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 15 of 70 · 1,394 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Melancholy Drops Extrovert 2015MELANCHOLY DROPS EXTROVERTProfessional Complementary Health Formulas2c9187ce-a52e-445e-a36e-fe374f5ad2e22026-01-08WarningsExact identifier
unii: 451W47IQ8X
RET Lung 7003RET LUNGProfessional Complementary Health Formulas2ed03832-f226-4b3c-9ee6-5352f8d79fdb2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Melancholy Drops Introvert 2016MELANCHOLY DROPS INTROVERTProfessional Complementary Health Formulas60e305b4-bb1f-465e-963d-38e6b38df98d2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Spleen Stim Liquescence 3028SPLEEN STIM LIQUESCENCEProfessional Complementary Health Formulas463b62a5-4d4f-445f-ba24-859195730cab2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Melancholy Drops 2002MELANCHOLY DROPSProfessional Complementary Health Formulas96d7f202-c19b-4914-96bb-9906ad781ad02026-01-08WarningsExact identifier
unii: 451W47IQ8X
Natrum Muriaticum 8009NATRUM MURIATICUMProfessional Complementary Health Formulasb4a48b58-28c0-4368-83e8-40ce52ae5f2b2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Aletris Combination 9203ALETRIS COMBINATIONProfessional Complementary Health Formulas87ae7310-927b-48fe-b659-6f93dad623632026-01-08WarningsExact identifier
unii: 451W47IQ8X
Fertility Drops 2174FERTILITY DROPSProfessional Complementary Health Formulas78985992-bb47-4045-82f3-a6094e48d50a2026-01-08WarningsExact identifier
unii: 451W47IQ8X
RET Liver 7008RET LIVERProfessional Complementary Health Formulasd81bdbbd-5cfa-40e3-99f5-fd5368239fbe2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Herbal Diuretic Liquescence 3011HERBAL DIURETIC LIQUESCENCEProfessional Complementary Health Formulas5eee7f21-a3c4-46e0-a642-a4ca635734e32026-01-08WarningsExact identifier
unii: 451W47IQ8X
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEAdvagen Pharma Limiteda9e9d134-55d0-47ae-925f-de07e7ffa4b82026-01-07Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEAdvagen Pharma Ltd.f4497c26-da16-45b0-975d-81f2c21327042026-01-07Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Sodium chlorideSODIUM CHLORIDEBECTON DICKINSON AND COMPANYd39b7307-df67-4e68-acb0-2eda5dc612152026-01-07Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Potassium ChloridePOTASSIUM CHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23b10bd6-11bc-495e-bb05-ec332a9b3f212026-01-06Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium Chloride for Oral SolutionPOTASSIUM CHLORIDE FOR ORAL SOLUTIONBPI Labs LLC1ea4345e-f8bb-4d41-9003-c87b21169d7c2026-01-05Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Lung DrainageANTIMONIUM ARSENICICUM, BRYONIA (ALBA), CAMPHORA, CARBO VEGETABILIS, CHELIDONIUM MAJUS, CHININUM MURIATICUM, CUPRUM METALLICUM, GELSEMIUM SEMPERVIRENS, HAEMOPHILUS INFLUENZAE B, IPECACUANHA, KALI MURIATICUM, LOBELIA PURPURESCENS, LUNG (SUIS), MYCOPLASMA PNEUMONIAE, MYCOPLASMA PNEUMONIAE DNA, OXYGENIUM, PHOSPHORUS, PNEUMOCOCCINUM, SENEGA OFFICINALIS, STANNUM METALLICUM, VERATRUM VIRIDEDeseret Biologicals, Inc.64a99cd3-341a-44ec-b4eb-c06982e6d4142026-01-05WarningsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDENorthwind Health Company, LLCf2b671c9-9874-2668-e053-2a95a90a1b462026-01-01Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDENorthwind Health Company, LLCf3081031-8234-5732-e053-2995a90aebeb2026-01-01Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDENorthwind Health Company, LLCdae7c63d-eef0-58d0-e053-2a95a90a667e2026-01-01Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDENorthwind Health Company, LLCdb4dc4ab-e0d4-7dc7-e053-2995a90ac46e2026-01-01Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10

Reported adverse events (FAERS/openFDA)#

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