Clarithromycin
NDC Package 0185-0275-01

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.

Clarithromycin is used to treat a wide variety of bacterial infections. Marketed by Eon Labs, Inc., this product is identified by NDC 0185-0275 and is authorized under FDA application ANDA065250.

Identification & Billing

NDC Package Code
0185-0275-01
Package Description
100 TABLET, COATED in 1 BOTTLE
Product Code
0185-0275
11-Digit Billing Format
00185027501

Clinical Specifications

Proprietary Name
Clarithromycin Extended Release
Dosage Form
-
Usage Information
Clarithromycin is used to treat a wide variety of bacterial infections. This medication can also be used in combination with anti-ulcer medications to treat certain types of stomach ulcers. It may also be used to prevent certain bacterial infections. Clarithromycin is known as a macrolide antibiotic. It works by stopping the growth of bacteria. This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.

Regulatory & Marketing

Labeler Name
Eon Labs, Inc.
FDA Application #
ANDA065250
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-25-2005
End Marketing Date
03-31-2012
Listing Expiration
03-31-2012
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 (0185-0275). Click a package code to view its specific billing and regulatory data.

0185-0275-10
1000 TABLET, COATED in 1 BOTTLE
0185-0275-56
56 TABLET, COATED in 1 CARTON
0185-0275-60
60 TABLET, COATED in 1 BOTTLE

* 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 0185-0275-01 identifies a specific commercial package of 100 tablet, coated in 1 bottle of Clarithromycin Extended Release, labeled by Eon Labs, 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 Eon Labs, Inc. on August 25, 2005. The current certification is valid through March 31, 2012.

What are the primary indications for this medication?

Clarithromycin is used to treat a wide variety of bacterial infections. This medication can also be used in combination with anti-ulcer medications to treat certain types of stomach ulcers. It may also be used to prevent certain bacterial infections. Clarithromycin is known as a macrolide antibiotic. It works by stopping the growth of bacteria. This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.

How is this Eon Labs, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00185027501. 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)
0185-0275-01
11-Digit CMS (5-4-2)
00185-0275-01

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