FDA.reportPublic FDA data

NDC 0409-3435-01 - Fluconazole

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
0409-3435
Requested NDC
0409-3435-01
Package NDCs from labels
0409-3435-01, 0409-3435-24
Manufacturer
Hospira, Inc | InfoRLife SA | Infomed Fluids Srl
Effective date
2024-12-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Fluconazole - Hospira, Inc | InfoRLife SA | Infomed Fluids SrlHospira, Inc | InfoRLife SA | Infomed Fluids Srl2024-12-05HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-3435-01Fluconazole1 in 1 POUCHINJECTION, SOLUTION12
0409-3435-01Fluconazole100 mL in 1 BAGINJECTION, SOLUTION1002
0409-3435-24Fluconazole24 in 1 CARTONINJECTION, SOLUTION242

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-3435FLUCONAZOLE INJECTION, SOLUTION [HOSPIRA, INC]2Current NDC, 3 package rows20250107_22ebc3fb-ee81-44bd-a6e3-5e759ee724a8.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-3435-01ML - Milliliter0409-343536a44253-5845-49c0-b4ed-582b96c4f80212025-02-10
0409-3435-24ML - Milliliter0409-343597f0e8ed-cbfa-48d5-936a-0baa40c031bf12025-02-10

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 7 of 56 · 1,111 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FluconazoleFLUCONAZOLEREMEDYREPACK INC.2cbf3c6c-318c-4dd9-ad44-a8eb9eccb0f52026-05-01Warnings, Adverse reactionsExact identifier
unii: 8VZV102JFY
FluconazoleFLUCONAZOLECardinal Health 107, LLCf1bfba3a-5b18-41c0-9084-b1f26bb93ef22026-04-27Warnings, Adverse reactionsExact identifier
unii: 8VZV102JFY
Sodium ChlorideSODIUM CHLORIDESportpharm LLCa2c111f6-74d5-4a5d-82ac-d0f237488cb82026-04-24Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
FluconazoleFLUCONAZOLESportpharm LLC8a4d6d9e-02ae-42e4-83ec-f5c4e135273b2026-04-24Warnings, Adverse reactionsExact identifier
unii: 8VZV102JFY
Sodium ChlorideSODIUM CHLORIDEMethod Pharmaceuticals, LLC4b08859e-65bd-8255-e063-6394a90af6142026-04-23WarningsExact identifier
unii: 451W47IQ8X
RingersSODIUM CHLORIDE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEICU Medical, Inc.a926f913-18fa-4a3e-bfd6-210e1e4279602026-04-20Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Cardioforce IIABROTANUM, BOLDO, CIMICIFUGA RACEMOSA, KALI PHOSPHORICUM, TARAXACUM OFFICINALE, CONVALLARIA MAJALIS, MAGNESIA SULPHURICA, OLEANDER, NATRUM MURIATICUM, BELLIS PERENNISBioActive Nutritional, Inc.733bbb26-7698-4a1b-9dc8-7e3490ffc92b2026-04-17WarningsExact identifier
unii: 451W47IQ8X
Thyroid HPBARYTA CARBONICA, CALCAREA CARBONICA, FUCUS VESICULOSUS, IODIUM, NATRUM MURIATICUM, PULSATILLA, SPONGIA TOSTA, THYROIDINUM (SUIS)BioActive Nutritional, Inc.3795820a-cf2a-4094-9a02-70e3757b75102026-04-17WarningsExact identifier
unii: 451W47IQ8X
FluconazoleFLUCONAZOLEPreferred Pharmaceuticals Inc.eeeb82e1-d668-418e-9716-f8bcf72f80c02026-04-17Warnings, Adverse reactionsExact identifier
unii: 8VZV102JFY
DIANEAL Low Calcium with DextroseSODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSEVantive US Healthcare LLCaa268d3f-7389-4f25-801f-5d4825495f082026-04-16Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
FluconazoleFLUCONAZOLEPreferred Pharmaceuticals Inc.5cbd78cd-2cd7-4882-9902-bdb7812fbc6b2026-04-16Warnings, Adverse reactionsExact identifier
unii: 8VZV102JFY
PEG 3350 and ElectrolytesPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDEWilshire Pharmaceuticals, Inc.b251752d-7750-482a-9364-0acf4ad47cc82026-04-16Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE AND SODIUM CHLORIDEFresenius Kabi USA, LLC99c6a1a9-cadf-435b-a332-ccc189afdfa92026-04-16Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
GoLYTELYPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDEAzurity Pharmaceuticals, Inc.7609ecf7-0ce0-4fbb-9c27-30987f6895752026-04-15Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
TRILYTEPOLYETHYLENE GLYOCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDEAurobindo Pharma Limited79f5e596-8d51-4227-afcc-f5e3411509572026-04-15Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Anxiety ReliefACONITUM NAPELLUS, ARGENTUM NITRICUM, ARSENICUM ALBUM, AURUM METALLICUM, GELSEMIUM SEMPERVIRENS, HYOSCYAMUS NIGER, IGNATIA AMARA, KALI CARBONICUM, MOSCHUS, NATRUM MURIATICUM, PIPER METHYSTICUMNaturalCare9f982e89-655c-49be-85d8-4099a02ed0212026-04-15WarningsExact identifier
unii: 451W47IQ8X
PEG 3350, sodium chloride, sodium bicarbonate and potassium chloridePOLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDEWilshire Pharmaceuticals, Inc.4e442a72-b13b-4869-8a1d-59356095b0912026-04-14Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
SODIUM CHLORIDE 1 GRAMSODIUM CHLORIDEGendose Pharmaceuticals, LLCce988ae5-61c6-4324-90e1-a94c8a54d0d02026-04-13WarningsExact identifier
unii: 451W47IQ8X
Quantum ResonanceALCOHOLUS, ALUMINA SILICATA, ANACARDIUM ORIENTALE, AQUA MARINA, BAPTISIA TINCTORIA, CANDIDA ALBICANS, COLLAGEN, DNA, LAVANDULA OFFICINALIS, MEDULLA OSSIS SUIS, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NUX MOSCHATA, PHOSPHORUS, QUARTZ, SILICEA, TELA ARANEA, VALERIANA OFFICINALIS, VISCUM ALBUMDeseret Biologicals, Inc.f94a10bd-1c40-42c7-b458-b580706145492026-04-10WarningsExact identifier
unii: 451W47IQ8X
Quantum ResonanceALCOHOLUS, ALUMINA SILICATA, ANACARDIUM ORIENTALE, AQUA MARINA, BAPTISIA TINCTORIA, CANDIDA ALBICANS, COLLAGEN, DNA, LAVANDULA OFFICINALIS, MEDULLA OSSIS SUIS, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NUX MOSCHATA, PHOSPHORUS, QUARTZ, SILICEA, TELA ARANEA, VALERIANA OFFICINALIS, VISCUM ALBUMDeseret Biologicals, Inc.1467111a-bef6-473d-b7f2-3309a9bb72ce2026-04-10WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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