FDA.reportPublic FDA data

IBUTILIDE FUMARATE - Food and Drug Administration

Manufacturer
Food and Drug Administration
Effective date
2025-01-28
Label type
Indexing - Product Concept
Version
2
Source
full-release
Hydrated at
2026-06-05 00:25:04

Label at a glance#

ProductIBUTILIDE FUMARATE
Active ingredientIBUTILIDE FUMARATE

Products#

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

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

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
IBUTILIDE FUMARATE9L5X4M5L6IACTIB

Source Document#

Source XML

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ibutilide FumarateIBUTILIDE FUMARATEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.0cf8724a-f0d1-4ce2-b7c1-cf5fac345fd02025-11-04Warnings, Adverse reactionsName fallback
brand name: Ibutilide Fumarate
generic name: IBUTILIDE FUMARATE
CorvertIBUTILIDE FUMARATEPharmacia & Upjohn Company LLC2428969a-7431-4e94-9503-ad5c680e2ea42024-01-25Boxed warning, Warnings, Adverse reactionsName fallback
generic name: IBUTILIDE FUMARATE
CorvertIBUTILIDE FUMARATEPharmacia & Upjohn Company LLCb7d717ed-022d-4459-b5e6-098c2a8b74272024-01-25Boxed warning, Warnings, Adverse reactionsName fallback
generic name: IBUTILIDE FUMARATE

Reported adverse events (FAERS/openFDA)#

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