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 27 of 60 · 1,189 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
EXTRANEAL	ICODEXTRIN, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE	Vantive US Healthcare LLC	d5b85158-b0d6-4855-9d07-8d1b3ad9ab71	2025-06-30	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
ONDANSETRON	ONDANSETRON HYDROCHLORIDE	Dr. Reddy's Laboratories Limited	162f2088-9fb1-47e7-b88c-45104be7e7bb	2025-06-30	Warnings, Adverse reactions	Exact identifier unii: NMH84OZK2B
ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	Baxter Healthcare Corporation	729d865f-d84a-495e-9456-4bceebb6e03f	2025-06-30	Warnings, Adverse reactions	Exact identifier rxcui: 283504 rxcui: 1740467 unii: NMH84OZK2B
SODIUM CHLORIDE	SODIUM CHLORIDE	Baxter Healthcare Corporation	958d35f0-6834-43be-a700-fa58f38b4c19	2025-06-30	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
InterSol	PLATELET ADDITIVE 3	Fenwal, Inc.	17dec820-1b57-4ac9-82a8-419cab664a2f	2025-06-27	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X unii: B22547B95K
Nauzene Chewables Ginger Honey	SODIUM CITRATE	Kobayashi Healthcare International, Inc.	25c9825d-a4e8-4671-e063-6294a90ab46d	2025-06-24	Warnings	Exact identifier unii: B22547B95K
Ondansetron	ONDANSETRON	Cardinal Health 107, LLC	ee1f115f-c8f8-4526-b827-c8e48aeb5050	2025-06-20	Warnings, Adverse reactions	Exact identifier application number: ANDA077541 rxcui: 1740467 unii: NMH84OZK2B
Plaque identifying	PLAQUE IDENTIFYING	Shenzhen Yagao Technology Co., Ltd.	37eeb656-22f1-7372-e063-6394a90ad041	2025-06-19	Warnings	Exact identifier unii: 059QF0KO0R
ondansetron hydrochloride	ONDANSETRON HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	92c758a3-e749-4a15-be4b-ee30b364b2b0	2025-06-12	Warnings, Adverse reactions	Exact identifier unii: NMH84OZK2B
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	1a0c4dc6-643e-4ee7-92a9-edb98049a5ba	2025-06-09	Warnings, Adverse reactions	Exact identifier unii: NMH84OZK2B
HAIR STIM	PEDICULUS CAPITIS, THYROIDINUM (SUIS), BARYTA CARBONICA, BORAX, CALCAREA CARBONICA, CINCHONA OFFICINALIS, GLANDULA SUPRARENALIS SUIS, HYDROFLUORICUM ACIDUM, MERCURIUS SOLUBILIS, MEZEREUM, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SEPIA, SILICEA, SULPHUR, THUJA OCCIDENTALIS, VINCA MINOR	The Wellness Center for Research and Education, Inc.	8ecc05ff-ed5a-4157-9100-1c7912686f07	2025-06-06	Warnings	Exact identifier unii: 451W47IQ8X
MBM 7 Lung	COCCUS CACTI, LUNG (SUIS), IGNATIA AMARA, CAUSTICUM, NATRUM MURIATICUM	The Wellness Center for Research and Education, Inc.	6eb49fb5-485c-4b48-b231-4db88ebe20df	2025-06-04	Warnings	Exact identifier unii: 451W47IQ8X
PRISMASOL BGK2/0	MAGNESIUM CHLORIDE, DEXTROSE ANHYDROUS, LACTIC ACID, SODIUM CHLORIDE, SODIUM BICARBONATE, AND POTASSIUM CHLORIDE	Vantive US Healthcare LLC	7f675fee-8940-4ece-bb0c-75ac79d8708c	2025-05-31	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Precision Dose Inc.	04800a86-2391-44e6-8763-d65e8a916c26	2025-05-30	Warnings, Adverse reactions	Exact identifier unii: NMH84OZK2B
Sterile Water	WATER	Henry Schein, Inc.	88403fcf-a276-42c0-88b6-bd84a720b564	2025-05-29	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Ondansetron	ONDANSETRON	ATLANTIC BIOLOGICALS CORP.	e5ab38a2-5921-4320-a313-e0080c078046	2025-05-28	Warnings, Adverse reactions	Exact identifier unii: NMH84OZK2B
Resentment	ADRENALINUM, AMMONIUM MURIATICUM, APOCYNUM CANNABINUM, BUTHUS AUSTRALIS, CARDUUS MARIANUS, CINCHONA OFFICINALIS, FEL TAURI, HEPAR SUIS, HEPAR SULPHURIS CALCAREUM, HYPOTHALAMUS SUIS, MANGANUM CARBONICUM, MOSCHUS, NAJA TRIPUDIANS, NATRUM MURIATICUM, NITRICUM ACIDUM, NUX VOMICA, RHUS TOX, TARAXACUM OFFICINALE	Deseret Biologicals, Inc.	d397ed9c-10f0-4a99-baca-a31e5e18572a	2025-05-27	Warnings	Exact identifier unii: 451W47IQ8X
Virimmune	ACONITUM NAPELLUS, ALLIUM CEPA, ALLIUM SATIVUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, CHELIDONIUM MAJUS, ECHINACEA (ANGUSTIFOLIA), GELSEMIUM SEMPERVIRENS, GINKGO BILOBA, HAMAMELIS VIRGINIANA, INFLUENZINUM (2023-2024), MERCURIUS VIVUS, MORBILLINUM, NATRUM MURIATICUM, NUX VOMICA, SELENIUM METALLICUM, VISCUM ALBUM	Deseret Biologicals, Inc.	1d35a8ab-c06b-478d-8f7b-dbe9c7dbb3d4	2025-05-27	Warnings	Exact identifier unii: 451W47IQ8X
Insecticides/Pest/Food Additives Detox	BOLDO, CARDUUS MARIANUS, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM	Dr. Donna Restivo DC	b5778211-0e3e-44ef-bd65-a76a68cf1504	2025-05-23	Warnings	Exact identifier unii: Z8IX2SC1OH unii: A2I8C7HI9T
MetDetox	ALLIUM SATIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, ASCORBICUM ACIDUM, CYSTEINUM, L-METHIONINE, PHYTOLACCA DECANDRA, THYROIDINUM (SUIS), CARBOLICUM ACIDUM, FORMALINUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, BORON, ARSENICUM ALBUM, MERCURIUS SOLUBILIS, PLUMBUM METALLICUM, LANTHANUM METALLICUM, NIOBIUM METALLICUM, TANTALUM METALLICUM, ALUMINIUM METALLICUM, ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, ARSENICUM ALBUM, AURUM METALLICUM,	Dr. Donna Restivo DC	89ce5e89-c592-445e-92f9-365133005fb3	2025-05-23	Warnings	Exact identifier unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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