FDA.reportPublic FDA data

Fabhalta 200 MG (as iptacopan hydrochloride 225.8 MG) Oral Capsule

RxCUI
2671080
RxNorm name
Fabhalta 200 MG (as iptacopan hydrochloride 225.8 MG) Oral Capsule
Display name
Fabhalta 200 MG (as iptacopan hydrochloride 225.8 MG) Oral Capsule
Full name
Fabhalta 200 MG (as iptacopan hydrochloride 225.8 MG) Oral Capsule
Term type
SY
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: 2671080

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-cd8df1b60beeFABHALTA 200 MG Oral Capsule [PSN] · iptacopan 200 MG Oral Capsule [Fabhalta] [SBD] · Fabhalta 200 MG (as iptacopan hydrochloride 225.8 MG) Oral Capsule [SY] · Fabhalta 200 MG Oral Capsule [SY]44These 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