FDA.reportPublic FDA data

infliximab-dyyb 100 MG Injection [Inflectra]

RxCUI
1790546
RxNorm name
infliximab-dyyb 100 MG Injection [Inflectra]
Display name
infliximab-dyyb 100 MG Injection [Inflectra]
Full name
infliximab-dyyb 100 MG Injection [Inflectra]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:38:54

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125544Inflectrainfliximab-dyyb351(k) BiosimilarRx2026-07-01

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
INFLECTRAINFLIXIMAB-DYYBPfizer Laboratories Div Pfizer Inc37eaca10-d812-48bc-8b8e-b836bfa9968f2026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1790546

DailyMed RxNorm Mappings#

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

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
37eaca10-d812-48bc-8b8e-b836bfa9968fINFLECTRA 100 MG Injection [PSN] · infliximab-dyyb 100 MG Injection [Inflectra] [SBD] · Inflectra 100 MG Injection [SY]323These highlights do not include all the information needed to use INFLECTRA safely and effectively. See full prescribing information for INFLECTRA. INFLECTRA ® (infliximab-dyyb) for injection, for intravenous use Initial U.S. Approval: 2016 INFLECTRA (infliximab-dyyb) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful diffe20250910