Home NDC 30237-8900 PROVENGE
Product NDC 30237-8900
11-digit product format 302378900
Labeler code 30237
Product ID 30237-8900_4044189e-1cb5-b6f5-e063-6394a90aeb7e
Type CELLULAR THERAPY
Nonproprietary name sipuleucel-T
Dosage form INJECTION
Route INTRAVENOUS
Labeler Dendreon Pharmaceuticals LLC
Application BLA125197
Marketing category BLA
Marketing start 2010-04-29
Substance SIPULEUCEL-T
Active strength 50000000 1/1
Pharmacologic classes Autologous Cellular Immunotherapy [EPC], Cell-mediated Immunity [PE], Cells, Cultured, Autologous [EXT], Leukocytes, Mononuclear [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base PROVENGE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SIPULEUCEL-T 50000000 1/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8Q622VDR18 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 997264 Internal RxNorm lookup 997267 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 30237-8900-5 PROVENGE 1 in 1 BAG INJECTION 1 19 30237-8900-6 PROVENGE 1 in 1 CARTON INJECTION 1 19
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 30237-8900 PROVENGE (SIPULEUCEL-T) INJECTION [DENDREON PHARMACEUTICALS LLC] 18 Current NDC, Legacy NDC, 2 package rows 20241012_8309b497-5d4e-4408-ac0c-2452c11c8a35.zip
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.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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 2026-07-01
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 997267 PROVENGE 50,000,000 CELLS in 250 ML Injection PSN 8309b497-5d4e-4408-ac0c-2452c11c8a35 19 997264 sipuleucel-T 50,000,000 CELLS in 250 ML Injection PSN 8309b497-5d4e-4408-ac0c-2452c11c8a35 19 997267 250 ML sipuleucel-T 200000 CELLS/ML Injection [Provenge] SBD 8309b497-5d4e-4408-ac0c-2452c11c8a35 19 997264 250 ML sipuleucel-T 200000 CELLS/ML Injection SCD 8309b497-5d4e-4408-ac0c-2452c11c8a35 19 997267 Provenge (minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF per 250 ML of Lactated Ringer's) Injection SY 8309b497-5d4e-4408-ac0c-2452c11c8a35 19 997267 Provenge 50,000,000 CELLS per 250 ML Injection SY 8309b497-5d4e-4408-ac0c-2452c11c8a35 19 997264 sipuleucel-T 50,000,000 CELLS per 250 ML Injection SY 8309b497-5d4e-4408-ac0c-2452c11c8a35 19
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 30237-8900-5 30237890005 1 in 1 BAG Historical 30237-8900-6 30237890006 1 BAG in 1 CARTON (30237-8900-6) / 1 INJECTION in 1 BAG (30237-8900-5) 1 bag 2010-04-29 0000-00-00 No No Current