FDA.reportPublic FDA data

NDC 0004-0264-49 - Demadex

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
0004-0264
Requested NDC
0004-0264-49
Package NDCs from labels
0004-0264-01, 0004-0264-49
Manufacturer
Roche Pharmaceuticals
Effective date
2007-02-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Demadex - Roche PharmaceuticalsRoche Pharmaceuticals2007-02-06HUMAN PRESCRIPTION DRUG LABELING

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
torsemideACTIVE INGREDIENTW31X2H97FBDEMADEX (TORSEMIDE) TABLET DEMADEX (TORSEMIDE) INJECTION, SOLUTION [ROCHE PHARMACEUTICALS]1
torsemideACTIVE MOIETYW31X2H97FBDEMADEX (TORSEMIDE) TABLET DEMADEX (TORSEMIDE) INJECTION, SOLUTION [ROCHE PHARMACEUTICALS]1
crospovidoneINACTIVE INGREDIENTDEMADEX (TORSEMIDE) TABLET DEMADEX (TORSEMIDE) INJECTION, SOLUTION [ROCHE PHARMACEUTICALS]1
lactoseINACTIVE INGREDIENTDEMADEX (TORSEMIDE) TABLET DEMADEX (TORSEMIDE) INJECTION, SOLUTION [ROCHE PHARMACEUTICALS]1
magnesium stearateINACTIVE INGREDIENT70097M6I30DEMADEX (TORSEMIDE) TABLET DEMADEX (TORSEMIDE) INJECTION, SOLUTION [ROCHE PHARMACEUTICALS]1
microcrystalline celluloseINACTIVE INGREDIENTDEMADEX (TORSEMIDE) TABLET DEMADEX (TORSEMIDE) INJECTION, SOLUTION [ROCHE PHARMACEUTICALS]1
polyethylene glycol-400INACTIVE INGREDIENTDEMADEX (TORSEMIDE) TABLET DEMADEX (TORSEMIDE) INJECTION, SOLUTION [ROCHE PHARMACEUTICALS]1
povidoneINACTIVE INGREDIENTDEMADEX (TORSEMIDE) TABLET DEMADEX (TORSEMIDE) INJECTION, SOLUTION [ROCHE PHARMACEUTICALS]1
sodium hydroxideINACTIVE INGREDIENT55X04QC32IDEMADEX (TORSEMIDE) TABLET DEMADEX (TORSEMIDE) INJECTION, SOLUTION [ROCHE PHARMACEUTICALS]1
tromethamineINACTIVE INGREDIENT023C2WHX2VDEMADEX (TORSEMIDE) TABLET DEMADEX (TORSEMIDE) INJECTION, SOLUTION [ROCHE PHARMACEUTICALS]1
waterINACTIVE INGREDIENT059QF0KO0RDEMADEX (TORSEMIDE) TABLET DEMADEX (TORSEMIDE) INJECTION, SOLUTION [ROCHE PHARMACEUTICALS]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
CF288AD5-D4E7-4B0B-BFD0-41C5327E6984CF288AD5-D4E7-4B0B-BFD0-41C5327E69842007-02-06Warnings, Adverse reactionsExact identifier
spl id: CF288AD5-D4E7-4B0B-BFD0-41C5327E6984
spl set id: CF288AD5-D4E7-4B0B-BFD0-41C5327E6984

Reported adverse events (FAERS/openFDA)#

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