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 18 of 64 · 1,279 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Equate Yeast ReliefCANDIDA ALBICANS, WOOD CREOSOTE, SODIUM CHLORIDE, AND SULFURWAL-MART STORES INCd96aa608-ed8a-36cd-e053-2a95a90ac2862025-12-17WarningsExact identifier
unii: 451W47IQ8X
OP-PEMOTIONAL HEALTH BOOSTERVitality Works, Inc.a8b87a49-fc73-4494-8dc9-059bc5f82d422025-12-17WarningsExact identifier
unii: 451W47IQ8X
Category VIMMUNE SYSTEM BOOSTERVitality Works, Inc,0d3dd923-336c-4ccd-a344-ec49b2e80d102025-12-17WarningsExact identifier
unii: XF417D3PSL
Vital-FLBODY FLUID BALANCEVitaltiy Works, Inc.13207197-7ef7-49a3-8970-5f98299a75d22025-12-17WarningsExact identifier
unii: 451W47IQ8X
Woman PowerAGNUS, ARALIA QUIN, ARNICA, DAMIANA, LACTUCA, NAT MUR, ONOSMODIUM VIRGINIANUM, OOPHORINUM, PHOSPHORICUM AC, PITUITARUM POSTERIUM, SALIX NIG, SEPIA, THUJA OCCEight and Company L.L.C614d47de-742b-4944-89c8-59f2f58dc8b92025-12-17WarningsExact identifier
unii: 451W47IQ8X
PSORIASIS HPARSENICUM ALBUM, ARSENICUM IODATUM, BORAX, CALCAREA CARBONICA, GRAPHITES, MEZEREUM, PROTEUS, NATRUM MURIATICUM, PHYTOLACCA DECANDRA, SEPIA, SILICEA, SULPHUR, THYROIDINUMNatural Creations, Inc.d2522637-fd16-4246-90d8-f90fb224550e2025-12-16WarningsExact identifier
unii: 451W47IQ8X
MoodARALIA QUIN, CIMICIFUGA, SPIGELIA ANTH, ARG NIT, ARSENICUM ALB, AURUM MET, IGNATIA AMARA, LACHESIS, LYCOPODIUM, NAT MUR, PHOSPHORICUM AC, PLATINUM MET, PULSATILLA, SEPIA, THUJA OCCNatural Creations, Inc7f143f30-2b72-4e6c-985c-8d3a485dbdb42025-12-16WarningsExact identifier
unii: 451W47IQ8X
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEQPharma, Inc.fbe71308-2927-2467-e053-6394a90aa4192025-12-16Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
IODIUM HPBARIUM CARBONATE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, FUCUS VESICULOSUS, IODINE, SODIUM CHLORIDE, PULSATILLA VULGARIS, SPONGIA OFFICINALIS SKELETON, ROASTED, THYROIDNatural Creations, Inc.9353d604-e168-4df1-9726-e965c9fc2c782025-12-16WarningsExact identifier
unii: 451W47IQ8X
SINUS HPAMBROSIA ARTEMISIIFOLIA, ARSENIC TRIOXIDE, CALCIUM SULFIDE, POTASSIUM DICHROMATE, POTASSIUM SULFATE, LYCOPODIUM CLAVATUM SPORE, MERCURIUS SOLUBILIS, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS, SEPIA OFFICINALIS JUICE, SILICON DIOXIDE, THUJA OCCIDENTALIS LEAFY TWIGNatural Creations, Inc.f017da22-74c2-40f4-adcc-5e84b6ea52912025-12-16WarningsExact identifier
unii: 451W47IQ8X
Hydrate 1BERBERISAQUI,BETAVULGARIS,BOLDO,CARDUUSMARIANUS,CHELIDONIUMMAJUS,ELEUTHEROCOCCUS SENTICOSUS,HORDEUMVULGARE,IRISVERSICOLOR,ROSMARINUSOFFICINALIS,TARAXACUMOFFICINALE,XANTHOXYLUMFRAXINEUM,ULMUSFULVA,GLYCYRRHIZAGLABRA,GETTYSBURGAQUA,WILDBADAQUA,CARLSBADAQUA,ATP,NATRUMMURIATICUM,OXYGEN,SILICEA,WIESBADENAQUA,HYDROGENNatural Creations, Inc189bc53c-5d75-48df-a74e-cfff2d08d3a92025-12-16WarningsExact identifier
