Durezol
NDC Package 0078-0862-25

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 Novartis Pharmaceuticals Corporation, this product is identified by NDC 0078-0862 and is authorized under FDA application NDA022212.

Identification & Billing

NDC Package Code
0078-0862-25
Package Description
1 BOTTLE in 1 CARTON / 5 mL in 1 BOTTLE
Product Code
0078-0862
11-Digit Billing Format
00078086225
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

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
Novartis Pharmaceuticals Corporation
FDA Application #
NDA022212
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-25-2011
End Marketing Date
10-31-2025
Listing Expiration
10-31-2025
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 0078-0862-25 identifies a specific commercial package of 1 bottle in 1 carton / 5 ml in 1 bottle of Durezol, labeled by Novartis Pharmaceuticals Corporation. 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 Novartis Pharmaceuticals Corporation on January 25, 2011. The current certification is valid through October 31, 2025.

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 Novartis Pharmaceuticals Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00078086225. 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 (4-4-2)
0078-0862-25
11-Digit CMS (5-4-2)
00078-0862-25

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