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#

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.

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Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FABHALTA	IPTACOPAN	Novartis Pharmaceuticals Corporation	a76b5845-6e21-4d3b-ad07-cd8df1b60bee	2026-07-16	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 2671080

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set ID	RxNorm string	TTY	SPL version	Label	Effective
a76b5845-6e21-4d3b-ad07-cd8df1b60bee	Fabhalta 200 MG (as iptacopan hydrochloride 225.8 MG) Oral Capsule	SY	4	These 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: 2023	20250320
a76b5845-6e21-4d3b-ad07-cd8df1b60bee	iptacopan 200 MG Oral Capsule [Fabhalta]	SBD	4	These 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: 2023	20250320
a76b5845-6e21-4d3b-ad07-cd8df1b60bee	Fabhalta 200 MG Oral Capsule	SY	4	These 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: 2023	20250320
a76b5845-6e21-4d3b-ad07-cd8df1b60bee	FABHALTA 200 MG Oral Capsule	PSN	4	These 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: 2023	20250320