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 33 of 64 · 1,279 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDENuCare Pharmaceuticals,Inc.f8ada0e4-5c1b-17ab-e053-6294a90a12b82025-02-06Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
4 Kids Cold and Cough NighttimeONION, CALCIUM SULFIDE, SODIUM CHLORIDE, ANEMONE PULSATILLA, ARABICA COFFEE BEAN, MATRICARIA CHAMOMILLA, SULFUR, PHOSPHORUS AND GOLDENSEALHyland's Consumer Health Inc.71e93027-33c9-6147-e053-2a95a90aaa092025-02-06WarningsExact identifier
unii: 451W47IQ8X
Jacksons Cell Salts 12 IN 1CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEAZettl Health Inc.25ba49d0-0369-3666-e063-6294a90a71c42025-02-04Exact identifier
unii: 451W47IQ8X
Well at WalgreensSODIUM BICARBONATE, SODIUM CHLORIDEWalgreen Companycb5d3d9d-2481-4303-b6af-0002de8c90652025-01-31WarningsExact identifier
unii: 451W47IQ8X
Sinus Wash PacketSODIUM BICARBONATE, SODIUM CHLORIDERITE AID CORPORATIONd5b44ae7-81e8-1413-e053-2995a90a59332025-01-31WarningsExact identifier
unii: 451W47IQ8X
Sinus Wash Saline Refills MeijerSODIUM BICARBONATE, SODIUM CHLORIDEMeijer, Inc.dd7465fe-503a-4e34-e053-2995a90a27782025-01-31WarningsExact identifier
unii: 451W47IQ8X
SinuCleanseSODIUM BICARBONATE, SODIUM CHLORIDEASCENT CONSUMER PRODUCTS, INC.ff4df6c5-c85f-406a-89d7-8c2853fd5e102025-01-31WarningsExact identifier
unii: 451W47IQ8X
CVSSODIUM BICARBONATE, SODIUM CHLORIDECVS Pharmacybccefef8-f92d-42fc-90fc-86644d1df6552025-01-31WarningsExact identifier
unii: 451W47IQ8X
Well at WalgreensSODIUM BICARBONATE, SODIUM CHLORIDEWalgreen Companybcd336b4-9189-44d5-ae6d-81e535eff6b52025-01-31WarningsExact identifier
unii: 451W47IQ8X
SinuCleanseSODIUM BICARBONATE, SODIUM CHLORIDEASCENT CONSUMER PRODUCTS, INC.c33bf872-54aa-45e0-9e40-a6565a13f1982025-01-31WarningsExact identifier
unii: 451W47IQ8X
Sodium Chloride Normal SaltSODIUM CHLORIDECitragen Pharmaceuticals Incaae783b2-18fe-69ca-e053-2a95a90a08002025-01-30WarningsExact identifier
unii: 451W47IQ8X
Sodium Chloride Normal SaltSODIUM CHLORIDECitragen Pharmaceuticals Inc82c29f1d-a018-7483-e053-2a91aa0a8f7e2025-01-30WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BM63CEANOTHUS, KALI MUR, KALI ARS, OOPHRINUM, SELENIUM, THALLIUM, WEISBADENBestmade Natural Products2cea4552-3700-3da3-e063-6294a90a14b52025-01-30WarningsExact identifier
unii: 059QF0KO0R
Bestmade Natural Products BM68PHOSPHORUS, ARG NIT, GELSEMIUM, NAT MUR, KALI BROM, BARYTA CARBBestmade Natural Products2cec9c90-2e61-f005-e063-6294a90a87532025-01-30WarningsExact identifier
unii: 451W47IQ8X
RecovatoneGLYCYRRHIZA GLABRA, KALI MURIATICUM, KALI PHOSPHORICUM, IODIUM, ZINCUM GLUCONICUM, PHOSPHORUS, ASCORBICUM ACIDUM, CALCIUM GLUCONATE, L-ARGININE, L-CARNITINE, L-ORNITHINE, MAGNESIA MURIATICA, MAGNESIUM GLUCONICUM DIHYDRICUM, MANGANESE GLUCONATE, NATRUM MURIATICUM, COBALT GLUCONATE, COPPER GLUCONATE, CREATINE, L-GLUTAMINE, L-LEUCINE, L-VALINE, POTASSIUM GLUCONATE, SELENIUM DIOXIDE, ADRENALINUM, BORON, CALCAREA PHOSPHORICA, FERRUM SULPHURICUM, MOLYBDENUM, NICCOLUM METALLICUM, SELENIUM METALLICUM,Energique, Inc.8ca76872-a187-4fd8-8daf-9ee351bdf3462025-01-28WarningsExact identifier
unii: 451W47IQ8X
WHP HeadacheATROPA BELLADONNA - BRYONIA ALBA ROOT - SODIUM CHLORIDE - STRYCHNOS NUX-VOMICA SEEDWashington Homeopathic Products06d25564-4c7e-0b3a-e063-6294a90a38bf2025-01-28WarningsExact identifier
unii: 451W47IQ8X
Fever-InfectionCHAMOMILLA, ECHINACEA HYDRASTIS CANADENSIS, ACONITUM NAPELLUS, ARSENICUM ALBUM, BELLADONNA, BRYONIA, CAMPHORA, CINA, CINCHONA OFFICINALIS, EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENS, HEPAR SULPHURIS CALCAREUM, IGNATIA AMARA, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, PULSATILLA, SALIX NIGRA, VERATRUM VIRIDE, INFLUENZINUMNewton Laboratories, Inc.9d762268-8c30-8a86-e053-2a95a90a419c2025-01-27WarningsExact identifier
unii: 451W47IQ8X
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEAsclemed USA, Inc.65b0b2e2-37fd-4d08-9674-954d62bb531a2025-01-27Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
Histastat PollenBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), ADRENALINUM, ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, NATRUM MURIATICUM, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS, PULSATILLA (PRATENSIS), SABADILLA, SINAPIS NIGRA, SOLIDAGO VIRGAUREA, SULPHUR, WYETHIA HELENIOIDESEnergique, Inc.5a94659f-b62a-41d8-81c0-87a68c02606d2025-01-27WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BM59CALC CARB, DULCAMARA, HEPAR SULPH, LYCOPODIUM, NAT MUR, SULPHUR, THUJA OCCBestmade Natural Products2c763956-a1de-c8df-e063-6294a90a5c812025-01-24WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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