FDA.reportPublic FDA data

NDC 30237-8900-5 - 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
30237-8900-5
Package NDCs from labels
30237-8900-5, 30237-8900-6
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 28 of 70 · 1,394 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cold Sore Treatment Extra StrengthECHINACEA ANGUSTIFOLIA WHOLE, SODIUM CHLORIDE, THUJA OCCIDENTALIS LEAFY TWIG, AND CALENDULA OFFICINALIS FLOWERING TOPForces of Nature0a5d32dc-c0e7-404e-85f2-6c3a338560ba2025-08-22WarningsExact identifier
unii: 451W47IQ8X
IncontinenceALOE, ARG. NIT., ARSENICUM ALB., BELLADONNA, BENZOICUM ACIDUM, BRYONIA, CANTHARIS, CAUSTICUM, EQUISETUM HYEMALE, FERRUM METALLICUM, GELSEMIUM, IGNATIA, KALI PHOS., LYCOPODIUM, NAT. MUR., NITRICUM AC., PLANTAGO, PULSATILLA, RHUS AROMATICA , SABAL, SECALE, SEPIA, STAPHYSAG.,STRAMONIUM, THYROIDINUM, VERBASCUM, ECHINACEA, HYDRASTISNewton Laboratories, Inc.994cbc8e-a221-1548-e053-2995a90a1f7f2025-08-20WarningsExact identifier
unii: 451W47IQ8X
Jacksons Cell Salts NAT MUR 6X 9NATRUM MURIATICUMZettl Health Inc.3cbe47fc-db38-e6e9-e063-6294a90a3f1c2025-08-19WarningsExact identifier
unii: 451W47IQ8X
Schuessler Tissue Salts Comb D Skin DisordersKALI MURIATICUM,KALI SULPHURICUM,CALCAREA SULPHURICA,SILICEAMartin & Pleasance Pty Ltd617303f8-4463-4a1e-a502-44abc181d91f2025-08-13WarningsExact identifier
unii: 660YQ98I10
Schuessler Tissue Salts Comb D Skin DisordersKALI MURIATICUM,KALI SULPHURICUM,CALCAREA SULPHURICA,SILICEAMartin & Pleasance Pty Ltd03153d92-dc68-4b84-a8c9-634b1ffd7da12025-08-13WarningsExact identifier
unii: 660YQ98I10
QUALITY CHOICE SALINESODIUM CHLORIDEQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)f51491d8-12ad-4b1b-a171-c621bfdcc3412025-08-12WarningsExact identifier
unii: 451W47IQ8X
Potassium ChloridePOTASSIUM CHLORIDEHenry Schein, Inc.bf8e8ac7-e6a8-4571-a0ea-7bcab89290f62025-08-12Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDEAvKARE3bdfced1-6e62-9e92-e063-6294a90a28aa2025-08-08Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEAphena Pharma Solutions - Tennessee, LLC3be29fcc-765e-8653-e063-6394a90a59d52025-08-08Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Sodium ChlorideSODIUM CHLORIDEHenry Schein, Inc.e0466bb3-6c26-4044-b051-69f48b67f6322025-08-07Adverse reactionsExact identifier
unii: 451W47IQ8X
Potassium ChloridePOTASSIUM CHLORIDESlate Run Pharmaceuticals, LLC94ae03cc-b620-0dbb-e053-2a95a90a922c2025-08-07Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDESlate Run Pharmaceuticals, LLC0cc57ece-f15a-4160-a5ea-8d6fa9f9e7542025-08-07Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDEPD-Rx Pharmaceuticals, Inc.47a87fb6-5e61-41c9-b759-10f7c74a67ce2025-08-05Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Schuessler Tissue Salts Nat Mur Fluid Balance 9NATRUM MURIATICUMMartin & Pleasance Pty Ltd08da6353-9625-4e8f-8575-a2b49f5d2ac62025-08-04WarningsExact identifier
unii: 451W47IQ8X
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEAmerican Health Packaging7956883f-0d31-4081-bbea-d9ea320a193b2025-08-04Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Gout Relief 3310-SCELERY SEED, MEDICAGO SATIVA WHOLE,CHICORY ROOTBispit Canada Ltd.3afaa7d9-3de3-52d9-e063-6294a90a54ec2025-08-02WarningsExact identifier
unii: 451W47IQ8X
Potassium Chloride for Oral SolutionPOTASSIUM CHLORIDE FOR ORAL SOLUTIONMarlex Pharmaceuticals Inc3e78028d-21a0-ba0f-e063-6294a90aac492025-08-01Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium Chloride for Oral SolutionPOTASSIUM CHLORIDE FOR ORAL SOLUTIONMarlex Pharmaceuticals, Inc.3e8a6f61-44eb-4b5a-e063-6294a90a4b1b2025-08-01Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
POTASSIUM CHLORIDE EXTENDED RELEASEPOTASSIUM CHLORIDEAphena Pharma Solutions - Tennessee, LLC3b403d60-4246-d765-e063-6394a90a12e82025-07-31Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEA-S Medication Solutions162a8ab5-76cf-48fa-8487-7780ed65647e2025-07-31Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10

Reported adverse events (FAERS/openFDA)#

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