Arikayce Suspension
NDC Package 71558-590-28

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Arikayce (amikacin) suspension is a medication used along with other medications to treat a certain lung infection (Mycobacterium avium complex-MAC) after other treatments have not worked. 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.

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
This medication is used along with other medications to treat a certain lung infection (Mycobacterium avium complex-MAC) after other treatments have not worked. Amikacin belongs to a class of drugs known as aminoglycoside antibiotics. This medication works by stopping the growth of bacteria. This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.

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 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.

What are the primary indications for this medication?

This medication is used along with other medications to treat a certain lung infection (Mycobacterium avium complex-MAC) after other treatments have not worked. Amikacin belongs to a class of drugs known as aminoglycoside antibiotics. This medication works by stopping the growth of bacteria. This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.

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.. 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.