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: Hikma Pharmaceuticals USA Inc.
Effective date: 2026-04-09
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Ondansetron - Hikma Pharmaceuticals USA Inc.	Hikma Pharmaceuticals USA Inc.	2026-04-09	HUMAN PRESCRIPTION DRUG LABEL
Ondansetron - Cardinal Health 107, LLC	Cardinal Health 107, LLC	2025-10-23	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 8 of 63 · 1,244 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DIANEAL Low Calcium with Dextrose	SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE	Vantive US Healthcare LLC	aa268d3f-7389-4f25-801f-5d4825495f08	2026-04-16	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Ondansetron	ONDANSETRON	Hikma Pharmaceuticals USA Inc.	97713356-f42b-4a67-95f6-561afa68c0c2	2026-04-16	Warnings, Adverse reactions	Exact identifier application number: ANDA077541 application number: ANDA077365 rxcui: 283504 rxcui: 1740467 unii: NMH84OZK2B
PEG 3350 and Electrolytes	POLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE	Wilshire Pharmaceuticals, Inc.	b251752d-7750-482a-9364-0acf4ad47cc8	2026-04-16	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Dextrose and Sodium Chloride	DEXTROSE MONOHYDRATE AND SODIUM CHLORIDE	Fresenius Kabi USA, LLC	99c6a1a9-cadf-435b-a332-ccc189afdfa9	2026-04-16	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
GoLYTELY	POLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE	Azurity Pharmaceuticals, Inc.	7609ecf7-0ce0-4fbb-9c27-30987f689575	2026-04-15	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
TRILYTE	POLYETHYLENE GLYOCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDE	Aurobindo Pharma Limited	79f5e596-8d51-4227-afcc-f5e341150957	2026-04-15	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Anxiety Relief	ACONITUM NAPELLUS, ARGENTUM NITRICUM, ARSENICUM ALBUM, AURUM METALLICUM, GELSEMIUM SEMPERVIRENS, HYOSCYAMUS NIGER, IGNATIA AMARA, KALI CARBONICUM, MOSCHUS, NATRUM MURIATICUM, PIPER METHYSTICUM	NaturalCare	9f982e89-655c-49be-85d8-4099a02ed021	2026-04-15	Warnings	Exact identifier unii: 451W47IQ8X
PEG 3350, sodium chloride, sodium bicarbonate and potassium chloride	POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE	Wilshire Pharmaceuticals, Inc.	4e442a72-b13b-4869-8a1d-59356095b091	2026-04-14	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Ondansetron	ONDANSETRON	Sportpharm LLC	98c1413c-ff7f-4554-9e9f-289038b39ca6	2026-04-14	Warnings, Adverse reactions	Exact identifier rxcui: 283504 unii: NMH84OZK2B
Anticoagulant Sodium Citrate	TRISODIUM CITRATE DIHYDRATE	LABORATORIOS GRIFOLS SA	db8334be-5b8b-4811-811a-efbe32b6d147	2026-04-14	Warnings	Exact identifier unii: B22547B95K
SODIUM CHLORIDE 1 GRAM	SODIUM CHLORIDE	Gendose Pharmaceuticals, LLC	ce988ae5-61c6-4324-90e1-a94c8a54d0d0	2026-04-13	Warnings	Exact identifier unii: 451W47IQ8X
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	REMEDYREPACK INC.	5cc67d95-6629-4451-9e34-2f7a60482be5	2026-04-10	Warnings, Adverse reactions	Exact identifier unii: NMH84OZK2B
Quantum Resonance	ALCOHOLUS, ALUMINA SILICATA, ANACARDIUM ORIENTALE, AQUA MARINA, BAPTISIA TINCTORIA, CANDIDA ALBICANS, COLLAGEN, DNA, LAVANDULA OFFICINALIS, MEDULLA OSSIS SUIS, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NUX MOSCHATA, PHOSPHORUS, QUARTZ, SILICEA, TELA ARANEA, VALERIANA OFFICINALIS, VISCUM ALBUM	Deseret Biologicals, Inc.	f94a10bd-1c40-42c7-b458-b58070614549	2026-04-10	Warnings	Exact identifier unii: 451W47IQ8X
Quantum Resonance	ALCOHOLUS, ALUMINA SILICATA, ANACARDIUM ORIENTALE, AQUA MARINA, BAPTISIA TINCTORIA, CANDIDA ALBICANS, COLLAGEN, DNA, LAVANDULA OFFICINALIS, MEDULLA OSSIS SUIS, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NUX MOSCHATA, PHOSPHORUS, QUARTZ, SILICEA, TELA ARANEA, VALERIANA OFFICINALIS, VISCUM ALBUM	Deseret Biologicals, Inc.	1467111a-bef6-473d-b7f2-3309a9bb72ce	2026-04-10	Warnings	Exact identifier unii: 451W47IQ8X
Ondansetron	ONDANSETRON	Hikma Pharmaceuticals USA Inc.	c29ca6df-621d-44b6-98fc-b48666573366	2026-04-09	Warnings, Adverse reactions	Exact identifier application number: ANDA077541 application number: ANDA077365 ndc (package): 0641-6079-01 ndc (package): 0641-6078-25 ndc (package): 0641-6078-01 ndc (product): 0641-6079 ndc (product): 0641-6078 ndc11 (package): 00641607801 rxcui: 283504 rxcui: 1740467 spl id: 9e948e67-37a3-48ca-ae91-a73efea950aa spl set id: c29ca6df-621d-44b6-98fc-b48666573366 unii: NMH84OZK2B
H-Focus Formula	AGNUS CASTUS, AVENA SATIVA, BARYTA CARBONICA, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NATRUM CARBONICUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, SILICEA, ZINCUM METALLICUM	Healing Natural Oils LLC	4ee42911-3064-7f55-e063-6294a90abcc7	2026-04-07	Warnings	Exact identifier unii: 451W47IQ8X
H-Mood Formula	AGRIMONIA EUPATORIA, FLOS, ANACARDIUM ORIENTALE, AURUM METALLICUM, AVENA SATIVA, BORAGO OFFICINALIS, CAPSICUM ANNUUM, CARPINUS BETULUS, FLOS, CIMICIFUGA RACEMOSA, CINCHONA OFFICINALIS, HYPERICUM PERFORATUM, KALI BROMATUM, LARIX DECIDUA, FLOS, NATRUM CARBONICUM, NATRUM MURIATICUM, NATRUM SULPHURICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PULSATILLA, SILICEA, SINAPSIS ARVENSIS, FLOS, TABACUM	Healing Natural Oils LLC	4ee5c82e-9edf-c36e-e063-6394a90a237f	2026-04-07	Warnings	Exact identifier unii: 451W47IQ8X
Sodium Citrate and Citric Acid	SODIUM CITRATE AND CITRIC ACID	Chartwell Governmental & Specialty RX, LLC	58c24504-47de-487a-ab8d-18add155ea95	2026-04-07	Adverse reactions	Exact identifier unii: 2968PHW8QP
Walgreens Sodium Chloride Ophthalmic 5 Percent Hypertonicity Eye	SODIUM CHLORIDE	Walgreen Company	bda3b9db-5fc4-408c-a5ae-d1eeb3ee308d	2026-04-06	Warnings	Exact identifier unii: 451W47IQ8X
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Sportpharm LLC	b1324076-f83e-4816-9e02-6b2a689010bc	2026-04-05	Warnings, Adverse reactions	Exact identifier unii: NMH84OZK2B

Reported adverse events (FAERS/openFDA)#

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