Clarithromycin Tablet, Film Coated
NDC Package 82804-141-28

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

Clarithromycin tablets is clarithromycin is used to treat a wide variety of bacterial infections. This formulation utilizes a tablet, film coated delivery system. Marketed by Proficient Rx Lp, this product is identified by NDC 82804-141 and is authorized under FDA application ANDA065489.

Identification & Billing

NDC Package Code
82804-141-28
Package Description
28 TABLET, FILM COATED in 1 BOTTLE
Product Code
82804-141
11-Digit Billing Format
82804014128
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
28 EA
RxNorm Crosswalk
RxCUI: 197517 - clarithromycin 500 MG Oral Tablet

Clinical Specifications

Proprietary Name
Clarithromycin
Non-Proprietary Name
Clarithromycin
Substance Name
Clarithromycin
Dosage Form
Tablet, Film Coated - 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.
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
Proficient Rx Lp
Product Type
Human Prescription Drug
FDA Application #
ANDA065489
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-25-2012
Listing Expiration
12-31-2027
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (82804-141). Click a package code to view its specific billing and regulatory data.

82804-141-14
14 TABLET, FILM COATED in 1 BOTTLE
82804-141-20
20 TABLET, FILM 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 82804-141-28 identifies a specific commercial package of 28 tablet, film coated in 1 bottle of Clarithromycin, a human prescription drug labeled by Proficient Rx Lp. This product is billed for "EA" each discreet unit and contains an estimated amount of 28 billable units per package. This tablet, film coated 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 Proficient Rx Lp on July 25, 2012. The current certification is valid through December 31, 2027.

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 Proficient Rx Lp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 82804014128. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 28 total billable units per package. 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)
82804-141-28
11-Digit CMS (5-4-2)
82804-0141-28

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