FDA.reportPublic FDA data

NDC 58198-9413-1 - Denagard 80 coated Type A Medicated Article

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
58198-9413
Requested NDC
58198-9413-1
Package NDCs from labels
58198-9413-1
Manufacturer
Elanco US Inc.
Effective date
2026-03-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Net Weight: 55 lb (25 kg) Denagard™ 80%Elanco US Inc.2026-03-06OTC ANIMAL DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58198-9413-1Denagard 80 coated Type A Medicated Article25 kg in 1 BAGPOWDER2513

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58198-9413DENAGARD 80 COATED TYPE A MEDICATED ARTICLE (TIAMULIN FUMARATE) POWDER [ELANCO US INC.]111 package rows20250114_37292c11-d37b-4001-924d-e42c0512c2e2.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TIAMULIN FUMARATEACTIVE INGREDIENTION1Q02ZCXDENAGARD 80 COATED TYPE A MEDICATED ARTICLE (TIAMULIN HYDROGEN FUMARATE) POWDER [NOVARTIS ANIMAL HEALTH US, INC.]4
TIAMULINACTIVE MOIETYE38WZ4U54RDENAGARD 80 COATED TYPE A MEDICATED ARTICLE (TIAMULIN HYDROGEN FUMARATE) POWDER [NOVARTIS ANIMAL HEALTH US, INC.]4

Reported adverse events (FAERS/openFDA)#

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