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 10 of 64 · 1,279 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Reflux AwayABIES NIGRA, ANTIMONIUM CRUDUM, ARGENTUM NITRICUM, CARBO VEGETABILIS, CHELIDONIUM MAJUS, COLOCYNTHIS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICANaturalCare8a00a72f-60df-4477-b7b8-abb6355e34da2026-03-24WarningsExact identifier
unii: 451W47IQ8X
OndansetronONDANSETRONJVET PHARMACEUTICALS LLC95ca0d81-a0a8-441d-820e-cb6624018a152026-03-23Warnings, Adverse reactionsExact identifier
rxcui: 283504
unii: NMH84OZK2B
Worafy Gentle Eye WashSODIUM CHLORIDEShenzhen Shandian Jingling Technology Co., Ltd.4da864dc-e10c-1db9-e063-6394a90a09842026-03-22WarningsExact identifier
unii: 451W47IQ8X
OndansetronONDANSETRONREMEDYREPACK INC.36592150-7e19-474c-9f96-cc8341e28b5d2026-03-20Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
SODIUM CHLORIDE HYPERTONICITYSODIUM CHLORIDEYYBA CORP439653b9-99b8-4799-8d67-4a2ada9c67832026-03-20WarningsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Altachlore Sodium Chloride Hypertonicity Ophthalmic 5 PercentSODIUM CHLORIDEAltaire Pharmaceuticals Inc.e13fd053-9420-490c-a43e-e14b0930cb4e2026-03-18WarningsExact identifier
unii: 451W47IQ8X
UniversaltoxALFALFA, AVENA SATIVA, FUCUS VESICULOSUS, HORDEUM VULGARE, NASTURTIUM AQUATICUM, RAPHANUS SATIVUS, TRITICUM AESTIVUM, IODIUM, UBIDECARENONUM, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, MANGANESE GLUCONATE, ORYZA SATIVA, THYROIDINUM (SUIS), CALCAREA CARBONICA, NATRUM MURIATICUM, PULSATILLA (PRATENSIS), RHUS TOX, CORTISONE ACETICUMBioActive Nutritional, Inc.ad454e8a-4f78-4aac-90d9-a3f26a6fbe422026-03-17WarningsExact identifier
unii: 451W47IQ8X
TINTED SUNSCREEN FOUNDATIONTINTED SUNSCREEN FOUNDATIONGuanghzou AiXin Biotech Co Ltd396393c4-b50c-3877-e063-6294a90a0e9b2026-03-17WarningsExact identifier
unii: 059QF0KO0R
BM BIO27CALC PHOS, KALI PHOS, NAT MURBM Private Limited4d229815-05f4-27c5-e063-6394a90ac8652026-03-16WarningsExact identifier
unii: 451W47IQ8X
BM BIO1CALC PHOS, FERR PHOS, KALI PHOS, NAT MURBM Private Limited4d265d99-fdbb-5efb-e063-6394a90a89ac2026-03-16WarningsExact identifier
unii: 451W47IQ8X
BM BIO16CALC PHOS, FERR PHOS, KALI PHOS, MAG PHOS, NAT MUR.BM Private Limited4d26b4a9-ee27-6915-e063-6294a90a5d4d2026-03-16WarningsExact identifier
unii: 451W47IQ8X
BM BIO12FERR PHOS, KALI PHOS, MAG PHOS, NAT MUR.BM Private Limited4d2747ad-958e-63a1-e063-6294a90aea662026-03-16WarningsExact identifier
unii: 451W47IQ8X
RESP EASESODIUM CHLORIDEVenture Healthcare Ltd31b812c9-fb0a-5ee0-e063-6294a90a03e12026-03-16WarningsExact identifier
unii: 451W47IQ8X
RESP EASESODIUM CHLORIDEVenture Healthcare Ltd31b88e7c-eca0-5540-e063-6294a90a1b182026-03-16WarningsExact identifier
unii: 451W47IQ8X
RESP EASESODIUM CHLORIDEVenture Healthcare Ltd31b8c3f4-e528-c69d-e063-6294a90a5a342026-03-16WarningsExact identifier
unii: 451W47IQ8X
RESP EASESODIUM CHLORIDELaboratoire Unither31b7eb13-39c3-6f0e-e063-6394a90a40112026-03-16WarningsExact identifier
unii: 451W47IQ8X
RESP EASESODIUM CHLORIDELaboratoire Unither31b8bb9c-d30f-152f-e063-6394a90a52082026-03-16WarningsExact identifier
unii: 451W47IQ8X
RESP EASESODIUM CHLORIDELaboratoire Unither31b8dcbd-9e6b-1edc-e063-6394a90aac732026-03-16WarningsExact identifier
unii: 451W47IQ8X
BM BIO20CALC FLUOR, CALC SULF, KALI SULF, NAT MUR, NAT SULFBM Private Limited4d285396-9df8-86bc-e063-6294a90ad4de2026-03-16WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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