Cefpodoxime Proxetil Tablet, Film Coated
NDC Package 68071-3441-2

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

Package Information

Cefpodoxime Proxetil tablets is a medication used to treat a wide variety of bacterial infections. This formulation utilizes a tablet, film coated delivery system. Marketed by Nucare Pharmaceuticals,inc., this product is identified by NDC 68071-3441 and is authorized under FDA application ANDA210568.

Identification & Billing

NDC Package Code
68071-3441-2
Package Description
20 TABLET, FILM COATED in 1 BOTTLE
Product Code
68071-3441
11-Digit Billing Format
68071344102
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cefpodoxime Proxetil
Non-Proprietary Name
Cefpodoxime Proxetil
Substance Name
Cefpodoxime Proxetil
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)
CEFPODOXIME PROXETIL 200 mg/1
Pharmacologic Class
Usage Information
This medication is used to treat a wide variety of bacterial infections. This medication is known as a cephalosporin 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
Nucare Pharmaceuticals,inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA210568
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-13-2023
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 68071-3441-2 identifies a specific commercial package of 20 tablet, film coated in 1 bottle of Cefpodoxime Proxetil, a human prescription drug labeled by Nucare Pharmaceuticals,inc.. This tablet, film coated is formulated for oral use and contains cefpodoxime proxetil 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 Nucare Pharmaceuticals,inc. on February 13, 2023. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat a wide variety of bacterial infections. This medication is known as a cephalosporin 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 Nucare Pharmaceuticals,inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68071344102. 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 (5-4-1)
68071-3441-2
11-Digit CMS (5-4-2)
68071-3441-02

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