NDC 0641-6080-01 - 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: 0641-6080
Requested NDC: 0641-6080-01
Package NDCs from labels: 0641-6080-01, 0641-6080-25
Manufacturer: Hikma Pharmaceuticals USA Inc.
Effective date: 2026-04-16
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.	2026-04-16	HUMAN PRESCRIPTION DRUG LABEL
Ondansetron - Cardinal Health 107, LLC	Cardinal Health 107, LLC	2025-06-20	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
0641-6080-01	Ondansetron	2 mL in 1 VIAL	INJECTION	2		20
0641-6080-25	Ondansetron	25 in 1 CARTON	INJECTION	25		20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0641-6080	ONDANSETRON INJECTION [HIKMA PHARMACEUTICALS USA INC.]	19	Current NDC, Legacy NDC, 2 package rows	20250327_97713356-f42b-4a67-95f6-561afa68c0c2.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0641-6080-01	ML - Milliliter	0641-6080	3ecda475-6cd1-4288-a0ec-a84a0d8d4fff	1	2012-07-24
0641-6080-25	ML - Milliliter	0641-6080	5d18bfb7-bded-4583-a5b2-da3b0433d322	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 [CARDINAL HEALTH]	188557104
ONDANSETRON	ACTIVE MOIETY	4AF302ESOS	ONDANSETRON INJECTION [CARDINAL HEALTH]	188557104
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	ONDANSETRON INJECTION [CARDINAL HEALTH]	188557104
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	ONDANSETRON INJECTION [CARDINAL HEALTH]	188557104
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	ONDANSETRON INJECTION [CARDINAL HEALTH]	188557104
WATER	INACTIVE INGREDIENT	059QF0KO0R	ONDANSETRON INJECTION [CARDINAL HEALTH]	188557104
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
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

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 43 of 62 · 1,235 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Eyesaline Emergency Eyewash	PURIFIED WATER	Honeywell Safety Products USA, Inc.	ad42a7e3-84ea-390d-e053-2a95a90a3a32	2024-06-14	Warnings	Exact identifier unii: 059QF0KO0R
Derma Pain Plus	CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOXICODENDRON, SARSAPARILLA (SMILAX REGELII)	Peaceful Mountain, Inc.	6fa79c31-e48e-4c83-baa2-96cef22cfee1	2024-06-13	Warnings	Exact identifier unii: 451W47IQ8X
Cold Sore Rescue	BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA	Peaceful Mountain, Inc.	a7fe6ec7-a758-43cf-b46f-c327e0632fb8	2024-06-13	Warnings	Exact identifier unii: 451W47IQ8X
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	7f315229-7e8f-67fd-e053-2a91aa0a8cb6	2024-06-12	Warnings, Adverse reactions	Exact identifier unii: NMH84OZK2B
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	NuCare Pharmceuticals,Inc.	67395789-0ac7-2244-e053-2a91aa0a652a	2024-06-07	Warnings, Adverse reactions	Exact identifier unii: NMH84OZK2B
Eyes Alive Eye Wash	WATER	RIVIERA PHARMA INC	081079f4-1c06-4054-b771-00fedaa666f6	2024-06-05	Warnings	Exact identifier unii: 059QF0KO0R
NATRUM MUR	NATRUM MUR	Rxhomeo Private Limited d.b.a. Rxhomeo, Inc	1a22655a-68f3-4f13-e063-6294a90ae52c	2024-06-05	Warnings	Exact identifier unii: 451W47IQ8X
Sodium Citrate and Citric Acid	SODIUM CITRATE AND CITRIC ACID	Chartwell RX, LLC	525136c9-7758-437b-b57b-94b905786825	2024-05-31	Adverse reactions	Exact identifier unii: 2968PHW8QP
Sterile Water	WATER	Becton Dickinson and Company	6e43c5a3-dad2-49ed-b500-964cb4563cc9	2024-05-31	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Mentox HP	AURUM METALLICUM, BARYTA CARBONICA, CALCAREA CARBONICA, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS	Energique, Inc.	ebb23637-4931-4563-ab30-99bea0276580	2024-05-28	Warnings	Exact identifier unii: 451W47IQ8X
Potassium Chloride in Lactated Ringers and Dextrose	POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM LACTATE, AND DEXTROSE MONOHYDRATE	Fresenius Kabi USA, LLC	dbed53b7-0109-4561-8342-0178ec8c64b0	2024-05-22	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Lactated Ringers and Dextrose	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, AND DEXTROSE MONOHYDRATE	Fresenius Kabi USA, LLC	1b912c7e-f005-4af4-b683-083440964249	2024-05-22	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Sodium chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	239a5af1-7498-480f-862c-ab7c3d89d183	2024-05-21	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Sodium chloride	SODIUM CHLORIDE	Becton Dickinson and Company	ebc8b008-a8b3-4c41-89e4-b413f7aab89f	2024-05-21	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Allergies	APIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUM	Newton Laboratories, Inc.	9d5dea47-5103-21a3-e053-2995a90aee78	2024-05-20	Warnings	Exact identifier unii: 451W47IQ8X
Colopar	COLON (SUIS), ARSENICUM ALBUM, CAUSTICUM, IGNATIA AMARA, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, SEPIA, SILICEA, THUJA OCCIDENTALIS	Energique, Inc.	c47d7203-abcd-4ae5-bf9b-5df07e07d3c1	2024-05-20	Warnings	Exact identifier unii: 451W47IQ8X
Aging Eye Formula	CINERARIA MARITIMA, EYE (SUIS), CALCAREA FLUORICA, CAUSTICUM, GERMANIUM METALLICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUM, NATRUM MURIATICUM	Nutritional Specialties, Inc.	4510fe59-cc28-4585-925f-42508a60abd0	2024-05-13	Warnings	Exact identifier unii: 451W47IQ8X
Sodium Chloride	SODIUM CHLORIDE	B. Braun Medical Inc.	47a0313f-36df-4fa6-a828-c9e1946ba9b0	2024-05-08	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Potassium Chloride in Dextrose and Sodium Chloride	DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDE	Fresenius Kabi USA, LLC	f0cc6713-4d47-49be-8116-901c99002b6b	2024-05-07	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Sodium Chloride	SODIUM CHLORIDE	B. Braun Medical Inc.	7f22c06b-6b4d-4b49-a4b2-d2169f2bd653	2024-05-07	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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