FDA.reportPublic FDA data

NDC 30237-8900-06 - PROVENGE

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
30237-8900
Requested NDC
30237-8900-06
Package NDCs from labels
30237-8900-5, 30237-8900-6, 30237-8900-06
Manufacturer
Dendreon Pharmaceuticals LLC | Ann Davis
Effective date
2025-10-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PROVENGE - Dendreon Pharmaceuticals LLC | Ann DavisDendreon Pharmaceuticals LLC | Ann Davis2025-10-03CELLULAR THERAPY

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
30237-8900-62023-10-17C16284748780-1f386c649-dd08-0266-e053-dadaa90a7c1aThese 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
30237-8900-62023-01-30C16284748780-1f386c649-dd08-0266-e053-dadaa90a7c1aThese 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
30237-8900-5PROVENGE1 in 1 BAGINJECTION119
30237-8900-6PROVENGE1 in 1 CARTONINJECTION119

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30237-8900PROVENGE (SIPULEUCEL-T) INJECTION [DENDREON PHARMACEUTICALS LLC]18Current NDC, Legacy NDC, 2 package rows20241012_8309b497-5d4e-4408-ac0c-2452c11c8a35.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
30237-8900-6ML - Milliliter30237-8900dcc0a576-1c5a-4f3c-a7d1-792d34098abf12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Sipuleucel-TACTIVE INGREDIENT8Q622VDR18PROVENGE (SIPULEUCEL-T) INJECTION [DENDREON CORPORATION]9
Sipuleucel-TACTIVE MOIETY8Q622VDR18PROVENGE (SIPULEUCEL-T) INJECTION [DENDREON CORPORATION]9
Calcium ChlorideINACTIVE INGREDIENTM4I0D6VV5MPROVENGE (SIPULEUCEL-T) INJECTION [DENDREON CORPORATION]9
Potassium ChlorideINACTIVE INGREDIENT660YQ98I10PROVENGE (SIPULEUCEL-T) INJECTION [DENDREON CORPORATION]9
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XPROVENGE (SIPULEUCEL-T) INJECTION [DENDREON CORPORATION]9
Sodium LactateINACTIVE INGREDIENTTU7HW0W0QTPROVENGE (SIPULEUCEL-T) INJECTION [DENDREON CORPORATION]9
WaterINACTIVE INGREDIENT059QF0KO0RPROVENGE (SIPULEUCEL-T) INJECTION [DENDREON CORPORATION]9

