FDA.reportPublic FDA data

NDC 58198-0023 - Baytril

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
58198-0023
Package NDCs from labels
58198-0023-1, 58198-0023-2
Manufacturer
Elanco US Inc.
Effective date
2025-01-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Approved by FDA under NADA # 140-441Elanco US Inc.2025-01-24PRESCRIPTION ANIMAL DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58198-0023-1Baytril50 in 1 BOTTLETABLET, COATED504
58198-0023-2Baytril250 in 1 BOTTLETABLET, COATED2504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58198-0023BAYTRIL (ENROFLOXACIN) TABLET, COATED [ELANCO US INC.]42 package rows20250206_12b5d3c7-d539-4bc2-aa47-4516c36967f3.zip

Reported adverse events (FAERS/openFDA)#

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