25 ML isatuximab-irfc 20 MG/ML Injection [Sarclisa]
- RxCUI
- 2282032
- RxNorm name
- 25 ML isatuximab-irfc 20 MG/ML Injection [Sarclisa]
- Display name
- 25 ML isatuximab-irfc 20 MG/ML Injection [Sarclisa]
- Full name
- 25 ML isatuximab-irfc 20 MG/ML Injection [Sarclisa]
- Term type
- SBD
- Status
- DailyMed mapping
- Updated
- 2026-06-04 23:39:11
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761113 | Sarclisa | isatuximab-irfc | 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 |
|---|---|---|---|---|---|---|
| Sarclisa | ISATUXIMAB | Sanofi-Aventis U.S. LLC | a0473462-6f9d-4eca-a5bf-8620aea68e8a | 2026-07-07 | Warnings, Adverse reactions | 2282032 |
DailyMed RxNorm Mappings#
| Set ID | RxNorm string | TTY | SPL version | Label | Effective |
|---|---|---|---|---|---|
| a0473462-6f9d-4eca-a5bf-8620aea68e8a | 25 ML isatuximab-irfc 20 MG/ML Injection [Sarclisa] | SBD | 17 | These highlights do not include all the information needed to use SARCLISA safely and effectively. See full prescribing information for SARCLISA. SARCLISA ® (isatuximab-irfc) injection, for intravenous use Initial U.S. Approval: 2020 | 20250616 |
| a0473462-6f9d-4eca-a5bf-8620aea68e8a | Sarclisa 500 MG per 25 ML Injection | SY | 17 | These highlights do not include all the information needed to use SARCLISA safely and effectively. See full prescribing information for SARCLISA. SARCLISA ® (isatuximab-irfc) injection, for intravenous use Initial U.S. Approval: 2020 | 20250616 |
| a0473462-6f9d-4eca-a5bf-8620aea68e8a | 25 ML Sarclisa 20 MG/ML Injection | SY | 17 | These highlights do not include all the information needed to use SARCLISA safely and effectively. See full prescribing information for SARCLISA. SARCLISA ® (isatuximab-irfc) injection, for intravenous use Initial U.S. Approval: 2020 | 20250616 |
| a0473462-6f9d-4eca-a5bf-8620aea68e8a | SARCLISA 500 MG in 25 ML Injection | PSN | 17 | These highlights do not include all the information needed to use SARCLISA safely and effectively. See full prescribing information for SARCLISA. SARCLISA ® (isatuximab-irfc) injection, for intravenous use Initial U.S. Approval: 2020 | 20250616 |