NDC 58198-7425-1 - Denagard

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
58198-7425
Requested NDC
58198-7425-1
Package NDCs from labels
58198-7425-1, 58198-7425-2
Manufacturer
Elanco US Inc.
Effective date
2025-08-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Denagard™ 12.5% (tiamulin hydrogen fumarate)Elanco US Inc.2025-08-07OTC ANIMAL DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58198-7425-1Denagard1000 mL in 1 BOTTLECONCENTRATE10004
58198-7425-2Denagard5000 mL in 1 BOTTLE, PLASTICCONCENTRATE50004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58198-7425DENAGARD (TIAMULIN FUMARATE) CONCENTRATE [ELANCO US INC.]32 package rows20241027_c968bfc7-3d69-4d3b-8b5d-4c41b880daf2.zip

Reported adverse events (FAERS/openFDA)#

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