NDC 67286-0054 - Busulfex

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
67286-0054
Package NDCs from labels
67286-0054-2
Manufacturer
ESP Pharma, Inc.
Effective date
2007-05-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
IV Busulfex (busulfan) InjectionESP Pharma, Inc.2007-05-14Human Prescription Drug Label

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BusulfanACTIVE INGREDIENTG1LN9045DKBUSULFEX (BUSULFAN) INJECTION [ESP PHARMA, INC.]1
BusulfanACTIVE MOIETYG1LN9045DKBUSULFEX (BUSULFAN) INJECTION [ESP PHARMA, INC.]1
N,N-dimethylacetamide (DMA)INACTIVE INGREDIENTBUSULFEX (BUSULFAN) INJECTION [ESP PHARMA, INC.]1
Polyethylene Glycol 400INACTIVE INGREDIENTBUSULFEX (BUSULFAN) INJECTION [ESP PHARMA, INC.]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 1 of 1 ยท 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
335B84B4-FF21-B9AE-F17B-F0C5D4DEE70603dc50f9-c7bd-4c0c-8bbb-c1216ec90c952007-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: 335B84B4-FF21-B9AE-F17B-F0C5D4DEE706
spl set id: 03dc50f9-c7bd-4c0c-8bbb-c1216ec90c95

Reported adverse events (FAERS/openFDA)#

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