ARIKAYCE
These 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 POPULATION
Approved
Approval ID
499ab990-2b21-474f-aaba-d86388965f40
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 8, 2023
Manufacturers
FDA
Insmed Incorporated
DUNS: 183470066
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Amikacin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71558-590
Application NumberNDA207356
Product Classification
M
Marketing Category
C73594
G
Generic Name
Amikacin
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateFebruary 8, 2023
FDA Product Classification
INGREDIENTS (6)
AmikacinActive
Quantity: 590 mg in 8.4 mL
Code: 84319SGC3C
Classification: ACTIB
CholesterolInactive
Code: 97C5T2UQ7J
Classification: IACT
DIPALMITOYLPHOSPHATIDYLCHOLINE, DL-Inactive
Code: 2W15RT5V7V
Classification: IACT
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Sodium ChlorideInactive
Code: 451W47IQ8X
Classification: IACT