NDC 0049-3900-28 - Trovan

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
0049-3900
Requested NDC
0049-3900-28
Package NDCs from labels
0049-3900-28
Manufacturer
Roerig
Effective date
2006-02-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Trovan - RoerigRoerig2006-02-06HUMAN PRESCRIPTION DRUG LABELING

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
trovafloxacin mesylateACTIVE INGREDIENT0P1LKO80WNTROVAN (TROVAFLOXACIN MESYLATE) TABLET, FILM COATED TROVAN (TROVAFLOXACIN MESYLATE) INJECTION, SOLUTION, CONCENTRATE [ROERIG]1
trovafloxacinACTIVE MOIETY9F388J00UKTROVAN (TROVAFLOXACIN MESYLATE) TABLET, FILM COATED TROVAN (TROVAFLOXACIN MESYLATE) INJECTION, SOLUTION, CONCENTRATE [ROERIG]1
cross linked sodium carboxymethylcelluloseINACTIVE INGREDIENTTROVAN (TROVAFLOXACIN MESYLATE) TABLET, FILM COATED TROVAN (TROVAFLOXACIN MESYLATE) INJECTION, SOLUTION, CONCENTRATE [ROERIG]1
FD&C blue #2 aluminum lakeINACTIVE INGREDIENTTROVAN (TROVAFLOXACIN MESYLATE) TABLET, FILM COATED TROVAN (TROVAFLOXACIN MESYLATE) INJECTION, SOLUTION, CONCENTRATE [ROERIG]1
hydrochloric acidINACTIVE INGREDIENTQTT17582CBTROVAN (TROVAFLOXACIN MESYLATE) TABLET, FILM COATED TROVAN (TROVAFLOXACIN MESYLATE) INJECTION, SOLUTION, CONCENTRATE [ROERIG]1
hydroxypropylcelluloseINACTIVE INGREDIENTTROVAN (TROVAFLOXACIN MESYLATE) TABLET, FILM COATED TROVAN (TROVAFLOXACIN MESYLATE) INJECTION, SOLUTION, CONCENTRATE [ROERIG]1
hydroxypropylmethylcelluloseINACTIVE INGREDIENTTROVAN (TROVAFLOXACIN MESYLATE) TABLET, FILM COATED TROVAN (TROVAFLOXACIN MESYLATE) INJECTION, SOLUTION, CONCENTRATE [ROERIG]1
magnesium stearateINACTIVE INGREDIENT70097M6I30TROVAN (TROVAFLOXACIN MESYLATE) TABLET, FILM COATED TROVAN (TROVAFLOXACIN MESYLATE) INJECTION, SOLUTION, CONCENTRATE [ROERIG]1
microcrystalline celluloseINACTIVE INGREDIENTTROVAN (TROVAFLOXACIN MESYLATE) TABLET, FILM COATED TROVAN (TROVAFLOXACIN MESYLATE) INJECTION, SOLUTION, CONCENTRATE [ROERIG]1
polyethylene glycolINACTIVE INGREDIENTTROVAN (TROVAFLOXACIN MESYLATE) TABLET, FILM COATED TROVAN (TROVAFLOXACIN MESYLATE) INJECTION, SOLUTION, CONCENTRATE [ROERIG]1
sodium hydroxideINACTIVE INGREDIENT55X04QC32ITROVAN (TROVAFLOXACIN MESYLATE) TABLET, FILM COATED TROVAN (TROVAFLOXACIN MESYLATE) INJECTION, SOLUTION, CONCENTRATE [ROERIG]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPTROVAN (TROVAFLOXACIN MESYLATE) TABLET, FILM COATED TROVAN (TROVAFLOXACIN MESYLATE) INJECTION, SOLUTION, CONCENTRATE [ROERIG]1
WaterINACTIVE INGREDIENTTROVAN (TROVAFLOXACIN MESYLATE) TABLET, FILM COATED TROVAN (TROVAFLOXACIN MESYLATE) INJECTION, SOLUTION, CONCENTRATE [ROERIG]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
DFF1F954-C69D-672C-0802-8559DB322C6FDA9B26BB-D2D7-4113-A0F9-C6C2280F48752006-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: DFF1F954-C69D-672C-0802-8559DB322C6F
spl set id: DA9B26BB-D2D7-4113-A0F9-C6C2280F4875

Reported adverse events (FAERS/openFDA)#

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