Manufacturing Establishments8
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Wickham Micro Limited
Insmed Incorporated
228216353
ACS Dobfar S.p.A.
Insmed Incorporated
366662773
Resilience Biotechnologies Inc.
Insmed Incorporated
243669426
LabCorp Early Development Laboratories Limited
Insmed Incorporated
213137276
Alcami Carolinas Corporation
Insmed Incorporated
831351445
PPD Development Ireland Ltd
Insmed Incorporated
985036175
Sharp Packaging Services, LLC
Insmed Incorporated
143696495
Charles River Laboratories Ireland Limited
Insmed Incorporated
988712659
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ARIKAYCE
Product Details
NDC Product Code
71558-590Application Number
NDA207356Marketing Category
NDA (C73594)Route of Administration
RESPIRATORY (INHALATION)Effective Date
February 8, 2023AmikacinActive
Code: 84319SGC3CClass: ACTIBQuantity: 590 mg in 8.4 mL
CholesterolInactive
Code: 97C5T2UQ7JClass: IACT
DIPALMITOYLPHOSPHATIDYLCHOLINE, DL-Inactive
Code: 2W15RT5V7VClass: IACT
Sodium HydroxideInactive
Code: 55X04QC32IClass: IACT
WaterInactive
Code: 059QF0KO0RClass: IACT
Sodium ChlorideInactive
Code: 451W47IQ8XClass: IACT