Cayston Kit
NDC Package 61958-0901-1
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
- RxCUI: 901610 - aztreonam 75 MG/ML Inhalation Solution
- RxCUI: 901614 - Cayston 75 MG/ML Inhalation Solution
- RxCUI: 901614 - aztreonam 75 MG/ML Inhalation Solution [Cayston]
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 61958 - Gilead Sciences, Inc.
- 61958-0901 - Cayston
- 61958-0901-1 - 2 CARTON in 1 PACKAGE / 1 KIT in 1 CARTON * 1 mL in 1 VIAL * 1 mL in 1 AMPULE
- 61958-0901 - Cayston
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.
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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:
Note: The zero is added to the Package segment to maintain the 5-4-2 structure.