Home NDC 58198-8527 NDC 58198-8527 - Pradalex 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 58198-8527
Package NDCs from labels 58198-8527-1, 58198-8527-2
Manufacturer Elanco US Inc.
Effective date 2025-10-28
Current FDA listing Not matched in FDA.report NDC product tables DailyMed Labels# Label, Manufacturer, Effective date table Label Manufacturer Effective date Type Pradalex - Elanco US Inc. Elanco US Inc. 2025-10-28 PRESCRIPTION ANIMAL DRUG LABEL
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58198-8527-1 Pradalex 100 mL in 1 VIAL INJECTION, SOLUTION 100 4 58198-8527-1 Pradalex 1 in 1 CARTON INJECTION, SOLUTION 1 4 58198-8527-2 Pradalex 1 in 1 CARTON INJECTION, SOLUTION 1 4 58198-8527-2 Pradalex 250 mL in 1 VIAL INJECTION, SOLUTION 250 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58198-8527 PRADALEX (PRADOFLOXACIN) INJECTION, SOLUTION [ELANCO US INC.] 3 4 package rows 20250209_ffa8dfa6-7128-42ec-b35a-e774b58ec148.zip