Cefpodoxime Proxetil Tablet, Film Coated
NDC 67296-2347

Cefpodoxime Proxetil 100 mg/1 · Tablet, Film Coated (oral)
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 67296-2347?
  4. Cefpodoxime Proxetil Uses
  5. Active Ingredients
  6. Pharmacologic Classes

Product Information

Cefpodoxime Proxetil is a ANDA-approved product labeled by Redpharm Drug. This medication is typically used as a cephalosporin antibacterial [epc]. It is supplied as a tablet, film coated for oral administration. This product entry covers the primary NDC 67296-2347 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
67296-2347
Proprietary Name:
Cefpodoxime Proxetil
Non-Proprietary Name: [1]
Cefpodoxime Proxetil
Substance Name: [2]
Cefpodoxime Proxetil
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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Clinical Specifications

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(s): [4]
Oral - Administration to or by way of the mouth.

Labeler & Regulatory Data

Labeler Name: [5]
Redpharm Drug
Labeler Code:
67296
Product Label ID:
5e42b448-9b4e-6fef-e063-6394a90aaad7
FDA Application Number: [6]
ANDA065370
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
06-11-2007
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 67296-2347?

The NDC code 67296-2347 is assigned by the FDA to the product Cefpodoxime Proxetil. This pharmaceutical product is labeled by Redpharm Drug and is currently categorized as listed product. The medication is a tablet, film coated administered via oral route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 67296-2347-1. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

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.

What are Active Ingredients of this product?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

Which are the Pharmacologic Classes of this product?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".