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
Label	Manufacturer	Effective date	Type
Ondansetron - Cardinal Health 107, LLC	Cardinal Health 107, LLC	2026-10-12	HUMAN PRESCRIPTION DRUG LABEL
Ondansetron - Hikma Pharmaceuticals USA Inc.	Hikma Pharmaceuticals USA Inc.	2026-04-09	HUMAN PRESCRIPTION DRUG LABEL
ONDANSETRON - HF Acquisition Co LLC, DBA HealthFirst	HF Acquisition Co LLC, DBA HealthFirst	2024-02-22	HUMAN PRESCRIPTION DRUG LABEL
Ondansetron - Medical Purchasing Solutions, LLC	Medical Purchasing Solutions, LLC	2023-05-16	HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unit	National Council for Prescription Drug Programs	2012-07-24	Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0641-6078-01	Ondansetron	2 mL in 1 VIAL	INJECTION	2		17
0641-6078-25	Ondansetron	25 in 1 CARTON	INJECTION	25		17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0641-6078	ONDANSETRON INJECTION [HIKMA PHARMACEUTICALS USA INC.]	16	Current NDC, Legacy NDC, 2 package rows	20240411_c29ca6df-621d-44b6-98fc-b48666573366.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0641-6078-01	ML - Milliliter	0641-6078	9c323cc7-6ae6-410e-9b37-49f2dba28825	1	2012-07-24
0641-6078-25	ML - Milliliter	0641-6078	6303a3b5-0d5c-4f77-840a-dcf4dfa89724	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ONDANSETRON HYDROCHLORIDE	ACTIVE INGREDIENT	NMH84OZK2B	ONDANSETRON INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	11
ONDANSETRON	ACTIVE MOIETY	4AF302ESOS	ONDANSETRON INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	11
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	ONDANSETRON INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	11
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	ONDANSETRON INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	11
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	ONDANSETRON INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	11
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	ONDANSETRON INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	11
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	ONDANSETRON INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	11
WATER	INACTIVE INGREDIENT	059QF0KO0R	ONDANSETRON INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	11
ONDANSETRON HYDROCHLORIDE	ACTIVE INGREDIENT	NMH84OZK2B	ONDANSETRON INJECTION [CARDINAL HEALTH]	4
ONDANSETRON	ACTIVE MOIETY	4AF302ESOS	ONDANSETRON INJECTION [CARDINAL HEALTH]	4
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	ONDANSETRON INJECTION [CARDINAL HEALTH]	4
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	ONDANSETRON INJECTION [CARDINAL HEALTH]	4
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	ONDANSETRON INJECTION [CARDINAL HEALTH]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	ONDANSETRON 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 58 of 59 · 1,172 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Skin Klear Acne Relief	TRIBASIC CALCIUM PHOSPHATE, FUMARIA OFFICINALIS FLOWERING TOP, ARCTIUM LAPPA ROOT, SODIUM CHLORIDE, SAPONARIA OFFICINALIS ROOT, SILICON DIOXIDE, SOLIDAGO VIRGAUREA FLOWERING TOP, SULFUR, VIOLA TRICOLOR	Homeocare Laboratories	65afbc20-611b-4bc4-a151-c633bec66a82	2018-12-31	Warnings	Exact identifier unii: 451W47IQ8X
H.M.D.	ALLIUM SAT, AVENA, BERBER VULG, LAPPA, PHYTOLACCA, SOLIDAGO, ALUMINA, ARG NIT, BARYTA CARB, BERYLLIUM, CADMIUM MET, CURPRUM MET, FLUORICUM ACIDUM, INDIUM, IODIUM, LITHIUM CARB, MERC SOLUB, NICCOLUM CARB, NITROGENUM OXYGENATUM, PLUMB MET, SELENIUM, STRONTIUM CARB, TITANIUM, ARSENICUM ALB, NAT MUR, NUX VOM	Zorex International	8c53091a-904d-4756-93e4-17143c5b48e9	2018-12-21	Warnings	Exact identifier unii: 451W47IQ8X
GUNA-ALLERGY-PREV	AMBROSIA ARTEMISIIFOLIA - ANGUILLA ROSTRATA BLOOD SERUM - ARUNDO PLINIANA ROOT - BLACK CURRANT - CHELIDONIUM MAJUS - CITRIC ACID MONOHYDRATE - HISTAMINE DIHYDROCHLORIDE - HUMAN INTERLEUKIN 12 - INTERFERON GAMMA-1B - MANGANESE GLUCONATE - PARIETARIA OFFICINALIS - PHLEUM PRATENSE - SODIUM PYRUVATE - SODIUM SULFATE - SUCCINIC ACID - SULFUR - URTICA URENS - VIBURNUM OPULUS ROOT - WYETHIA HELENIOIDES ROOT -	Guna spa	adae93c0-1de9-4e45-ab58-148171f0dc86	2018-12-21	Warnings	Exact identifier unii: 2968PHW8QP
