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 25 of 63 · 1,244 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Polyethylene Glycol 3350 and electrolytes - UnflavoredPOLYETHYLENE GLYCOL 3350 AND ELECTROLYTES - UNFLAVOREDStrides Pharma Science Limited48c741a9-9039-4fdb-a875-86d4ea9682822025-09-05Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEPreferred Pharmaceuticals Inc.36d64400-2d13-4a1a-a1ca-4741cd3d3f1a2025-09-03Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
OndansetronONDANSETRONNorthStar Rx LLC9d5e7650-95be-4b96-b29c-374f673eb7a12025-09-03Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDERising Pharma Holdings, Inc.90e0e508-75f7-4c8b-bb38-898aa4c531c32025-09-01Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride - UnflavoredPOLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDE - UNFLAVOREDStrides Pharma Science Limited37c111ec-5b62-42b9-bbb2-3b0c530e34c92025-09-01Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sterile WaterWATER INJECTIONHenry Schein, Inc.3501952b-b556-4d5e-b81b-5c35ff87b4752025-08-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ONDANSETRONONDANSETRONProPharma Distribution3d5d25eb-8711-ef8c-e063-6394a90a5e032025-08-27Warnings, Adverse reactionsExact identifier
rxcui: 1740467
unii: NMH84OZK2B
ONDANSETRONONDANSETRONApotex Corp.2c68d202-fdf7-4b6a-dd7f-82624fcdbd4a2025-08-26Warnings, Adverse reactionsExact identifier
rxcui: 1740467
unii: NMH84OZK2B
Dextrose and Sodium ChlorideDEXTROSE AND SODIUM CHLORIDEBaxter Healthcare Companydcbf1907-1841-4afc-ab5d-a9893a2d72562025-08-26Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
terrasil Fast and Natural Wart RemovalGRAPHITE 10X, NATRUM MURIATICUM 3X, SYMPHYTUM OFFICINALE (COMFREY) 1X, THUJA OCCIDENTALIS 3XAidance Scientific, Inc.3d367c0f-5a28-eded-e063-6394a90ad2dc2025-08-25WarningsExact identifier
unii: 451W47IQ8X
Cold Sore Treatment Extra StrengthECHINACEA ANGUSTIFOLIA WHOLE, SODIUM CHLORIDE, THUJA OCCIDENTALIS LEAFY TWIG, AND CALENDULA OFFICINALIS FLOWERING TOPForces of Nature0a5d32dc-c0e7-404e-85f2-6c3a338560ba2025-08-22WarningsExact identifier
unii: 451W47IQ8X
IncontinenceALOE, ARG. NIT., ARSENICUM ALB., BELLADONNA, BENZOICUM ACIDUM, BRYONIA, CANTHARIS, CAUSTICUM, EQUISETUM HYEMALE, FERRUM METALLICUM, GELSEMIUM, IGNATIA, KALI PHOS., LYCOPODIUM, NAT. MUR., NITRICUM AC., PLANTAGO, PULSATILLA, RHUS AROMATICA , SABAL, SECALE, SEPIA, STAPHYSAG.,STRAMONIUM, THYROIDINUM, VERBASCUM, ECHINACEA, HYDRASTISNewton Laboratories, Inc.994cbc8e-a221-1548-e053-2995a90a1f7f2025-08-20WarningsExact identifier
unii: 451W47IQ8X
Medique Medi SeltzerASPIRIN, CITRIC ACID, SODIUM BICARBONATEUnifirst First Aid Corporation528da9d9-2a52-4c16-b7b2-61b3eee1abea2025-08-19WarningsExact identifier
unii: 2968PHW8QP
Jacksons Cell Salts NAT MUR 6X 9NATRUM MURIATICUMZettl Health Inc.3cbe47fc-db38-e6e9-e063-6294a90a3f1c2025-08-19WarningsExact identifier
unii: 451W47IQ8X
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.426ba54f-199a-41d1-8c27-f827bea568542025-08-15Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
QUALITY CHOICE SALINESODIUM CHLORIDEQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)f51491d8-12ad-4b1b-a171-c621bfdcc3412025-08-12WarningsExact identifier
unii: 451W47IQ8X
OndansetronONDANSETRON HYDROCHLORIDENorthStar Rx LLCac3dfb81-a4c7-4147-9374-c234153b7c512025-08-11Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
Sodium ChlorideSODIUM CHLORIDEHenry Schein, Inc.e0466bb3-6c26-4044-b051-69f48b67f6322025-08-07Adverse reactionsExact identifier
unii: 451W47IQ8X
Schuessler Tissue Salts Nat Mur Fluid Balance 9NATRUM MURIATICUMMartin & Pleasance Pty Ltd08da6353-9625-4e8f-8575-a2b49f5d2ac62025-08-04WarningsExact identifier
unii: 451W47IQ8X
Gout Relief 3310-SCELERY SEED, MEDICAGO SATIVA WHOLE,CHICORY ROOTBispit Canada Ltd.3afaa7d9-3de3-52d9-e063-6294a90a54ec2025-08-02WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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