NDC 58768-358 - Fluor-Op

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
58768-358
Package NDCs from labels
58768-358-05, 58768-358-10, 58768-358-15
Manufacturer
Novartis Ophthalmics
Effective date
2006-05-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Fluor-Op - Novartis OphthalmicsNovartis Ophthalmics2006-05-11HUMAN PRESCRIPTION DRUG LABELING

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FluorometholoneACTIVE INGREDIENTSV0CSG527LFLUOR-OP (FLUOROMETHOLONE) SUSPENSION [NOVARTIS OPHTHALMICS]1
FluorometholoneACTIVE MOIETYSV0CSG527LFLUOR-OP (FLUOROMETHOLONE) SUSPENSION [NOVARTIS OPHTHALMICS]1
benzalkonium chlorideINACTIVE INGREDIENTFLUOR-OP (FLUOROMETHOLONE) SUSPENSION [NOVARTIS OPHTHALMICS]1
edetate disodiumINACTIVE INGREDIENT7FLD91C86KFLUOR-OP (FLUOROMETHOLONE) SUSPENSION [NOVARTIS OPHTHALMICS]1
polysorbate 80INACTIVE INGREDIENTFLUOR-OP (FLUOROMETHOLONE) SUSPENSION [NOVARTIS OPHTHALMICS]1
polyvinyl alcoholINACTIVE INGREDIENTFLUOR-OP (FLUOROMETHOLONE) SUSPENSION [NOVARTIS OPHTHALMICS]1
sodium chlorideINACTIVE INGREDIENT451W47IQ8XFLUOR-OP (FLUOROMETHOLONE) SUSPENSION [NOVARTIS OPHTHALMICS]1
sodium hydroxideINACTIVE INGREDIENT55X04QC32IFLUOR-OP (FLUOROMETHOLONE) SUSPENSION [NOVARTIS OPHTHALMICS]1
sodium phosphate dibasic, anhydrousINACTIVE INGREDIENTFLUOR-OP (FLUOROMETHOLONE) SUSPENSION [NOVARTIS OPHTHALMICS]1
sodium phosphate monobasic, monohydrateINACTIVE INGREDIENTFLUOR-OP (FLUOROMETHOLONE) SUSPENSION [NOVARTIS OPHTHALMICS]1
waterINACTIVE INGREDIENT059QF0KO0RFLUOR-OP (FLUOROMETHOLONE) SUSPENSION [NOVARTIS OPHTHALMICS]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
545776FE-63DF-44AB-ACE3-F3D73D2E0092545776FE-63DF-44AB-ACE3-F3D73D2E00922006-05-11Warnings, Adverse reactionsExact identifier
spl id: 545776FE-63DF-44AB-ACE3-F3D73D2E0092
spl set id: 545776FE-63DF-44AB-ACE3-F3D73D2E0092

Reported adverse events (FAERS/openFDA)#

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