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 43 of 70 · 1,394 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DANGTTEOLMINERAL WATERAQBC CO., LTD27db14a9-3812-433f-e063-6394a90a11e72024-11-26WarningsExact identifier
unii: 059QF0KO0R
ReHydrationADENOSINUM CYCLOPHOSPHORICUM, COFFEA CRUDA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS, KALI PHOS, NAT MUR, SARSAPARILLA, SILICEA, TARAXACUM, THYROIDINUMEnergetix Corporation37063a49-6b45-4167-875d-49c9dac3f79b2024-11-20WarningsExact identifier
unii: 451W47IQ8X
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEPD-Rx Pharmaceuticals, Inc.ccaaa3a2-a273-41c7-9e54-429539ea01402024-11-19Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDEPAI Holdings, LLC dba PAI Pharmae848477f-b10d-4249-b322-b70cd6a062de2024-11-19Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
potassium chloridePOTASSIUM CHLORIDEA-S Medication Solutions3a720078-f455-44ab-a883-e3c13d83a74c2024-11-18Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
potassium chloridePOTASSIUM CHLORIDEA-S Medication Solutionscf014023-5300-455f-9f7f-fefb2e3639862024-11-18Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Company99a15716-bbb9-4e33-a48d-20c58b81f3922024-11-13Exact identifier
unii: 451W47IQ8X
potassium chloridePOTASSIUM CHLORIDEBryant Ranch Prepackf22606a5-ac9f-44fc-bb7b-08f3cf56c9992024-11-12Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Itch FormulaANTIPYRINUM, APIS MELLIFICA, CALENDULA OFFICINALIS, CANTHARIS, COPAIVA OFFICINALIS, CROTON TIGLIUM, GRAPHITES, HISTAMINUM HYDROCHLORICUM, LEDUM PALUSTRE, MEZEREUM, NATRUM MURIATICUM, PETROLEUM, RHUS VENENATA, STAPHYSAGRIA, SULPHUR, URTICA URENSDeseret Biologicals, Inc.4dfb177b-bff3-4b6d-8fd9-cadd1df7812c2024-11-12WarningsExact identifier
unii: 451W47IQ8X
Plasma-Lyte 148 (pH 7.4)SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDEBaxter Healthcare Corporationfe935c8d-f42d-42e4-8665-0dc66829f2312024-11-08Exact identifier
unii: 451W47IQ8X
unii: 660YQ98I10
Crane Safety Eye WashWATER SOLUTIONCrane Safety LLC96d8dda9-6cd6-3f68-e053-2995a90a0da22024-11-08WarningsExact identifier
unii: 059QF0KO0R
Calcium ChlorideCALCIUM CHLORIDECivica, Inc.7fa5d8e8-0610-4892-907e-5ef630a56e762024-11-08Warnings, Adverse reactionsExact identifier
unii: M4I0D6VV5M
RUGBY EYE WASHWATER, PURIFIEDA-S Medication Solutions0773e558-2f46-494c-888a-3bc517202b652024-11-08WarningsExact identifier
unii: 059QF0KO0R
FinazolFERROUS FUMARATE, FOLATEPureTek Corporation24290823-022a-433b-e063-6394a90a8fd02024-11-07Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE AND SODIUM CHLORIDEBECTON DICKINSON AND COMPANYd3f90d2f-4536-4d32-800b-7a798f8a35db2024-11-07Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEHospira, Inc.8eb172da-dcd4-4660-4a8f-ad44a14b4af72024-11-06Adverse reactionsExact identifier
unii: 451W47IQ8X
Licefreee EverydaySODIUM CHLORIDETec Laboratories,Inc.407b5fd6-2331-2ba7-e054-00144ff88e882024-11-05WarningsExact identifier
unii: 451W47IQ8X
LicefreeeHEAD LICE TREATMENTTec Laboratories, Inc.08c9d3dd-7177-0148-e054-00144ff8d46c2024-11-05WarningsExact identifier
unii: 451W47IQ8X
Bladder ReliefCAUSTICUM, NATRUM MURIATICUM, NUX VOMICA, PULSATILLA (VULGARIS), SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALISMagni Company5d0db70c-6360-493b-bcf2-8dbc953141402024-11-05WarningsExact identifier
unii: 451W47IQ8X
VaccinesARNICA MONTANA, HYPERICUM PERFORATUM, LEDUM PALUSTRE, MORBILLINUM, NATRUM MURIATICUM, SILICEA, SULPHUR IODATUM, THUJA OCCIDENTALIS, URTICA URENSLiddell Laboratories, Inc.6e6e67d4-089e-4775-b4a4-5511953f6e3f2024-11-04WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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