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 ID: 71558-590_14dd25e2-15ac-424b-b444-ab7867814d85
• NDC: 71558-590
• Product Type: Human Prescription Drug
• Proprietary Name: ARIKAYCE
• Generic Name: Amikacin
• Dosage Form: Suspension
• Route of Administration: RESPIRATORY (INHALATION)
• Marketing Start Date: 2018-10-12
• Marketing Category: NDA / NDA
• Application Number: NDA207356
• Labeler Name: Insmed Incorporated
• Substance Name: AMIKACIN
• Active Ingredient Strength: 590 mg/8.4mL
• Pharm Classes: Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 71558-590-28

28 VIAL in 1 CARTON (71558-590-28) > 8.4 mL in 1 VIAL

• Marketing Start Date: 2018-10-12
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 71558-590-28 [71558059028]

ARIKAYCE SUSPENSION

• Marketing Category: NDA
• Application Number: NDA207356
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-10-12

Drug Details

Active Ingredients

Ingredient	Strength
AMIKACIN	590 mg/8.4mL

OpenFDA Data

• SPL SET ID: 499ab990-2b21-474f-aaba-d86388965f40
• Manufacturer:
  • Insmed Incorporated
• UNII:
  • 84319SGC3C
• RxNorm Concept Unique ID - RxCUI:
  • 2059189
  • 2059184

Pharmacological Class

• Aminoglycoside Antibacterial [EPC]
• Aminoglycosides [CS]