FDA.reportPublic FDA data

NDC 58198-4875-1 - Onsior

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
58198-4875
Requested NDC
58198-4875-1
Package NDCs from labels
58198-4875-1
Manufacturer
Elanco US Inc.
Effective date
2026-05-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
onsior™ (robenacoxib) 6 mg Tablets for CatsElanco US Inc.2026-05-22PRESCRIPTION ANIMAL DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58198-4875-1Onsior3 in 1 BLISTER PACKTABLET35
58198-4875-1Onsior10 in 1 CARTONTABLET105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58198-4875ONSIOR (ROBENACOXIB) TABLET [ELANCO US INC.]42 package rows20241025_922d3235-085e-454f-9535-44ef4bca12f4.zip

Reported adverse events (FAERS/openFDA)#

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