Vitality Female	ARALIA QUINQUEFOLIA, AVENA SATIVA, BERBERIS VULGARIS, CAUSTICUM, GRAPHITES, LACHESIS MUTUS, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SEPIA	Natural Creations, Inc	679ba86d-bf84-4ded-b0bf-d55a0df9faa4	2018-12-21	Warnings	Exact identifier unii: 451W47IQ8X
Hydrate II	BERBER AQUI, BETA VULG, BOLDO, CARDUUS MAR, CHELIDONIUM MAJ, HORDEUM VULGARE, IRIS VERS, ROSMARINUS, TARAXACUM, AVENA, ELEUTHEROCOCCUS SENTICOSUS, XANTHOXYLUM, EQUISETUM HYEM, HYPERICUM, ULMUS FULV, GETTYSBURG AQUA, GLYCYRRHIZA, WILDBAD AQUA, CARLSBAD AQUA, ATP, HYDROGEN, NAT MUR, OXYGEN, SILICEA, WIESBADEN AQUA	Zorex International	e5f53495-3b75-4d7c-89af-23058fb6fd05	2018-12-21	Warnings	Exact identifier unii: 451W47IQ8X
Dynamic Eyewash with Eyecup	WATER	Dynamic Safety International	7d3af0f4-0e1f-9ea5-e053-2991aa0af7a2	2018-12-17	Warnings	Exact identifier unii: 059QF0KO0R
Ondansetron	ONDANSETRON	West-Ward Pharmaceuticals Corp	bb4bc810-db26-471b-9ce7-6e2fb3018af0	2018-12-14	Warnings, Adverse reactions	Exact identifier rxcui: 283504 rxcui: 1740467 unii: NMH84OZK2B
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	08db5ce7-4dcf-4581-a0bf-f405cc22b48d	2018-08-27	Warnings, Adverse reactions	Exact identifier unii: NMH84OZK2B
WinCo Foods Saline Nasal Relief	SODIUM CHLORIDE	WinCo Foods, LLC	1280fee4-e763-49ba-8722-8cdb8157f1a4	2018-08-02	Warnings	Exact identifier unii: 451W47IQ8X
Bio Rock Water	ROCK WATER	BioActive Nutritional, Inc.	178bd16d-0d4f-49d8-866b-8ab3a3c6889d	2018-07-30	Warnings	Exact identifier unii: 059QF0KO0R
Additox	TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BELLADONNA, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM	BioActive Nutritional, Inc.	319ee2fe-58e3-495e-bf0d-df201f6fbb1c	2018-07-18	Warnings	Exact identifier unii: Z8IX2SC1OH unii: A2I8C7HI9T
Sodium Chloride	SODIUM CHLORIDE	Baxter Healthcare Corporation	05dee566-7b82-4216-8a6b-765d2b4d9dc7	2018-07-17	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
HA HP	BELLADONNA, BRYONIA (ALBA), GELSEMIUM SEMPERVIRENS, GLONOINUM, MELILOTUS OFFICINALIS, NUX VOMICA, SILICEA, SPIGELIA ANTHELMIA	BioActive Nutritional, Inc.	30f6c191-ce6e-438c-9601-74f5e8b61f96	2018-07-06	Warnings	Exact identifier unii: 451W47IQ8X
Metabolic Support	FUCUS VESICULOSUS, AGNUS CASTUS, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, PHYTOLACCA DECANDRA, KALI PHOSPHORICUM, MAGNESIA PHOSPHORICA, CARBO VEGETABILIS, GRAPHITES, CALCAREA CARBONICA, NATRUM PHOSPHORICUM, HYPOPHYSIS SUIS, PLACENTA TOTALIS SUIS, THYROIDINUM (SUIS)	BodyLogicMD of Fort Lauderdale	c2a1bd6d-c595-402f-a3bc-23f64c949d78	2018-06-08	Warnings	Exact identifier unii: 451W47IQ8X
Sodium Chloride	SODIUM CHLORIDE	Baxter Healthcare Corporation	181705c7-40e4-4d7d-b9ea-ada99380e7a9	2018-05-23	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Sodium Chloride	SODIUM CHLORIDE	Baxter Healthcare Corporation	7c72520e-de3c-493d-8aea-11933376d968	2018-04-02	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Lactated Ringers	SODIUM CHLORIDE, SOLDIUM LACTATE, POTASSIUM CHLORIDE AND CALCIUM CHLORIDE	Baxter Healthcare Company	5215ec33-8cfe-4885-ae92-e6a12100bd27	2018-01-02	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Homeoplex B	ARSENICUM ALBUM, CALCAREA CARBONICA , IGNATIA AMARA, KALI CARBONICUM, LACHESIS MUTUS, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA, STAPHYSAGRIA	Supplement Clinic, LLC.	e9a9c58e-1b70-4ac8-9d9c-108c628d7664	2017-10-31	Warnings	Exact identifier unii: 451W47IQ8X
Spleen-Pro T018	SPLEEN (SUIS), ARSENICUM ALBUM, CARBO VEGETABILIS, CEANOTHUS AMERICANUS, CHININUM SULPHURICUM, IGNATIA AMARA, IODIUM, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORICUM ACIDUM, PHOSPHORUS	Guangzhou Renuma Medical Systems Co., Ltd	bc2b70bd-2a4a-46fb-b3d8-d69b61056b89	2017-10-26	Warnings	Exact identifier unii: 451W47IQ8X
Female Vitality T010	CIMICIFUGA RACEMOSA, FUCUS VESICULOSUS, OOPHORINUM (SUIS), HYPOPHYSIS SUIS, THYROIDINUM (SUIS), GRAPHITES, LACHESIS MUTUS, NATRUM MURIATICUM, PULSATILLA (PRATENSIS), SEPIA	Guangzhou Renuma Medical Systems Co., Ltd	694f0c36-b656-471a-9f38-2efb5193e05a	2017-10-20	Warnings	Exact identifier unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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