FDA.reportPublic FDA data

NDC 65293-374-20 - 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
65293-374
Requested NDC
65293-374-20
Package NDCs from labels
65293-374-20, 65293-374-01
Manufacturer
The Medicines Company | Fresenius Kabi USA, LLC
Effective date
2019-12-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ondansetron - The Medicines Company | Fresenius Kabi USA, LLCThe Medicines Company | Fresenius Kabi USA, LLC2019-12-16HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-04-01Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65293-374-01ML - Milliliter65293-374fda21d3a-cff2-4c5e-9a7b-844e5e6d903c12013-04-01
65293-374-20ML - Milliliter65293-3746300e026-8c79-4000-8c49-c5f00241cbf812013-04-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ONDANSETRON HYDROCHLORIDEACTIVE INGREDIENTNMH84OZK2BONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION [THE MEDICINES COMPANY]1
ONDANSETRONACTIVE MOIETY4AF302ESOSONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION [THE MEDICINES COMPANY]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION [THE MEDICINES COMPANY]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION [THE MEDICINES COMPANY]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION [THE MEDICINES COMPANY]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION [THE MEDICINES COMPANY]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION [THE MEDICINES COMPANY]1

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 3 of 54 · 1,064 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hypertonic SalineSODIUM CHLORIDENAVEH PHARMA (1996) LTD167c7a9c-1228-4fb2-a89c-d3e1483863232026-07-30WarningsExact identifier
unii: 451W47IQ8X
Hypertonic Saline Solution Sodium ChlorideSODIUM CHLORIDENAVEH PHARMA (1996) LTD750ea4b1-de2b-4299-aaa2-331daf383d0d2026-07-30WarningsExact identifier
unii: 451W47IQ8X
IDkit HP ONECITRIC ACID ANHYDROUS AND 13C UREAMeridian Bioscience Israel Ltd8baab7a7-5d20-46ad-9c4a-762992ef6b512026-07-28Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
DelflexDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care de Mexico, S.A. de C.V.a98facd6-9daa-4d37-8209-63a0599dbfaa2026-07-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEFresenius Medical Care de Mexico, S.A. de C.V.9a1220fb-6853-45ae-838c-10d8596e1af72026-07-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLCaf5cdf1a-19f4-11e2-892e-0800200c9a662026-07-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDESt. Mary's Medical Park Pharmacy57b0a1e5-5dfa-64a0-e063-6394a90acf362026-07-24Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
PEG 3350 and ElectrolytesPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDEA-S Medication Solutions19daf830-7270-4661-81b1-ded38f867f282026-07-24Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
ONDANSETRONONDANSETRONHenry Schein, Inc.1a44601b-c31c-4779-a688-28cc4cc75e8b2026-07-23Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
ondansetron hydrochlorideONDANSETRON HYDROCHLORIDEIpca Laboratories Limited7ab3210e-eed1-479a-afc0-f72b5b7768832026-07-22Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
ondansetronONDANSETRON HYDROCHLORIDEAscend Laboratories, LLC2edc0788-dc38-4d21-ba8e-71f159e2d3b12026-07-22Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
Whisidom Saline SolutionSODIUM CHLORIDE 0.9% SALINE SOLUTIONJiangxi Yudexi Pharmaceutical Co., LTD4e4e4169-2a14-3466-e063-6394a90a081b2026-07-20WarningsExact identifier
unii: 451W47IQ8X
ondansetronONDANSETRON HYDROCHLORIDECardinal Health 107, LLCcb02f2d7-31a9-4f12-880e-7ce7d85440d42026-07-17Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
SalineNASALBEST CHOICE (VALU MERCHANDISERS COMPANY)71485e82-bf54-4b8b-8dd2-2a07615345202026-07-17WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDELABORATORIOS GRIFOLS SAeb811d79-fdb8-1f1a-c2ad-1cc4bfc7eadf2026-07-15Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
WHWSWB 0.9% SALINESODIUM CHLORIDEYiwu Huanshu E-commerce Co., Ltd5082b773-79b2-2501-e063-6394a90a170f2026-07-11WarningsExact identifier
unii: 451W47IQ8X
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEBryant Ranch Prepack3f2e8efe-7fd4-407c-a77b-bd6dd04608e22026-07-10Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEREMEDYREPACK INC.ee3e8cbe-4f0b-4361-a1b5-8329d85a29322026-07-08Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEUnit Dose Solutions, Inc.561dce26-92fa-e00b-e063-6294a90a1ab22026-07-08Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
SALINE NASALSODIUM CHLORIDEALAINA HEALTHCARE PRIVATE LIMITEDed30a7f9-7132-42da-9bed-63a9b1c80ab22026-07-07WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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