NDC 71558-590

ARIKAYCE

Amikacin

ARIKAYCE is a Respiratory (inhalation) Suspension in the Human Prescription Drug category. It is labeled and distributed by Insmed Incorporated. The primary component is Amikacin.

Product ID71558-590_14dd25e2-15ac-424b-b444-ab7867814d85
NDC71558-590
Product TypeHuman Prescription Drug
Proprietary NameARIKAYCE
Generic NameAmikacin
Dosage FormSuspension
Route of AdministrationRESPIRATORY (INHALATION)
Marketing Start Date2018-10-12
Marketing CategoryNDA / NDA
Application NumberNDA207356
Labeler NameInsmed Incorporated
Substance NameAMIKACIN
Active Ingredient Strength590 mg/8.4mL
Pharm ClassesAminoglycoside Antibacterial [EPC],Aminoglycosides [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 71558-590-28

28 VIAL in 1 CARTON (71558-590-28) > 8.4 mL in 1 VIAL
Marketing Start Date2018-10-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71558-590-28 [71558059028]

ARIKAYCE SUSPENSION
Marketing CategoryNDA
Application NumberNDA207356
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-10-12

Drug Details

Active Ingredients

IngredientStrength
AMIKACIN590 mg/8.4mL

OpenFDA Data

SPL SET ID:499ab990-2b21-474f-aaba-d86388965f40
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2059189
  • 2059184
  • Pharmacological Class

    • Aminoglycoside Antibacterial [EPC]
    • Aminoglycosides [CS]

    Trademark Results [ARIKAYCE]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ARIKAYCE
    ARIKAYCE
    87316222 not registered Dead/Abandoned
    Insmed, Inc.
    2017-01-27
    ARIKAYCE
    ARIKAYCE
    85972453 5166666 Live/Registered
    Insmed, Inc.
    2013-06-28

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