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 table
BLA	Proprietary name	Proper name	License type	Status	Latest source
125197	Provenge	sipuleucel-T	351(a)	Rx	2026-06-01

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
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	Exact identifier rxcui: 997267

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set ID	RxNorm string	TTY	SPL version	Label	Effective
8309b497-5d4e-4408-ac0c-2452c11c8a35	PROVENGE 50,000,000 CELLS in 250 ML Injection	PSN	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
8309b497-5d4e-4408-ac0c-2452c11c8a35	Provenge (minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF per 250 ML of Lactated Ringer's) Injection	SY	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
8309b497-5d4e-4408-ac0c-2452c11c8a35	Provenge 50,000,000 CELLS per 250 ML Injection	SY	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
8309b497-5d4e-4408-ac0c-2452c11c8a35	250 ML sipuleucel-T 200000 CELLS/ML Injection [Provenge]	SBD	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