Clarithromycin Tablet, Film Coated, Extended Release
NDC Package 0591-2805-60

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

Package Information

Clarithromycin tablets is clarithromycin is used to treat a wide variety of bacterial infections. This formulation utilizes a tablet, film coated, extended release delivery system. Marketed by Actavis Pharma, Inc., this product is identified by NDC 0591-2805 and is authorized under FDA application ANDA065145.

Identification & Billing

NDC Package Code
0591-2805-60
Package Description
60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
Product Code
0591-2805
11-Digit Billing Format
00591280560
RxNorm Crosswalk
  • RxCUI: 359385 - clarithromycin 500 MG 24HR Extended Release Oral Tablet
  • RxCUI: 359385 - 24 HR clarithromycin 500 MG Extended Release Oral Tablet
  • RxCUI: 359385 - clarithromycin 500 MG 24 HR Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Clarithromycin
Non-Proprietary Name
Clarithromycin
Substance Name
Clarithromycin
Dosage Form
Tablet, Film Coated, Extended Release - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer; the tablet is formulated in such manner as to make the contained medicament available over an extended period of time following ingestion.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
CLARITHROMYCIN 500 mg/1
Pharmacologic Class
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
Actavis Pharma, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA065145
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-27-2014
Listing Expiration
12-31-2026
Exclude Flag
N
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 0591-2805-60 identifies a specific commercial package of 60 tablet, film coated, extended release in 1 bottle, plastic of Clarithromycin, a human prescription drug labeled by Actavis Pharma, Inc.. This tablet, film coated, extended release is formulated for oral use and contains clarithromycin 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 Actavis Pharma, Inc. on February 27, 2014. The current certification is valid through December 31, 2026.

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 Actavis Pharma, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00591280560. 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)
0591-2805-60
11-Digit CMS (5-4-2)
00591-2805-60

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