Durezol
NDC Package 42826-601-05

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

Package Information

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

Durezol is a medication used to treat swelling and pain after eye surgery. Marketed by Sirion Therapeutics, Inc., this product is identified by NDC 42826-601 and is authorized under FDA application NDA022212.

Identification & Billing

NDC Package Code
42826-601-05
Package Description
1 BOTTLE in 1 CARTON / 5 mL in 1 BOTTLE
Product Code
42826-601
11-Digit Billing Format
42826060105

Clinical Specifications

Proprietary Name
Durezol
Dosage Form
-
Usage Information
This medication is used to treat swelling and pain after eye surgery. It may also be used to treat a certain serious eye problem (endogenous anterior uveitis). This medication belongs to a class of drugs known as corticosteroids.

Regulatory & Marketing

Labeler Name
Sirion Therapeutics, Inc.
FDA Application #
NDA022212
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-01-2008
End Marketing Date
06-24-2010
Listing Expiration
06-24-2010
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 42826-601-05 identifies a specific commercial package of 1 bottle in 1 carton / 5 ml in 1 bottle of Durezol, labeled by Sirion Therapeutics, 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 Sirion Therapeutics, Inc. on September 01, 2008. The current certification is valid through June 24, 2010.

What are the primary indications for this medication?

This medication is used to treat swelling and pain after eye surgery. It may also be used to treat a certain serious eye problem (endogenous anterior uveitis). This medication belongs to a class of drugs known as corticosteroids.

How is this Sirion Therapeutics, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42826060105. 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)
42826-601-05
11-Digit CMS (5-4-2)
42826-0601-05

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