FDA.reportPublic FDA data

NDC 0409-4755-01 - Ondansetron

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
0409-4755
Requested NDC
0409-4755-01
Package NDCs from labels
0409-4755-18, 0409-4755-03, 0409-4755-01
Manufacturer
Cardinal Health 107, LLC
Effective date
2026-06-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ondansetron - Cardinal Health 107, LLCCardinal Health 107, LLC2026-06-26HUMAN PRESCRIPTION DRUG LABEL
Ondansetron - Hospira, Inc. | Pfizer Healthcare India Private LimitedHospira, Inc. | Pfizer Healthcare India Private Limited2026-05-22HUMAN PRESCRIPTION DRUG LABEL
ONDANSETRON - HF Acquisition Co LLC, DBA HealthFirstHF Acquisition Co LLC, DBA HealthFirst2025-01-08HUMAN PRESCRIPTION DRUG LABEL
Ondansetron - REMEDYREPACK INC.REMEDYREPACK INC.2024-03-29HUMAN PRESCRIPTION DRUG LABEL
Ondansetron - Medical Purchasing Solutions, LLCMedical Purchasing Solutions, LLC2023-05-15HUMAN PRESCRIPTION DRUG LABEL
Ondansetron - NuCare Pharmaceuticals,Inc.NuCare Pharmaceuticals,Inc.2021-02-17HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-4755-03Ondansetron25 in 1 TRAYINJECTION, SOLUTION2534
0409-4755-18Ondansetron2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION234

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-4755ONDANSETRON INJECTION, SOLUTION [HOSPIRA, INC.]32Current NDC, Legacy NDC, 2 package rows20250109_6a11f61b-2318-4382-2b91-4366e4bb53fa.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-4755-01ML - Milliliter0409-47552c7bacb7-8a01-4c6b-bb92-fe3e8a5e19a212012-07-24
0409-4755-02ML - Milliliter0409-47554e46e9f5-3b4c-4ffd-bbe8-ed076eb1a68512012-07-24
0409-4755-03ML - Milliliter0409-47553a992647-f868-4adb-b6ea-71f9865aa61712012-07-24
0409-4755-11ML - Milliliter0409-4755efb609dd-6add-4e03-bb7a-a5828c25388b12015-04-03
0409-4755-12ML - Milliliter0409-475504775b37-24f0-4a50-a19b-f16c63c8490d12015-04-03
0409-4755-18ML - Milliliter0409-47553832c8a7-0b4a-4065-be59-c8b2976afa9e12015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ONDANSETRON HYDROCHLORIDEACTIVE INGREDIENTNMH84OZK2BONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.]15
ONDANSETRONACTIVE MOIETY4AF302ESOSONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.]15
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.]15
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.]15
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.]15
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.]15
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.]15
WATERINACTIVE INGREDIENT059QF0KO0RONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.]15
ONDANSETRON HYDROCHLORIDEACTIVE INGREDIENTNMH84OZK2BONDANSETRON HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH]3
ONDANSETRONACTIVE MOIETY4AF302ESOSONDANSETRON HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLONDANSETRON HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH]3
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XONDANSETRON HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH]3
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRONDANSETRON HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH]3
WATERINACTIVE INGREDIENT059QF0KO0RONDANSETRON HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH]3

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 8 of 64 · 1,279 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RingersSODIUM CHLORIDE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEICU Medical, Inc.a926f913-18fa-4a3e-bfd6-210e1e4279602026-04-20Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
OndansetronONDANSETRONCivica, Inc.70437694-0341-4f3b-824c-06843403443f2026-04-19Warnings, Adverse reactionsExact identifier
rxcui: 1740467
unii: NMH84OZK2B
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
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
OndansetronONDANSETRONHikma Pharmaceuticals USA Inc.97713356-f42b-4a67-95f6-561afa68c0c22026-04-16Warnings, Adverse reactionsExact identifier
rxcui: 283504
rxcui: 1740467
unii: NMH84OZK2B
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
CLENPIQSODIUM PICOSULFATE, MAGNESIUM OXIDE, AND ANHYDROUS CITRIC ACIDFerring Pharmaceuticals Inc.e95fff66-4ec0-4001-a727-33e66a5ec7d52026-04-15Warnings, Adverse reactionsExact identifier
unii: XF417D3PSL
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
OndansetronONDANSETRONSportpharm LLC98c1413c-ff7f-4554-9e9f-289038b39ca62026-04-14Warnings, Adverse reactionsExact identifier
application number: ANDA077473
rxcui: 283504
unii: NMH84OZK2B
Anticoagulant Sodium CitrateTRISODIUM CITRATE DIHYDRATELABORATORIOS GRIFOLS SAdb8334be-5b8b-4811-811a-efbe32b6d1472026-04-14WarningsExact identifier
unii: B22547B95K
SODIUM CHLORIDE 1 GRAMSODIUM CHLORIDEGendose Pharmaceuticals, LLCce988ae5-61c6-4324-90e1-a94c8a54d0d02026-04-13WarningsExact identifier
unii: 451W47IQ8X
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEREMEDYREPACK INC.5cc67d95-6629-4451-9e34-2f7a60482be52026-04-10Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
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
OndansetronONDANSETRONHikma Pharmaceuticals USA Inc.c29ca6df-621d-44b6-98fc-b486665733662026-04-09Warnings, Adverse reactionsExact identifier
rxcui: 283504
rxcui: 1740467
unii: NMH84OZK2B

Reported adverse events (FAERS/openFDA)#

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