FDA.reportPublic FDA data

INFLIXIMAB - Food and Drug Administration

Manufacturer
Food and Drug Administration
Effective date
2025-07-21
Label type
Indexing - product concept
Version
1
Source
full-release
Hydrated at
2026-06-05 00:26:11

Label at a glance#

ProductINFLIXIMAB
Active ingredientINFLIXIMAB

DailyMed Biologic / Drug Substance Indexing#

Product, Base substance, Indexed substance code table
ProductBase substanceIndexed substance codeIndexed substanceApplicationIndexing SPLSPL versionEffective
IXIFIINFLIXIMABB72HH48FLU-QBTX-01infliximab-qbtxBLA76107250232590-361f-4d95-8f83-154c3e67119012017-12-13
RENFLEXISinfliximabB72HH48FLU-ABDA-01infliximab-abdaBLA761054246e76b1-174d-4160-abf2-4d293f03984612017-04-21
INFLECTRAinfliximabB72HH48FLU-DYYB-01infliximab-dyybBLA1255442b1f5f86-71db-4563-bc7f-d59f17389e9e12016-04-05

Products#

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

DailyMed product names page 1 of 1 · 1 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
INFLIXIMABB72HH48FLUACTIB

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
RenflexisINFLIXIMABOrganon LLCdbf738c4-3fac-4422-a9d8-51d9c83a87892026-08-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: INFLIXIMAB
INFLIXIMABINFLIXIMABJanssen Biotech, Inc.b05c174f-832c-4321-b34f-2c4ad37422692026-02-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: INFLIXIMAB
generic name: INFLIXIMAB
REMICADEINFLIXIMABJanssen Biotech, Inc.a0a046c1-056d-45a9-bfd9-13b47c24f2572025-06-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: INFLIXIMAB

Reported adverse events (FAERS/openFDA)#

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