FDA.reportPublic FDA data

NDC 58063-797 - ALOXI

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
58063-797
Package NDCs from labels
58063-797-25, 58063-797-99, 58063-797-37
Manufacturer
MGI PHARMA
Effective date
2008-09-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ALOXI - MGI PHARMAMGI PHARMA2008-09-23HUMAN PRESCRIPTION DRUG LABEL WITH HIGHLIGHTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58063-797-25ALOXI5 mL in 1 VIALINJECTION53
58063-797-37ALOXI5 in 1 CARTONINJECTION53
58063-797-99ALOXI1.5 mL in 1 VIALINJECTION1.53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58063-797ALOXI (PALONOSETRON HYDROCHLORIDE) INJECTION [MGI PHARMA]33 package rows20090108_F4216772-6C37-4FF0-A575-F758390656E3.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
palonosetron hydrochlorideACTIVE INGREDIENT23310D4I19ALOXI (PALONOSETRON HYDROCHLORIDE) INJECTION [MGI PHARMA]3
palonosetronACTIVE MOIETY5D06587D6RALOXI (PALONOSETRON HYDROCHLORIDE) INJECTION [MGI PHARMA]3
citrate bufferINACTIVE INGREDIENTALOXI (PALONOSETRON HYDROCHLORIDE) INJECTION [MGI PHARMA]3
disodium edetateINACTIVE INGREDIENT7FLD91C86KALOXI (PALONOSETRON HYDROCHLORIDE) INJECTION [MGI PHARMA]3
mannitolINACTIVE INGREDIENT3OWL53L36AALOXI (PALONOSETRON HYDROCHLORIDE) INJECTION [MGI PHARMA]3
waterINACTIVE INGREDIENT059QF0KO0RALOXI (PALONOSETRON HYDROCHLORIDE) INJECTION [MGI PHARMA]3

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 1 of 1 ยท 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PalonosetronPALONOSETRONBluePoint Laboratoriesee6f6f94-1ca7-481e-9909-b19ae64e80c22026-08-25Warnings, Adverse reactionsExact identifier
rxcui: 1728055
PalonosetronPALONOSETRON HYDROCHLORIDEBLuePoint Laboratoriesbb2be46a-56f7-48b6-bb05-3c6b12c8b1ea2026-07-06Warnings, Adverse reactionsExact identifier
rxcui: 1728055
PalonosetronPALONOSETRONNorthStar Rx LLC689c953c-2120-2546-67a4-22bb34ba33302025-12-24Warnings, Adverse reactionsExact identifier
rxcui: 1728055
Palonosetron HydrochloridePALONOSETRON HYDROCHLORIDEEugia US LLC42e2d437-0712-4e9c-9c2a-00093c406d622025-10-30Warnings, Adverse reactionsExact identifier
rxcui: 1728055
PalonosetronPALONOSETRON HYDROCHLORIDEApotex Corp.4af600d1-0ab1-41c5-af2f-9dc24cf3c90e2025-06-09Warnings, Adverse reactionsExact identifier
rxcui: 1728055
posfreaPALONOSETRONAvyxa Pharma, LLC13a201ba-c86d-48c5-a0e1-a3e0b4e6a2a72025-04-29Warnings, Adverse reactionsExact identifier
rxcui: 1728055
rxcui: 1728050
PalonosetronPALONOSETRON HYDROCHLORIDEApotex Corp.903d7aba-277e-6d28-4fee-fd2d605ab6a92025-01-02Warnings, Adverse reactionsExact identifier
rxcui: 1728055
Palonosetron HydrochloridePALONOSETRON HYDROCHLORIDESandoz Incaff1505c-8d34-46e6-9559-c5b1128878752024-02-05Warnings, Adverse reactionsExact identifier
rxcui: 1728055
Palonosetron HydrochloridePALONOSETRON HYDROCHLORIDEMeitheal Pharmaceuticals Inc.11bb07b2-6530-45ab-a916-ba9dd3107fc32023-08-17Warnings, Adverse reactionsExact identifier
rxcui: 1728055
palonosetron hydrochloridePALONOSETRON HYDROCHLORIDECipla USA Inc.37e7ef89-fd77-44e0-9271-ae91f88226032022-01-13Warnings, Adverse reactionsExact identifier
rxcui: 1728055
PalonosetronPALONOSETRON HYDROCHLORIDEQilu Pharmaceutical Co., Ltd.633abdc2-a942-4eb2-a0f8-f9f4e727211e2021-10-18Warnings, Adverse reactionsExact identifier
rxcui: 1728055
rxcui: 1728050
PALONOSETRONPALONOSETRONFresenius Kabi USA, LLC9132366b-b808-46c9-b167-c1900bc116b32020-12-29Warnings, Adverse reactionsExact identifier
rxcui: 1728055
Palonosetron HydrochloridePALONOSETRON HYDROCHLORIDEBaxter Healthcare Corporation0f3bfe3d-75c8-42eb-84be-570f8e251fdd2020-09-15Warnings, Adverse reactionsExact identifier
rxcui: 1728055
PalonosetronPALONOSETRONDr.Reddy's Laboratories Limited991b8452-852c-c55c-7b1b-e97c4964777a2020-08-30Warnings, Adverse reactionsExact identifier
rxcui: 1728055
rxcui: 1728050
Palonosetron HydrochloridePALONOSETRON HYDROCHLORIDEMylan Institutional LLC0a781796-bb74-4c5f-8d26-9ce520b818f72020-06-09Warnings, Adverse reactionsExact identifier
rxcui: 1728055
palonosetron hydrochloridePALONOSETRON HYDROCHLORIDESagent Pharmaceuticals6e60d03d-eae6-4924-a507-e77ea077c1ab2020-04-28Warnings, Adverse reactionsExact identifier
rxcui: 1728055
Palonosetron HydrochloridePALONOSETRON HYDROCHLORIDETeva Parenteral Medicines, Inc.911783eb-91a8-4ef4-bd6f-809211e207d62020-04-01Warnings, Adverse reactionsExact identifier
rxcui: 1728055

Reported adverse events (FAERS/openFDA)#

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