FDA.reportPublic FDA data

NDC 0641-6078-01 - 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
0641-6078
Requested NDC
0641-6078-01
Package NDCs from labels
0641-6078-01, 0641-6078-25
Manufacturer
Cardinal Health 107, LLC
Effective date
2026-10-12
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, LLC2026-10-12HUMAN PRESCRIPTION DRUG LABEL
Ondansetron - Hikma Pharmaceuticals USA Inc.Hikma Pharmaceuticals USA Inc.2026-04-09HUMAN PRESCRIPTION DRUG LABEL
ONDANSETRON - HF Acquisition Co LLC, DBA HealthFirstHF Acquisition Co LLC, DBA HealthFirst2024-02-22HUMAN PRESCRIPTION DRUG LABEL
Ondansetron - Medical Purchasing Solutions, LLCMedical Purchasing Solutions, LLC2023-05-16HUMAN 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
0641-6078-01Ondansetron2 mL in 1 VIALINJECTION217
0641-6078-25Ondansetron25 in 1 CARTONINJECTION2517

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6078ONDANSETRON INJECTION [HIKMA PHARMACEUTICALS USA INC.]16Current NDC, Legacy NDC, 2 package rows20240411_c29ca6df-621d-44b6-98fc-b48666573366.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6078-01ML - Milliliter0641-60789c323cc7-6ae6-410e-9b37-49f2dba2882512012-07-24
0641-6078-25ML - Milliliter0641-60786303a3b5-0d5c-4f77-840a-dcf4dfa8972412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ONDANSETRON HYDROCHLORIDEACTIVE INGREDIENTNMH84OZK2BONDANSETRON INJECTION [WEST-WARD PHARMACEUTICAL CORP.]11
ONDANSETRONACTIVE MOIETY4AF302ESOSONDANSETRON INJECTION [WEST-WARD PHARMACEUTICAL CORP.]11
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPONDANSETRON INJECTION [WEST-WARD PHARMACEUTICAL CORP.]11
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TONDANSETRON INJECTION [WEST-WARD PHARMACEUTICAL CORP.]11
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHONDANSETRON INJECTION [WEST-WARD PHARMACEUTICAL CORP.]11
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XONDANSETRON INJECTION [WEST-WARD PHARMACEUTICAL CORP.]11
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KONDANSETRON INJECTION [WEST-WARD PHARMACEUTICAL CORP.]11
WATERINACTIVE INGREDIENT059QF0KO0RONDANSETRON INJECTION [WEST-WARD PHARMACEUTICAL CORP.]11
ONDANSETRON HYDROCHLORIDEACTIVE INGREDIENTNMH84OZK2BONDANSETRON INJECTION [CARDINAL HEALTH]4
ONDANSETRONACTIVE MOIETY4AF302ESOSONDANSETRON INJECTION [CARDINAL HEALTH]4
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPONDANSETRON INJECTION [CARDINAL HEALTH]4
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XONDANSETRON INJECTION [CARDINAL HEALTH]4
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KONDANSETRON INJECTION [CARDINAL HEALTH]4
WATERINACTIVE INGREDIENT059QF0KO0RONDANSETRON INJECTION [CARDINAL HEALTH]4

