FDA.reportPublic FDA data

ivacaftor 75 MG / tezacaftor 50 MG Oral Tablet

RxCUI
2174387
RxNorm name
ivacaftor 75 MG / tezacaftor 50 MG Oral Tablet
Display name
ivacaftor 75 MG / tezacaftor 50 MG Oral Tablet
Full name
ivacaftor 75 MG / tezacaftor 50 MG Oral Tablet
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:38:52

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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
302ae804-37db-44fd-ac2f-3dbdeda9aa4bivacaftor 75 MG / tezacaftor 50 MG Oral Tablet [PSN] · ivacaftor 75 MG / tezacaftor 50 MG Oral Tablet [SCD]221These highlights do not include all the information needed to use SYMDEKO safely and effectively. See full prescribing information for SYMDEKO. SYMDEKO ® (tezacaftor/ivacaftor) tablets; (ivacaftor) tablets, for oral use Initial U.S. Approval: 201820260324