Cefpodoxime Proxetil Tablet, Film Coated
NDC Package 67296-2347-1

11-digit billing NDC: 67296234701
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Cefpodoxime Proxetil tablets is cefpodoxime proxetil is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.  Recommended dosages, durations of therapy, and applicable patient populations vary among these infections. This formulation utilizes a tablet, film coated delivery system. Marketed by Redpharm Drug, this product is identified by NDC 67296-2347 and is authorized under FDA application ANDA065370.

Identification & Billing

NDC Package Code
67296-2347-1
Package Description
10 TABLET, FILM COATED in 1 BOTTLE
Product Code
67296-2347
11-Digit Billing Format
67296234701

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 100 mg/1
Pharmacologic Class
Usage Information
Cefpodoxime proxetil is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.  Recommended dosages, durations of therapy, and applicable patient populations vary among these infections. Please see DOSAGE AND ADMINISTRATIONfor specific recommendations. Acute otitis mediacaused by Streptococcus pneumoniae(excluding penicillin-resistant strains), Streptococcus pyogenes, Haemophilus influenzae(including beta-lactamase-producing strains), or Moraxella (Branhamella)catarrhalis(including beta-lactamase-producing strains).  Pharyngitis and/or tonsillitiscaused by Streptococcus pyogenes. NOTE: Only penicillin by the intramuscular route of administration has been shown to be effective in the prophylaxis of rheumatic fever. Cefpodoxime proxetil is generally effective in the eradication of  streptococci from the oropharynx. However, data establishing the efficacy of cefpodoxime proxetil for the prophylaxis of subsequent rheumatic fever are not available. Community-acquired pneumonia caused by S. pneumoniaeor H. Influenzae(including beta-lactamase-producing strains).  Acute bacterial exacerbation of chronic bronchitis caused by S. pneumoniae, H. influenzae(non-beta-lactamase-producing strains only), or M. catarrhalis. Data are insufficient at this time to establish efficacy in patients with acute bacterial exacerbations of chronic bronchitis caused by beta-lactamase-producing strains of H. influenzae.  Acute, uncomplicated urethral and cervical gonorrhea  caused by Neisseria gonorrhoeae(including penicillinase-producing strains).  Acute, uncomplicated ano-rectal infections in women  due to Neisseria gonorrhoeae(including penicillinase-producing strains).  NOTE:The efficacy of cefpodoxime in treating male patients with rectal infections caused by N. gonorrhoeaehas not been established. Data do not support the use of cefpodoxime proxetil in the treatment of pharyngeal infections due to N. gonorrhoeaein men or women.  Uncomplicated skin and skin structure infections caused by Staphylococcus aureus(including penicillinase-producing strains) or Streptococcus pyogenes. Abscesses should be surgically drained as clinically indicated.  NOTE: In clinical trials, successful treatment of uncomplicated skin and skin structure infections was dose-related. The effective therapeutic dose for skin infections was higher than those used in other recommended indications. (See DOSAGE AND ADMINISTRATION.)  Acute maxillary sinusitis  caused by Haemophilus influenzae(including beta-lactamase-producing strains), Streptococcus pneumoniae, and Moraxella catarrhalis.  Uncomplicated urinary tract infections (cystitis)  caused by Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, or Staphylococcus saprophyticus.  NOTE: In considering the use of cefpodoxime proxetil in the treatment of cystitis, cefpodoxime proxetil’s lower bacterial eradication rates should be weighed against the increased eradication rates and different safety profiles of some other classes of approved agents. (See CLINICAL STUDIESsection.)  Appropriate specimens for bacteriological examination should be obtained in order to isolate and identify causative organisms and to determine their susceptibility to cefpodoxime. Therapy may be instituted while awaiting the results of these studies. Once these results become available, antimicrobial therapy should be adjusted accordingly.  To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefpodoxime proxetil and other antibacterial drugs, cefpodoxime proxetil should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Regulatory & Marketing

Labeler Name
Redpharm Drug
Product Type
Human Prescription Drug
FDA Application #
ANDA065370
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-11-2007
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 67296-2347-1 identifies a specific commercial package of 10 tablet, film coated in 1 bottle of Cefpodoxime Proxetil, a human prescription drug labeled by Redpharm Drug. 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 Redpharm Drug on June 11, 2007. The current certification is valid through December 31, 2027.

How is this Redpharm Drug product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67296234701. 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)
67296-2347-1
11-Digit CMS (5-4-2)
67296-2347-01

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