PROVENGE 50,000,000 CELLS in 250 ML Injection
- RxCUI
- 997267
- RxNorm name
- PROVENGE 50,000,000 CELLS in 250 ML Injection
- Display name
- PROVENGE 50,000,000 CELLS in 250 ML Injection
- Full name
- PROVENGE 50,000,000 CELLS in 250 ML Injection
- Term type
- PSN
- Status
- DailyMed mapping
- Updated
- 2026-06-04 23:39:06
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 125197 | Provenge | sipuleucel-T | 351(a) | Rx | 2026-07-01 |
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 |
|---|---|---|---|---|---|---|
| PROVENGE | SIPULEUCEL-T | Dendreon Pharmaceuticals LLC | 8309b497-5d4e-4408-ac0c-2452c11c8a35 | 2025-10-03 | Warnings, Adverse reactions | 997267 |
DailyMed RxNorm Mappings#
| Set ID | RxNorm mappings | Terms | SPL version | Label | Effective |
|---|---|---|---|---|---|
| 8309b497-5d4e-4408-ac0c-2452c11c8a35 | PROVENGE 50,000,000 CELLS in 250 ML Injection [PSN] · 250 ML sipuleucel-T 200000 CELLS/ML Injection [Provenge] [SBD] · Provenge (minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF per 250 ML of Lactated Ringer's) Injection [SY] · Provenge 50,000,000 CELLS per 250 ML Injection [SY] | 4 | 19 | These highlights do not include all the information needed to use PROVENGE ® (sipuleucel-T) safely and effectively. See full prescribing information for PROVENGE. PROVENGE ® (sipuleucel-T) Suspension for Intravenous Infusion Initial U.S. Approval: 2010 | 20251003 |