Cayston Kit
NDC Package 61958-0901-1

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

Cayston (aztreonam) kits is a medication used to treat people with a certain inherited condition (cystic fibrosis) who have a persistent lung infection with a certain bacteria (Pseudomonas aeruginosa). This formulation utilizes a kit delivery system. Marketed by Gilead Sciences, Inc., this product is identified by NDC 61958-0901 and is authorized under FDA application NDA050814.

Identification & Billing

NDC Package Code
61958-0901-1
Package Description
2 CARTON in 1 PACKAGE / 1 KIT in 1 CARTON * 1 mL in 1 VIAL * 1 mL in 1 AMPULE
Product Code
11-Digit Billing Format
61958090101
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cayston
Non-Proprietary Name
Aztreonam
Dosage Form
Kit - A packaged collection of related material.
Usage Information
This medication is used to treat people with a certain inherited condition (cystic fibrosis) who have a persistent lung infection with a certain bacteria (Pseudomonas aeruginosa). People with cystic fibrosis produce thick, sticky mucus that can plug up the tubes, ducts and passageways in the lungs. This can result in serious breathing problems and infections in the lungs. Aztreonam belongs to a class of drugs known as beta-lactams. Aztreonam inhalation solution works by stopping the growth of a certain bacteria (Pseudomonas aeruginosa) that commonly infects the lungs of people with cystic fibrosis. This effect decreases lung infections and damage, decreases the use of other antibiotics, and helps to improve breathing. This antibiotic treats only bacterial infections. It will not work for viral infections (such as the common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.

Regulatory & Marketing

Labeler Name
Gilead Sciences, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA050814
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-22-2010
Listing Expiration
12-31-2026
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 61958-0901-1 identifies a specific commercial package of 2 carton in 1 package / 1 kit in 1 carton * 1 ml in 1 vial * 1 ml in 1 ampule of Cayston, a human prescription drug labeled by Gilead Sciences, Inc.. This kit is formulated for use and contains 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 Gilead Sciences, Inc. on February 22, 2010. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat people with a certain inherited condition (cystic fibrosis) who have a persistent lung infection with a certain bacteria (Pseudomonas aeruginosa). People with cystic fibrosis produce thick, sticky mucus that can plug up the tubes, ducts and passageways in the lungs. This can result in serious breathing problems and infections in the lungs. Aztreonam belongs to a class of drugs known as beta-lactams. Aztreonam inhalation solution works by stopping the growth of a certain bacteria (Pseudomonas aeruginosa) that commonly infects the lungs of people with cystic fibrosis. This effect decreases lung infections and damage, decreases the use of other antibiotics, and helps to improve breathing. This antibiotic treats only bacterial infections. It will not work for viral infections (such as the common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.

How is this Gilead Sciences, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61958090101. 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 (5-4-1)
61958-0901-1
11-Digit CMS (5-4-2)
61958-0901-01

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