NDC 58198-5315-2 - Bexacat

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
58198-5315
Requested NDC
58198-5315-2
Package NDCs from labels
58198-5315-1, 58198-5315-2
Manufacturer
Elanco US Inc.
Effective date
2026-05-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Elanco TM Bexacat TM (bexagliflozin tablets)Elanco US Inc.2026-05-19PRESCRIPTION ANIMAL DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58198-5315-1Bexacat1 in 1 CARTONTABLET13
58198-5315-1Bexacat30 in 1 BOTTLETABLET303
58198-5315-2Bexacat90 in 1 BOTTLETABLET903
58198-5315-2Bexacat1 in 1 CARTONTABLET13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58198-5315BEXACAT (BEXAGLIFLOZIN TABLETS) TABLET [ELANCO US INC.]24 package rows20230215_f918583d-0337-40da-8da1-1e1320b8d027.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 ยท 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BexagliflozinBEXAGLIFLOZINGolden State Medical Supply, Inc.1a3ba9d5-1009-bad0-e063-6294a90ac4cc2026-07-30Warnings, Adverse reactionsExact identifier
unii: EY00JF42FV
BexagliflozinBEXAGLIFLOZINTheracosBio, LLC7f0ad5d2-3509-4057-904c-d27993de74082026-06-23Warnings, Adverse reactionsExact identifier
unii: EY00JF42FV
BRENZAVVYBEXAGLIFLOZINTheracosBio, LLC3cdf28fc-4194-4ad6-aa03-c9eaa68da83e2026-06-10Warnings, Adverse reactionsExact identifier
unii: EY00JF42FV

Reported adverse events (FAERS/openFDA)#

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