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 54 of 70 · 1,394 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bone LiquescenceTARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, CALCAREA MURIATICA, EQUISETUM ARVENSE, JUGLANS NIGRA, SESAME OIL, CALCAREA SULPHURICA, HEPAR SUIS, KIDNEY (SUIS), MEDULLA OSSIS SUIS, MENADIONE, THYROIDINUM (BOVINE), VITAMIN A, VITAMIN D3, CALCAREA PHOSPHORICA, CALCAREA CARBONICA, CALCAREA FLUORICA, MANGANUM METALLICUM, NICCOLUM METALLICUM, MAGNESIUM METALLICUMNutritional Specialties, Inc.5d323e16-e9a5-4933-9593-285c7b3c54ce2023-11-17WarningsExact identifier
unii: M4I0D6VV5M
Potassium ChloridePOTASSIUM CHLORIDESun Pharmaceutical Industries, Inc.0a1f2f64-3b0b-5e5c-e063-6294a90a71852023-11-14Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Natrum muriaticumSODIUM CHLORIDEBoiron8646d7ea-cf5e-607d-e053-2a91aa0aeca12023-11-14Exact identifier
unii: 451W47IQ8X
Natrum muriaticumSODIUM CHLORIDEBoiron86466121-7217-d053-e053-2a91aa0a8f8a2023-11-14Exact identifier
unii: 451W47IQ8X
Natrum muriaticumSODIUM CHLORIDEBoiron864669c9-5bdc-232f-e053-2a91aa0a1fc62023-11-14Exact identifier
unii: 451W47IQ8X
Natrum muriaticumSODIUM CHLORIDEBoiron86462e06-d221-36b7-e053-2991aa0a1d822023-11-14Exact identifier
unii: 451W47IQ8X
Kali muriaticumPOTASSIUM CHLORIDEBoiron86093c75-6de0-bb16-e053-2991aa0ab6ef2023-11-13Exact identifier
unii: 660YQ98I10
Kali muriaticumPOTASSIUM CHLORIDEBoiron86090ebb-0fb2-2c9c-e053-2a91aa0a05612023-11-13Exact identifier
unii: 660YQ98I10
Kali muriaticumPOTASSIUM CHLORIDEBoiron8608a8de-8133-1d4b-e053-2991aa0a907a2023-11-13Exact identifier
unii: 660YQ98I10
Kali muriaticumPOTASSIUM CHLORIDEBoiron860887e7-7eaf-78c2-e053-2991aa0a9a752023-11-13Exact identifier
unii: 660YQ98I10
Kali muriaticumPOTASSIUM CHLORIDEBoiron86086aab-c411-7cf2-e053-2991aa0a81bd2023-11-13Exact identifier
unii: 660YQ98I10
Kali muriaticumPOTASSIUM CHLORIDEBoiron8608a379-c3b7-3053-e053-2a91aa0a2e652023-11-13Exact identifier
unii: 660YQ98I10
Kali muriaticumPOTASSIUM CHLORIDEBoiron8608f3dd-31bf-0182-e053-2991aa0a10302023-11-13Exact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDELupin Pharmaceuticals, Inc.1f33bcfe-c28a-4800-9241-685d974a5d912023-11-08Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Mineffect nasal mistCALCAREA SILICATA, SILICEA, SULPHUR, NATRUM MURIATICUM, FERRUM METALLICUM, FERRUM PHOSPHORICUM, PHOSPHORUS, FERRUM MURIATICUM, TITANIUM METALLICUM,Kadesh Incoporation Co,Ltd3a29bf95-a8a3-4517-aedf-0cd4a91b349c2023-10-31WarningsExact identifier
unii: 451W47IQ8X
InsomniaAQUILEGIA VULGARIS, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HUMULUS LUPULUS, HYPERICUM PERFORATUM, KALI PHOSPHORICUM, MELATONIN, MELISSA OFFICINALIS, NATRUM MURIATICUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALISLiddell Laboratories, Inc.18c15f17-1a16-4595-9d23-20353363cd722023-10-31WarningsExact identifier
unii: 451W47IQ8X
SalineNASALGERI-CARE PHARMACEUTICAL CORPd293cc13-4043-0d58-e053-2995a90a3fbc2023-10-24WarningsExact identifier
unii: 451W47IQ8X
Natrum muriaticumSODIUM CHLORIDEBoiron8644ffef-f0ec-5c06-e053-2a91aa0ae83d2023-10-23Exact identifier
unii: 451W47IQ8X
Aqua marinaSODIUM CHLORIDEBoiron6a212a52-32be-21b8-e053-2991aa0aea2f2023-10-22Exact identifier
unii: 451W47IQ8X
Kali muriaticumPOTASSIUM CHLORIDEBoironcaaad470-7be1-11e6-b409-424c583030312023-10-16Exact identifier
unii: 660YQ98I10

Reported adverse events (FAERS/openFDA)#

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