Azasite
NDC Package 31357-040-04

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Azasite is a medication used to treat certain eye infections. Marketed by Inspire Pharmaceuticals, Inc., this product is identified by NDC 31357-040 and is authorized under FDA application NDA050810.

Identification & Billing

NDC Package Code
31357-040-04
Package Description
1 BOTTLE, DROPPER in 1 CARTON / 1 mL in 1 BOTTLE, DROPPER
Product Code
31357-040
11-Digit Billing Format
31357004004

Clinical Specifications

Proprietary Name
Azasite
Dosage Form
-
Usage Information
This medication is used to treat certain eye infections. It is a macrolide antibiotic that works by stopping the growth of bacteria. This medication treats only bacterial eye infections. It will not work for other types of eye infections. Unnecessary use or misuse of any antibiotic can lead to its decreased effectiveness.

Regulatory & Marketing

Labeler Name
Inspire Pharmaceuticals, Inc.
FDA Application #
NDA050810
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-16-2007
End Marketing Date
08-31-2015
Listing Expiration
08-31-2015
Exclude Flag
D
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (31357-040). Click a package code to view its specific billing and regulatory data.

31357-040-02
1 BOTTLE, DROPPER in 1 CARTON / .65 mL in 1 BOTTLE, DROPPER
31357-040-03
1 BOTTLE, DROPPER in 1 CARTON / 2.5 mL in 1 BOTTLE, DROPPER
31357-040-25
1 BOTTLE, DROPPER in 1 CARTON / 2.5 mL in 1 BOTTLE, DROPPER

* 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 31357-040-04 identifies a specific commercial package of 1 bottle, dropper in 1 carton / 1 ml in 1 bottle, dropper of Azasite, labeled by Inspire Pharmaceuticals, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Inspire Pharmaceuticals, Inc. on July 16, 2007. The current certification is valid through August 31, 2015.

What are the primary indications for this medication?

This medication is used to treat certain eye infections. It is a macrolide antibiotic that works by stopping the growth of bacteria. This medication treats only bacterial eye infections. It will not work for other types of eye infections. Unnecessary use or misuse of any antibiotic can lead to its decreased effectiveness.

How is this Inspire Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 31357004004. 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)
31357-040-04
11-Digit CMS (5-4-2)
31357-0040-04

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