Cefaclor
NDC Package 49884-080-01

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.

Cefaclor is a medication a cephalosporin-type antibiotic used to treat a wide variety of bacterial infections (e.g., middle ear, skin, urine and respiratory tract infections). Marketed by Par Pharmaceutical Inc., this product is identified by NDC 49884-080 and is authorized under FDA application ANDA065057.

Identification & Billing

NDC Package Code
49884-080-01
Package Description
100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Product Code
49884-080
11-Digit Billing Format
49884008001

Clinical Specifications

Proprietary Name
Cefaclor
Dosage Form
-
Usage Information
This medication is a cephalosporin-type antibiotic used to treat a wide variety of bacterial infections (e.g., middle ear, skin, urine and respiratory tract infections). It works by stopping the growth of bacteria. This antibiotic only treats bacterial infections. It will not work for viral infections (e.g., common cold, flu). Unnecessary use or overuse of any antibiotic can lead to its decreased effectiveness.

Regulatory & Marketing

Labeler Name
Par Pharmaceutical Inc.
FDA Application #
ANDA065057
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-14-2007
End Marketing Date
04-16-2009
Listing Expiration
04-16-2009
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 49884-080-01 identifies a specific commercial package of 100 tablet, film coated, extended release in 1 bottle of Cefaclor, labeled by Par Pharmaceutical 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 Par Pharmaceutical Inc. on November 14, 2007. The current certification is valid through April 16, 2009.

What are the primary indications for this medication?

This medication is a cephalosporin-type antibiotic used to treat a wide variety of bacterial infections (e.g., middle ear, skin, urine and respiratory tract infections). It works by stopping the growth of bacteria. This antibiotic only treats bacterial infections. It will not work for viral infections (e.g., common cold, flu). Unnecessary use or overuse of any antibiotic can lead to its decreased effectiveness.

How is this Par Pharmaceutical Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49884008001. 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)
49884-080-01
11-Digit CMS (5-4-2)
49884-0080-01

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