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 25 of 70 · 1,394 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium Chloride Normal SaltSODIUM CHLORIDEMethod Pharmaceuticalsce84727a-3677-4bf0-e053-2995a90a3ec82025-10-21WarningsExact identifier
unii: 451W47IQ8X
Potassium chloridePOTASSIUM CHLORIDEMacleods Pharmaceuticals Limitede0562a05-4359-4256-87e3-fcde65a008cd2025-10-18Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
WalgreensSODIUM CHLORIDEWalgreen Company21dfc2cf-65ae-c3fb-e063-6294a90a0a942025-10-17Exact identifier
unii: 451W47IQ8X
Mold Relief FormulaKALI MURIATICUM, GELSEMIUM, KALI BICHROMICUM, SABADILLA, HISTAMINUM, MOLD MIX.Integrative Healing Institute, LLC067ee707-7219-4370-9cdd-08888f45b5e52025-10-17WarningsExact identifier
unii: 660YQ98I10
Seasonal Allergy FormulaHYDRASTIS CANADENSIS, KALI MURIATICUM, GELSEMIUM SEMPERVIRENS, KALI BICHROMICUM, SABADILLA, HISTAMINUM, HOUSE DUST, GRASS MIX, TREES MIX, WEEDS MIXIntegrative Healing Institute, LLC1d4deee9-5452-421b-a107-ab150d1f62142025-10-17WarningsExact identifier
unii: 660YQ98I10
KLOR-CON MPOTASSIUM CHLORIDECardinal Health 107, LLCee3a1815-7325-4838-9764-fe1db68877b62025-10-17Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Homeopathic Tea Tree Oil LiceEUCALYPTUS GLOBULUS, NATRUM MURIATICUMDOLGENCORP, LLC0a0c2db2-7eeb-909c-e063-6394a90a7a902025-10-15WarningsExact identifier
unii: 451W47IQ8X
Saline AmpoulesSODIUM CHLORIDE 0.9%Trifecta Pharmaceuticals USA, LLC.ee18ef7c-bb5d-30ec-e053-2a95a90a964e2025-10-13WarningsExact identifier
unii: 451W47IQ8X
Potassium ChloridePOTASSIUM CHLORIDEStrides Pharma Science Limitedf4e36462-3522-4130-8785-6c18871d29842025-10-10Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
EQUATE SALINE PACKETSNASAL CLEANING SALTWALMART INC9e905ecb-d4d5-514a-e053-2a95a90adfbb2025-10-08WarningsExact identifier
unii: 451W47IQ8X
EQUATE NETI POT SINUS WASHNASAL WASHWALMART INC9e90c1c1-4dcd-106e-e053-2995a90afd152025-10-08WarningsExact identifier
unii: 451W47IQ8X
GURUNANDA NASAL SALINENASAL WASHGURUNANDA LLC2b4d78ae-b587-6dfe-e063-6394a90a88762025-10-08WarningsExact identifier
unii: 451W47IQ8X
Sodium chlorideSODIUM CHLORIDEBecton Dickinson and Companyca3355f2-2cf0-4f58-bed5-0c4c0a7d35112025-10-08Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Potassium ChloridePOTASSIUM CHLORIDENorthstar Rx LLCfbed8c29-b3f1-4e53-b290-6f717290cecf2025-10-07Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Homeopathic Calm DropsARSENIC TRIOXIDE 30C, MATRICARIA CHAMOMILLA12X, ARABICA COFFEE BEAN 30X, POTASSIUM CARBONATE30C, STRYCHNOS IGNATII SEED30X, LACHESIS MUTA VENOM12X, PHOSPHORIC ACID 3X, ANEMONE PULSATILLA 12C, VALERIAN 30C, ACONITUM NAPELLUS 6X, CHLORIDE ION 12X, STRYCHNOS NUX-VOMICA SEED 30CHISTORICAL REMEDIES LLP.69c35bc2-b9a0-4bb4-a56d-0e2d1c3f79582025-10-07WarningsExact identifier
unii: 451W47IQ8X
Homeopathic Moon dropsARSENIC CATION 30X, MATRICARIA CHAMOMILLA 6X, ARABICA COFFEE BEAN 12X, GELSEMIUM SEMPERVIRENS ROOT 12X, STRYCHNOS IGNATII SEED 30X, LYCOPODIUM CLAVATUM SPORE 30X, SODIUM CHLORIDE 30X, STRYCHNOS NUX VOMICA SEED 30X, VALERIAN 12C,Historical Remedies LLP0e7972a5-a930-4a52-8896-02ce810fa90b2025-10-07WarningsExact identifier
unii: 451W47IQ8X
Tri-Relief AntifungalSODIUM CHLORIDE, SILICON DIOXIDE, AND THUJA OCCIDENTALIS LEAFY TWIGForces of Nature6fe97b54-8aa3-4d86-9055-0629589a416b2025-10-06WarningsExact identifier
unii: 451W47IQ8X
Bone LiquescenceTARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, CALCAREA MURIATICA, EQUISETUM ARVENSE, JUGLANS NIGRA, SESAME OIL, CALCAREA SULPHURICA, HEPAR (BOVINE), KIDNEY (BOVINE), MEDULLA OSSIS SUIS, MENADIONE, THYROIDINUM (BOVINE), VITAMIN A, VITAMIN D3, CALCAREA PHOSPHORICA, CALCAREA CARBONICA, CALCAREA FLUORICA, MANGANUM METALLICUM, NICCOLUM METALLICUM, MAGNESIUM METALLICUMNutritional Specialties, Inc.28c244ca-7a99-4750-9942-32fdf4d3dac92025-10-06WarningsExact identifier
unii: M4I0D6VV5M
PROVENGESIPULEUCEL-TDendreon Pharmaceuticals LLC8309b497-5d4e-4408-ac0c-2452c11c8a352025-10-03Warnings, Adverse reactionsExact identifier
application number: BLA125197
ndc (package): 30237-8900-6
ndc (package): 30237-8900-5
ndc (product): 30237-8900
ndc11 (package): 30237890006
rxcui: 997267
rxcui: 997264
spl id: 4044189e-1cb5-b6f5-e063-6394a90aeb7e
spl set id: 8309b497-5d4e-4408-ac0c-2452c11c8a35
unii: 8Q622VDR18
VirexADENOVIREN NOSODE, ASCLEPIAS TUBEROSA, CALCAREA ARSENICICA, CAMPHORA, COXSACKIE A2 NOSODE, COXSACKIE A3 NOSODE, COXSACKIE A4 NOSODE, COXSACKIE A5 NOSODE, COXSACKIE A7 NOSODE, COXSACKIE B1 NOSODE, COXSACKIE B3 NOSODE, COXSACKIE B4 NOSODE, COXSACKIE B5 NOSODE, CYTOMEGALOVIRUS NOSODE, ECHINACEA PURPUREA, EPSTEIN-BARR VIRUS NOSODE, EUPHRASIA OFFICINALIS, INFLUENZINUM, LAC VACCINUM, MORBILLINUM, NATRUM MURIATICUM, PHYTOLACCA DECANDRA, THUJA OCCIDENTALIS, TRIFOLIUM PRATENSE, VARIOLINUMNutritional Specialties, Inc.4baa5c95-79a6-4ae8-a8c4-1edbf308f92c2025-10-03WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.