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 40 of 60 · 1,189 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Empathy	AETHUSA CYNAPIUM, AMBRA GRISEA, ARGEMONE MEXICANA, CANDIDA ALBICANS, CARLSBAD AQUA, CEREBRUM SUIS, COCCULUS INDICUS, COFFEA TOSTA, CROCUS SATIVUS, CYCLAMEN EUROPAEUM, MAGNESIA CARBONICA, NATRUM CARBONICUM, NUPHAR LUTEUM, NUX MOSCHATA, PHOSPHORUS, PLACENTA TOTALIS SUIS, ROSA DAMASCENA, SUCCINUM, VIOLA ODORATA	Deseret Biologicals, Inc.	a89067c1-ef12-49da-8fa6-e65ff664f497	2024-08-13	Warnings	Exact identifier unii: 059QF0KO0R
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Bryant Ranch Prepack	115e8fb5-61f5-4719-8eb3-063b7ca194ae	2024-08-08	Warnings, Adverse reactions	Exact identifier unii: NMH84OZK2B
Lymph/Spleen Combo	ADENOSINUM TRIPHOSPHORICUM DINATRUM, APIS MELLIFICA, CASTANEA VESCA, CEANOTHUS AMERICANUS, CHININUM ARSENICOSUM, FERRUM METALLICUM, HELIANTHUS ANNUUS, JUNIPERUS COMMUNIS, LYMPH NODE (SUIS), MYOSOTIS ARVENSIS, NATRUM MURIATICUM, NATRUM SULPHURICUM, PHYTOLACCA DECANDRA, QUERCUS GLANDIUM SPIRITUS, SPLEEN (SUIS), SUCCINUM, THYMUS (SUIS), UBIDECARENONUM	Deseret Biologicals, Inc.	afce86e2-cbfa-44d4-b803-bc2ad5053357	2024-07-31	Warnings	Exact identifier unii: 451W47IQ8X
Lymph/Spleen Combo	JUNIPERUS COMMUNIS, QUERCUS GLANDIUM SPIRITUS, MYOSOTIS ARVENSIS, NATRUM SULPHURICUM, CEANOTHUS AMERICANUS, HELIANTHUS ANNUUS, NATRUM MURIATICUM, PHYTOLACCA DECANDRA, LYMPH NODE (SUIS), SPLEEN (SUIS), THYMUS (SUIS), CHININUM ARSENICOSUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, UBIDECARENONUM, FERRUM METALLICUM, SUCCINUM, CASTANEA VESCA, APIS MELLIFICA	Deseret Biologicals, Inc.	b55787b5-5e35-4342-8f00-ef202c353877	2024-07-31	Warnings	Exact identifier unii: 451W47IQ8X
Adrenapar	ARALIA QUINQUEFOLIA, AVENA SATIVA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS SUIS, ARSENICUM IODATUM, CALCAREA CARBONICA, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ZINCUM METALLICUM	Energique, Inc.	4080fcfb-7ef2-45f5-8c3b-592d3b66a120	2024-07-29	Warnings	Exact identifier unii: 451W47IQ8X
Sodium Chloride	SODIUM CHLORIDE	Baxter Healthcare Corporation	f55bd888-5e01-474d-871b-24654c070178	2024-07-24	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Sodium chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	83994d0c-8484-4505-abb5-8a384ed12288	2024-07-22	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Bryant Ranch Prepack	d6694136-7591-4f23-8415-f2aa3c8bab40	2024-07-16	Warnings, Adverse reactions	Exact identifier unii: NMH84OZK2B
sodium chloride	SODIUM CHLORIDE	Becton Dickinson and Company	8df7dcf6-8714-6caf-e053-2995a90ab8cc	2024-07-15	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Thompson Safety Eyewash	WATER	Thompson Safety	1d0e96cf-245b-cfb7-e063-6294a90a4ced	2024-07-12	Warnings	Exact identifier unii: 059QF0KO0R
ONDANSETRON	ONDANSETRON	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	8cea2f3a-cfa5-4a68-9ff4-b5a5a2085d08	2024-06-25	Warnings, Adverse reactions	Exact identifier rxcui: 283504 rxcui: 1740467 unii: NMH84OZK2B
Ondansetron	ONDANSETRON HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	1b406d22-f1bf-460d-e063-6294a90a6b6f	2024-06-19	Warnings, Adverse reactions	Exact identifier unii: NMH84OZK2B
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	91bfbc0e-86a3-8ac6-e053-2a95a90af432	2024-06-19	Warnings, Adverse reactions	Exact identifier unii: NMH84OZK2B
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	NUCARE PHARMACEUTICALS INC	8d696b8c-eba6-505e-e053-2995a90acb5d	2024-06-18	Warnings, Adverse reactions	Exact identifier unii: NMH84OZK2B
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

Reported adverse events (FAERS/openFDA)#

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