Arikayce Suspension
NDC Package 71558-590-28

11-digit billing NDC: 71558059028 · Billing unit: ML · 235.2 ML per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Arikayce (amikacin) suspension is lIMITED POPULATION: ARIKAYCE® is indicated in adults, who have limited or no alternative treatment options, for the treatment of Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen in patients who do not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy. This formulation utilizes a suspension delivery system. Marketed by Insmed Incorporated, this product is identified by NDC 71558-590 and is authorized under FDA application NDA207356.

Identification & Billing

NDC Package Code
71558-590-28
Package Description
28 VIAL in 1 CARTON / 8.4 mL in 1 VIAL
Product Code
71558-590
11-Digit Billing Format
71558059028
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
235.2 ML
RxNorm Crosswalk
  • RxCUI: 2059184 - amikacin liposomal 590 MG in 8.4 ML Inhalation Suspension
  • RxCUI: 2059184 - amikacin liposomal 70.3 MG/ML Inhalation Suspension
  • RxCUI: 2059184 - amikacin liposomal 590 MG per 8.4 ML Inhalation Suspension
  • RxCUI: 2059189 - ARIKAYCE 590 MG in 8.4 ML Inhalation Suspension
  • RxCUI: 2059189 - amikacin liposomal 70.3 MG/ML Inhalation Suspension [Arikayce]

Clinical Specifications

Proprietary Name
Arikayce
Non-Proprietary Name
Amikacin
Substance Name
Amikacin
Dosage Form
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Administration Route
Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.
Active Ingredient(s)
AMIKACIN 590 mg/8.4mL
Pharmacologic Class
Usage Information
LIMITED POPULATION: ARIKAYCE® is indicated in adults, who have limited or no alternative treatment options, for the treatment of Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen in patients who do not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy. As only limited clinical safety and effectiveness data for ARIKAYCE are currently available, reserve ARIKAYCE for use in adults who have limited or no alternative treatment options. This drug is indicated for use in a limited and specific population of patients.This indication is approved under accelerated approval based on achieving sputum culture conversion (defined as 3 consecutive negative monthly sputum cultures) by Month 6. Clinical benefit has not yet been established [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Regulatory & Marketing

Labeler Name
Insmed Incorporated
Product Type
Human Prescription Drug
FDA Application #
NDA207356
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-12-2018
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 71558-590-28 identifies a specific commercial package of 28 vial in 1 carton / 8.4 ml in 1 vial of Arikayce, a human prescription drug labeled by Insmed Incorporated. This product is billed per "ML" milliliter and contains an estimated amount of 235.2 billable units per package. This suspension is formulated for respiratory (inhalation) use and contains amikacin as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Insmed Incorporated on October 12, 2018. The current certification is valid through December 31, 2027.

How is this Insmed Incorporated product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71558059028. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 235.2 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
71558-590-28
11-Digit CMS (5-4-2)
71558-0590-28

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.