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 34 of 60 · 1,189 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
N-14FUCUS VESICULOSUS, SODIUM CHLORIDE, LYCOPUS VIRGINICUS, SPONGIA OFFICINALIS SKELETON, ROASTED, POTASSIUM IODIDE, CALCIUM IODIDE, THYROID, UNSPECIFIED, BOS TAURUS ADRENAL GLAND, BOS TAURUS PITUITARY GLAND, POSTERIOR, BOS TAURUS THYMUS, AND SUS SCROFA SPLEENDNA Labs, Inc.3d64739c-5d61-4e88-8612-d5f6994f1c3c2025-01-09WarningsExact identifier
unii: 451W47IQ8X
N-24METABOLINDNA Labs, Inc.559fca2b-1093-4bdf-be70-c453f87002c32025-01-09WarningsExact identifier
unii: 451W47IQ8X
T-27WATERDNA Labs, Inc.f0e9afd7-64a4-4b85-9c5f-4bf07ba4b4812025-01-09WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterSTERILE WATER FOR INJECTIONMedefil, Inc.99e99a50-82d5-aff6-e053-2a95a90a8c562025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BACTERIOSTATIC WATERBACTERIOSTATIC WATERHF Acquisition Co LLC, DBA HealthFirst99b0ef9b-600a-40dc-e053-2a95a90aa07e2025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
0.9% SODIUM CHLORIDE0.9% SODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirst8dfb05c0-77e8-2fa1-e053-2a95a90a3d332025-01-08Adverse reactionsExact identifier
unii: 451W47IQ8X
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst99b1cb12-0b2d-0c0f-e053-2a95a90ac3b62025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ONDANSETRONONDANSETRONHF Acquisition Co LLC, DBA HealthFirst99ac0a5e-dd2a-4352-e053-2a95a90a68fd2025-01-08Warnings, Adverse reactionsExact identifier
rxcui: 1740467
unii: NMH84OZK2B
SODIUM CHLORIDESODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirst998a2a47-5c79-2efd-e053-2995a90a8fac2025-01-08Adverse reactionsExact identifier
unii: 451W47IQ8X
SODIUM CHLORIDESODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirst7da788fc-3481-527f-e053-2a91aa0af6ac2025-01-08Adverse reactionsExact identifier
unii: 451W47IQ8X
Emetrol Powder Non-DrowsySODIUM CITRATE DIHYDRATEWellSpring Pharmaceutical Corporation9d8d2ee7-9db7-4be7-8c73-511eb2e324592025-01-08WarningsExact identifier
unii: B22547B95K
Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE AND SODIUM CHLORIDEBECTON DICKINSON AND COMPANYc1d0f42e-3494-4217-8f86-e9f34d930e822025-01-07Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Shingles RemedyCROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLASilver Star Brands5d65c997-f5dc-4dee-e053-2a91aa0ac3192025-01-01WarningsExact identifier
unii: 451W47IQ8X
Mucus Clear Allergy ReliefALLIU CEPA, CALC PHOS, EUPHRASIA, IGNATIA, KALI MUR, NAT MUR, NUX VOM, PULSATILLA, SILICASilver Star Brandsf49bdcc1-1939-6dc2-e053-2995a90a0a3b2025-01-01WarningsExact identifier
unii: 451W47IQ8X
Sweat-LessARG NIT, CASTOREUM, HUMULUS, IODUM, KALI PHOS, NAT MURSilver Star Brands4053d10b-4b06-291b-e054-00144ff88e882025-01-01WarningsExact identifier
unii: 451W47IQ8X
NativeRemedies Triple Complex Brain TonicCALC PHOS, KALI PHOS, NAT MUR.Silver Star Brandsf76eaf46-4a80-31a9-e053-6394a90a542d2025-01-01WarningsExact identifier
unii: 451W47IQ8X
Headache EaseAUR MET, BELLADONNA, BRYONIA, GELSEISUM, IGNATIA, KALI PHOS, NAT MUR, NUX VOM, SEPIASilver Star Brandsc689fb16-6200-ac94-e053-2995a90a703d2025-01-01WarningsExact identifier
unii: 451W47IQ8X
AllergiClear-MADRENALINUM, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, KALI MURIATICUM, NATRUM MURIATICUM, SILICEASilver Star Brands9d36096b-022f-5cfa-e053-2995a90a381f2025-01-01WarningsExact identifier
unii: 451W47IQ8X
DG Health Sterile Saline MistSODIUM CHLORIDEDG Healthf2e44ab4-ae0f-c87b-e053-2a95a90acd042024-12-31WarningsExact identifier
unii: 451W47IQ8X
Ondansetron HCLONDANSETRON HCLAdvanced Rx of Tennessee, LLCaf75407e-82aa-136f-e053-2995a90a429b2024-12-31Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B

Reported adverse events (FAERS/openFDA)#

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