FDA.reportPublic FDA data

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
LabelManufacturerEffective dateType
Ondansetron - Hikma Pharmaceuticals USA Inc.Hikma Pharmaceuticals USA Inc.2026-04-16HUMAN PRESCRIPTION DRUG LABEL
Ondansetron - Cardinal Health 107, LLCCardinal Health 107, LLC2025-06-20HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0641-6080-01Ondansetron2 mL in 1 VIALINJECTION220
0641-6080-25Ondansetron25 in 1 CARTONINJECTION2520

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6080ONDANSETRON INJECTION [HIKMA PHARMACEUTICALS USA INC.]19Current NDC, Legacy NDC, 2 package rows20250327_97713356-f42b-4a67-95f6-561afa68c0c2.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6080-01ML - Milliliter0641-60803ecda475-6cd1-4288-a0ec-a84a0d8d4fff12012-07-24
0641-6080-25ML - Milliliter0641-60805d18bfb7-bded-4583-a5b2-da3b0433d32212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ONDANSETRON HYDROCHLORIDEACTIVE INGREDIENTNMH84OZK2BONDANSETRON INJECTION [CARDINAL HEALTH]188557104
ONDANSETRONACTIVE MOIETY4AF302ESOSONDANSETRON INJECTION [CARDINAL HEALTH]188557104
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPONDANSETRON INJECTION [CARDINAL HEALTH]188557104
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XONDANSETRON INJECTION [CARDINAL HEALTH]188557104
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KONDANSETRON INJECTION [CARDINAL HEALTH]188557104
WATERINACTIVE INGREDIENT059QF0KO0RONDANSETRON INJECTION [CARDINAL HEALTH]188557104
ONDANSETRON HYDROCHLORIDEACTIVE INGREDIENTNMH84OZK2BONDANSETRON INJECTION [WEST-WARD PHARMACEUTICAL CORP.]11
ONDANSETRONACTIVE MOIETY4AF302ESOSONDANSETRON INJECTION [WEST-WARD PHARMACEUTICAL CORP.]11
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPONDANSETRON INJECTION [WEST-WARD PHARMACEUTICAL CORP.]11
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XONDANSETRON INJECTION [WEST-WARD PHARMACEUTICAL CORP.]11
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KONDANSETRON INJECTION [WEST-WARD PHARMACEUTICAL CORP.]11
WATERINACTIVE INGREDIENT059QF0KO0RONDANSETRON 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 48 of 62 · 1,235 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Natrum muriaticumSODIUM CHLORIDEBoiron8646d7ea-cf5e-607d-e053-2a91aa0aeca12023-11-14Exact identifier
unii: 451W47IQ8X
Natrum muriaticumSODIUM CHLORIDEBoiron86466121-7217-d053-e053-2a91aa0a8f8a2023-11-14Exact identifier
unii: 451W47IQ8X
Natrum muriaticumSODIUM CHLORIDEBoiron864669c9-5bdc-232f-e053-2a91aa0a1fc62023-11-14Exact identifier
unii: 451W47IQ8X
Natrum muriaticumSODIUM CHLORIDEBoiron86462e06-d221-36b7-e053-2991aa0a1d822023-11-14Exact identifier
unii: 451W47IQ8X
OndansetronONDANSETRON HYDROCHLORIDEFresenius Kabi USA, LLCe0050959-c14c-41b6-9a92-fadc5f6feff32023-11-02Warnings, Adverse reactionsExact identifier
rxcui: 283504
rxcui: 1740467
unii: NMH84OZK2B
Mineffect nasal mistCALCAREA SILICATA, SILICEA, SULPHUR, NATRUM MURIATICUM, FERRUM METALLICUM, FERRUM PHOSPHORICUM, PHOSPHORUS, FERRUM MURIATICUM, TITANIUM METALLICUM,Kadesh Incoporation Co,Ltd3a29bf95-a8a3-4517-aedf-0cd4a91b349c2023-10-31WarningsExact identifier
unii: 451W47IQ8X
InsomniaAQUILEGIA VULGARIS, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HUMULUS LUPULUS, HYPERICUM PERFORATUM, KALI PHOSPHORICUM, MELATONIN, MELISSA OFFICINALIS, NATRUM MURIATICUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALISLiddell Laboratories, Inc.18c15f17-1a16-4595-9d23-20353363cd722023-10-31WarningsExact identifier
unii: 451W47IQ8X
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEA-S Medication Solutions674ea285-8f84-4603-9655-82200c523fe52023-10-25Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
SalineNASALGERI-CARE PHARMACEUTICAL CORPd293cc13-4043-0d58-e053-2995a90a3fbc2023-10-24WarningsExact identifier
unii: 451W47IQ8X
Natrum muriaticumSODIUM CHLORIDEBoiron8644ffef-f0ec-5c06-e053-2a91aa0ae83d2023-10-23Exact identifier
unii: 451W47IQ8X
Aqua marinaSODIUM CHLORIDEBoiron6a212a52-32be-21b8-e053-2991aa0aea2f2023-10-22Exact identifier
unii: 451W47IQ8X
MetabCALCAREA SULPHURICA, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, CEREBELLUM (SUIS), GALLBLADDER (BOVINE), HEART (BOVINE), HEPAR (BOVINE), HYPOTHALAMUS SUIS, INTESTINE (SUIS), KIDNEY (BOVINE), LUNG (BOVINE), MEDULLA OSSIS SUIS, PANCREAS SUIS, PINEAL GLAND (SUIS), RECTAL MUCOSA (SUIS), SPLEEN (BOVINE), STOMACH (SUIS), THYMUS (OVINE), THYROIDINUM (BOVINE), URINARY BLADDER (SUIS), PITUITARUM POSTERIUM (BOVINE), ACETYL COENZYME A,Nutritional Specialties, Inc.bbed9973-238f-47c5-9a50-ac0869a7eb3a2023-10-09WarningsExact identifier
unii: 451W47IQ8X
Isolyte S pH 7.4SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM PHOSPHATE, DIBASIC, AND POTASSIUM PHOSPHATEB. Braun Medical Inc.150437b6-320e-4c69-a434-2a26a1f0b2e42023-10-06Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
ONDANSETRONONDANSETRONChartwell RX, LLC88b7432b-f5a7-40f3-9b0c-e7b125f5103c2023-10-05Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
PhysiolyteSODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDEB. Braun Medical Inc.19c04dcb-d6f2-4624-afd4-1c7b7ddcb85e2023-09-26Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
AllergiesAPIS 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, CINNAMOMUMNewton Laboratories, Inc.0631d5e5-9da4-bcb7-e063-6394a90a62de2023-09-25WarningsExact identifier
unii: 451W47IQ8X
Epiforce P-HPARSENICUM ALBUM, BORAX, GRAPHITES, NATRUM MURIATICUM, SEPIA, SULPHURBioActive Nutritional, Inc.250441d1-e261-417e-9100-700368ea38fd2023-09-11WarningsExact identifier
unii: 451W47IQ8X
Lactated RingersSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEB. Braun Medical Inc.a9910e09-5aea-4ee1-a35e-ae4abf8b80b42023-09-07Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
ANUBISMEDHA HYALURONICANUBIS COSMETICS SLeac771e2-4c1b-3808-e053-2995a90ac5fc2023-09-05WarningsExact identifier
unii: 059QF0KO0R
AnubisMedSPF 50 BROAD SPECTRUM PROTECTION FLUID EMULSIONANUBIS COSMETICS SLe99d92c4-8768-9c0a-e053-2a95a90a609e2023-09-05WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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