FDA.reportPublic FDA data

ivacaftor 188 MG / lumacaftor 150 MG Oral Granules [ORKAMBI]

RxCUI
2053519
RxNorm name
ivacaftor 188 MG / lumacaftor 150 MG Oral Granules [ORKAMBI]
Display name
ivacaftor 188 MG / lumacaftor 150 MG Oral Granules [ORKAMBI]
Full name
ivacaftor 188 MG / lumacaftor 150 MG Oral Granules [ORKAMBI]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:38:55

RxNav Current And Historical NDCs#

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No records found.

UNII Substances#

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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
ORKAMBILUMACAFTOR AND IVACAFTORVertex Pharmaceuticals Incorporated3fc1c40e-cfac-47a1-9e1a-61ead35706002026-03-24Warnings, Adverse reactionsExact identifier
rxcui: 2053519

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-61ead3570600ORKAMBI 150 MG / 188 MG Oral Granules [PSN] · ivacaftor 188 MG / lumacaftor 150 MG Oral Granules [ORKAMBI] [SBD] · ORKAMBI (ivacaftor 188 MG / lumacaftor 150 MG) Oral Granules [SY]324These 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