FDA.reportPublic FDA data

infliximab 100 MG Injection

RxCUI
310994
RxNorm name
infliximab 100 MG Injection
Display name
infliximab 100 MG Injection
Full name
infliximab 100 MG Injection
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:39:11

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103772Remicadeinfliximab351(a)Rx2026-07-01

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
INFLIXIMABINFLIXIMABJanssen Biotech, Inc.b05c174f-832c-4321-b34f-2c4ad37422692026-02-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310994
REMICADEINFLIXIMABJanssen Biotech, Inc.a0a046c1-056d-45a9-bfd9-13b47c24f2572025-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310994

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 2 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
a0a046c1-056d-45a9-bfd9-13b47c24f257inFLIXimab 100 MG Injection [PSN] · infliximab 100 MG Injection [SCD] · infliximab 100 MG per 10 ML Injection [SY]337These highlights do not include all the information needed to use REMICADE safely and effectively. See full prescribing information for REMICADE. REMICADE ® (infliximab) for injection, for intravenous use Initial U.S. Approval: 199820250603
b05c174f-832c-4321-b34f-2c4ad3742269inFLIXimab 100 MG Injection [PSN] · infliximab 100 MG Injection [SCD] · infliximab 100 MG per 10 ML Injection [SY]35These highlights do not include all the information needed to use INFLIXIMAB safely and effectively. See full prescribing information for INFLIXIMAB. INFLIXIMAB for injection, for intravenous use Initial U.S. Approval: 199820260211