unii: 451W47IQ8X
Hydrate 2BERBERISAQUIFOLIUM,BETAVULGARIS,BOLDO,CHELIDONIUMMAJUS,HORDEUMVULGARE,IRISVERSICOLOR,ROSMARINUSOFFICINALIS,CARDUUSMARIANUS,TARAXACUMOFFICINALE,AVENASATIVA,ELEUTHEROCOCCUSSENTICOSUS,XANTHOXYLUMFRAXINEUM,EQUISETUMHYEMALE,HYPERICUMPERFORATUM,ULMUSFULVA,GETTYSBURGAQUA,GLYCYRRHIZAGLABRA,WILDBADAQUA,CARLSBADAQUA,ATP,HYDROGEN,NATRUMMURIATICUM,OXYGEN,SILICEA,WIESBADENAQUANatural Creations, Inc1122605f-715e-4f12-9d9d-a20442f9cd452025-12-16WarningsExact identifier
unii: 451W47IQ8X
Migraine Headache TherapyATROPA BELLADONNA - BRYONIA ALBA ROOT - BLACK COHOSH - ARABICA COFFEE BEAN - NITROGLYCERIN - IRIS VERSICOLOR ROOT - SODIUM CHLORIDE -TRP Company317d3f42-783e-02b7-e054-00144ff88e882025-12-15WarningsExact identifier
unii: 451W47IQ8X
Mucus and Sinus Mucus and Sinus Symptom ReliefBRYONIA ALBA, HYDRASTIS CANADENSIS, KALI BICHROMICUM, NATRUM MURIATICUM, PULSATILLA PRATENSIS, SILICEA, STANNUM METALLICUM, THUJA OCCIDENTALIS, ZINCUM GLUCONICUMTRP Company2a42c4a3-9486-9b29-e063-6294a90a7c702025-12-15WarningsExact identifier
unii: 451W47IQ8X
Natural Relief Cold and Flu Plus ZincALLIUM CEPA, ARSENICUM ALBUM, BRYONIA ALBA, EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, NATRUM MURIATICUM, NUX VOMICA, SILICEA, SULPHUR, ZINCUM GLUCONICUMTRP Company2a352cf2-48fb-4862-e063-6294a90a2eeb2025-12-15WarningsExact identifier
unii: 451W47IQ8X
Natural Relief Cough and Congestion Cough and Congestion Symptom ReliefANTIMONIUM TARTARICUM, COCCUS CACTI, CUPRUM METALLICUM, DROSERA ROTUNDIFOLIA, ECHINACEA ANGUSTIFOLIA, KALI CARBONICUM, MEPHITIS MEPHITICA, NATRUM MURIATICUM, RUMEX CRISPUS, ZINCUM GLUCONICUMTRP Company2a430f41-bd33-32af-e063-6394a90ae8012025-12-15WarningsExact identifier
unii: 451W47IQ8X
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEQPharma, Inc.2fa30bdb-f60e-40a7-98b4-c346bc85d5392025-12-15Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEQPharma, Inc.dafe875e-391f-47a2-97b7-89840a760e442025-12-15Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
Sinu-RiteGLYCYRRHIZA, KALI BIC, NAT MUR, PULSATILLA, SAMBUCUSSILVER STAR BRANDSb79e177c-6bd7-2f9a-e053-2a95a90abedb2025-12-12WarningsExact identifier
unii: 451W47IQ8X
HEADACHE HPSILVER NITRATE, ATROPA BELLADONNA, BRYONIA ALBA ROOT, GELSEMIUM SEMPERVIRENS ROOT, NITROGLYCERIN, LACHESIS MUTA VENOM, LYCOPODIUM CLAVATUM SPORE, MELILOTUS OFFICINALIS TOP, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, SILICON DIOXIDE, SPIGELIA ANTHELMIANatural Creations, Inc.c38b83f0-3918-4ef6-8dfd-48fe438e584a2025-12-12WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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