FDA.reportPublic FDA data

iptacopan 200 MG Oral Capsule

RxCUI
2671074
RxNorm name
iptacopan 200 MG Oral Capsule
Display name
iptacopan 200 MG Oral Capsule
Full name
iptacopan 200 MG Oral Capsule
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:39:13

RxNav Current And Historical NDCs#

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UNII Substances#

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openFDA label cross-check#

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FABHALTAIPTACOPANNovartis Pharmaceuticals Corporationa76b5845-6e21-4d3b-ad07-cd8df1b60bee2026-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2671074

Reported adverse events (FAERS/openFDA)#

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

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
a76b5845-6e21-4d3b-ad07-cd8df1b60beeiptacopan 200 MG Oral Capsule [PSN] · iptacopan 200 MG Oral Capsule [SCD] · iptacopan 200 MG (as iptacopan hydrochloride 225.8 MG) Oral Capsule [SY]34These highlights do not include all the information needed to use FABHALTA safely and effectively. See full prescribing information for FABHALTA. FABHALTA ® (iptacopan) capsules, for oral use Initial U.S. Approval: 202320250320