FDA.reportPublic FDA data

Arikayce 70.3 MG/ML Inhalation Suspension

RxCUI
2059189
RxNorm name
Arikayce 70.3 MG/ML Inhalation Suspension
Display name
Arikayce 70.3 MG/ML Inhalation Suspension
Full name
Arikayce 70.3 MG/ML Inhalation Suspension
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:38:56

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
ARIKAYCEAMIKACINInsmed Incorporated499ab990-2b21-474f-aaba-d86388965f402026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2059189

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
499ab990-2b21-474f-aaba-d86388965f40ARIKAYCE 590 MG in 8.4 ML Inhalation Suspension [PSN] · amikacin liposomal 70.3 MG/ML Inhalation Suspension [Arikayce] [SBD] · ARIKAYCE 590 MG per 8.4 ML Inhalation Suspension [SY] · Arikayce 70.3 MG/ML Inhalation Suspension [SY]414These highlights do not include all the information needed to use ARIKAYCE safely and effectively. See full prescribing information for ARIKAYCE. ARIKAYCE ® (amikacin liposome inhalation suspension), for oral inhalation use Initial U.S. Approval: 2018 LIMITED POPULATION20251229