FDA.reportPublic FDA data

Fluralaner LPS

Manufacturer
F.I.S. - Fabbrica Italiana Sintetici S.p.A.
Effective date
2024-10-28
Label type
BULK INGREDIENT - ANIMAL DRUG
Version
4
Source
full-release
Hydrated at
2026-06-01 02:51:14

Label at a glance#

ProductFluralaner LPS
Active ingredientFLURALANER
Label structure2 sections

Label contents#

Full prescribing information#

Fluralaner LPS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fluralaner LPSFluralaner LPS

0581_U3

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

0581_U30581_U3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52133-0048-0Fluralaner LPS50 kg in 1 DRUMPOWDER504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52133-0048FLURALANER LPS POWDER [F.I.S. - FABBRICA ITALIANA SINTETICI S.P.A.]41 package rows20241030_65aeff86-a830-4c73-b727-3d61a07e348f.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52133-004852133-0048-0

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
FLURALANERWSH8393RM5ACTIB

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

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