
- RxCUI
- 1804758
- RxNorm name
- Fabrazyme 35 MG Injection
- Display name
- Fabrazyme 35 MG Injection
- Full name
- Fabrazyme 35 MG Injection
- Term type
- SY
- Status
- DailyMed mapping
- Updated
- 2026-06-04 23:39:09
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 103979 | Fabrazyme | agalsidase beta | 351(a) | Rx | 2026-06-01 |
UNII Substances#
No records found.
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 |
|---|---|---|---|---|---|---|
| Fabrazyme | AGALSIDASE BETA | Genzyme Corporation | 988513ab-b06f-4dd0-93f7-d2d4531dcce4 | 2025-08-22 | Boxed warning, Warnings, Adverse reactions | 1804758 |
DailyMed RxNorm Mappings#
| Set ID | RxNorm string | TTY | SPL version | Label | Effective |
|---|---|---|---|---|---|
| 988513ab-b06f-4dd0-93f7-d2d4531dcce4 | Fabrazyme 35 MG Injection | SY | 35 | These highlights do not include all the information needed to use FABRAZYME ® safely and effectively. See full prescribing information for FABRAZYME ® . FABRAZYME ® (agalsidase beta) for injection, for intravenous use Initial U.S. Approval: 2003 | 20250822 |
| 988513ab-b06f-4dd0-93f7-d2d4531dcce4 | Fabrazyme 35 MG Injection | PSN | 35 | These highlights do not include all the information needed to use FABRAZYME ® safely and effectively. See full prescribing information for FABRAZYME ® . FABRAZYME ® (agalsidase beta) for injection, for intravenous use Initial U.S. Approval: 2003 | 20250822 |
| 988513ab-b06f-4dd0-93f7-d2d4531dcce4 | agalsidase beta 35 MG Injection [Fabrazyme] | SBD | 35 | These highlights do not include all the information needed to use FABRAZYME ® safely and effectively. See full prescribing information for FABRAZYME ® . FABRAZYME ® (agalsidase beta) for injection, for intravenous use Initial U.S. Approval: 2003 | 20250822 |