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 31 of 62 · 1,235 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bestmade Natural Products BIO4CALC FLUOR, KALI MUR, NAT MUR, SILICEABestmade Natural Products2ffcffd8-94ba-3a4c-e063-6394a90a24ee2025-03-10WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO5FERR PHOS, KALI MUR, NAT MUR, KALI SULPHBestmade Natural Products2ffd4d8f-75bf-1b9b-e063-6294a90abc362025-03-10WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO6FERR PHOS, KALI MUR, MAG PHOS, NAT MUR, NAT SULPHBestmade Natural Products2ffd93dd-1084-4b24-e063-6294a90a14332025-03-10WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO11FERR PHOS, KALI MUR, KALI SULPH, NAT MUR, NAT SULPHBestmade Natural Products2fff2361-a171-2249-e063-6394a90a8b652025-03-10WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO12FERR PHOS, NAT MUR, KALI PHOS, MAG PHOSBestmade Natural Products2fff612e-16dc-dcbf-e063-6294a90a22ad2025-03-10WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO16CALC PHOS, FERR PHOS, KALI PHOS, MAG PHOS, NAT MURBestmade Natural Products30002ebe-3b38-cb35-e063-6394a90a8f7e2025-03-10WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO1CALC PHOS FERR PHOS, KALI PHOS, NAT MURBestmade Natural Products2fd724b6-c6cf-652a-e063-6294a90ab4d72025-03-08WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO2KALI PHOS, MAG PHOS, NAT MUR, NAT SULPHBestmade Natural Products2fd794c0-a553-e3f5-e063-6294a90a522a2025-03-08WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products Field of Flowers FormulaAESCULUS CAR, AESCULUS HIP, AGRIMONIA EUP, BROMUS RAM, CALLUNA VULG, CARPINUS BET, CASTANEA SAT, CENTAURIUM UMB, CERATOSTIGMA WILLM, CICHORIUM INT, CLEMATIS VIT, FAGUS SYLV, GENTIANELLA AMARELLA, HELIANTHEMUM NUMMULARIUM, ILEX AQUIFOLIUM, IMPATIENS GLAND, LARIX DECIDUA, LONICERA CAPRIFOLIUM, MALUS, MIMULUS GUT, OLEA EUROP, ORNITHOGALUM UMB, PINUS SYL, POPULUS TREM, PRUNUS CERA, QUERCUS ROB, ROCK WATER, ROSA CAN, SALIX VIT, SCLERANTHUS ANNNUS, SINAPIS ARV, ULEX EURO, ULMUS PROC, VERBENA, VITIS VINBestmade Natural Products2fbf9b7c-e54f-589d-e063-6394a90a14a72025-03-07WarningsExact identifier
unii: 059QF0KO0R
Bestmade Natural Products BM253CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, MAG PHOS, NAT MURBestmade Natural Products2fa9913f-0593-f77b-e063-6394a90ab6b22025-03-06WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BM254APIS MEL, BRYONIA, GELSEMIUM, NAT MUR, PULSATILLABestmade Natural Products2fa9bb2c-848b-06ef-e063-6394a90ad0f02025-03-06WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products Nat MurNATRUM MURIATICUMBestmade Natural Products2fa9f3a3-91e3-2f8e-e063-6294a90afda82025-03-06WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BM244CALC CARB, CALC PHOS, CARBO VEG, NAT MUR, PHYSOSTIGMA, RUTA GRAV.Bestmade Natural Products2f853410-e831-90ce-e063-6394a90a26b12025-03-04WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BM214CARBO VEG, FERRUM PHOS, SILICA, KALI CARB, CALC PHOS, NAT MURBestmade Natural Products2f6e08d8-a6f9-c049-e063-6394a90a6df12025-03-03WarningsExact identifier
unii: 451W47IQ8X
AeroWash EyewashEYEWASH SOLUTIONAero Healthcare US LLCa477de08-4301-0ee5-e053-2995a90af79d2025-02-26WarningsExact identifier
unii: 059QF0KO0R
Adrenal LiquescenceGLYCYRRHIZA GLABRA, ROSA CANINA, ARALIA QUINQUEFOLIA, GLANDULA SUPRARENALIS (BOVINE), ADRENALINUM, CINCHONA OFFICINALIS, NATRUM MURIATICUM, ZINCUM METALLICUM, ADRENOCORTICOTROPHINNutritional Specialties, Inc.5254181b-188e-4ef2-b91e-15e87e31de702025-02-26WarningsExact identifier
unii: 451W47IQ8X
OndansetronONDANSETRONNuCare Pharmaceuticals, Inc.2eeb3c61-4ce9-d8ed-e063-6294a90a00d32025-02-24Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
Bestmade Natural Products BM188ALLIUM CEPA, AMBROSIA ARTEMISIA, GELSEMIUM, KALI BICHROME, NAT MUR, SABADILLABestmade Natural Products2e950192-e5cf-37b4-e063-6394a90a1e9a2025-02-20WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BM168CONIUM, PILOCARPINE MURIATE, KALI SIL, KALI ARS, SULPHUR, NAT MURBestmade Natural Products2e7bc230-8a37-9975-e063-6294a90a15e72025-02-19WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BM173ECHINACEA, EUPHRASIA, NATRUM MUR, RHUS TOX, SILICEA, SULPHUR, URTICA URENBestmade Natural Products2e7de086-a4c1-ae9e-e063-6394a90aa5f52025-02-19WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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