FDA.reportPublic FDA data

lumacaftor 200 MG / ivacaftor 125 MG Oral Tablet

RxCUI
1655928
RxNorm name
lumacaftor 200 MG / ivacaftor 125 MG Oral Tablet
Display name
lumacaftor 200 MG / ivacaftor 125 MG Oral Tablet
Full name
lumacaftor 200 MG / ivacaftor 125 MG Oral Tablet
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:38:55

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ORKAMBILUMACAFTOR AND IVACAFTORVertex Pharmaceuticals Incorporated3fc1c40e-cfac-47a1-9e1a-61ead35706002026-03-24Warnings, Adverse reactionsExact identifier
rxcui: 1655928

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
3fc1c40e-cfac-47a1-9e1a-61ead3570600lumacaftor 200 MG / ivacaftor 125 MG Oral Tablet [PSN] · ivacaftor 125 MG / lumacaftor 200 MG Oral Tablet [SCD]224These highlights do not include all the information needed to use ORKAMBI safely and effectively. See full prescribing information for ORKAMBI. ORKAMBI ® (lumacaftor and ivacaftor) tablets, for oral use ORKAMBI ® (lumacaftor and ivacaftor) oral granules Initial U.S. Approval: 201520260324