Cefuroxime Axetil For Oral Suspension
NDC Package 63304-964-03

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

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Cefuroxime Axetil For Oral Suspension is nOTE: CEFUROXIME AXETIL TABLETS AND CEFUROXIME AXETIL FOR ORAL SUSPENSION ARE NOT BIOEQUIVALENT AND ARE NOT SUBSTITUTABLE ON AMILLIGRAM-PER-MILLIGRAM BASIS (SEE CLINICAL PHARMACOLOGY).Cefuroxime axetil for oral suspension is indicated for the treatment of pediatric patients 3 months to 12 years of age with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below. Marketed by Ranbaxy Pharmaceuticals Inc, this product is identified by NDC 63304-964 and is authorized under FDA application ANDA065323.

Identification & Billing

NDC Package Code
63304-964-03
Package Description
50 mL in 1 BOTTLE
Product Code
63304-964
11-Digit Billing Format
63304096403
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
50 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cefuroxime Axetil For Oral Suspension
Dosage Form
-
Usage Information
NOTE: CEFUROXIME AXETIL TABLETS AND CEFUROXIME AXETIL FOR ORAL SUSPENSION ARE NOT BIOEQUIVALENT AND ARE NOT SUBSTITUTABLE ON AMILLIGRAM-PER-MILLIGRAM BASIS (SEE CLINICAL PHARMACOLOGY).Cefuroxime axetil for oral suspension is indicated for the treatment of pediatric patients 3 months to 12 years of age with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below. The safety and effectiveness of cefuroxime axetil for oral suspension in the treatment of infections other than those specifically listed below have not been established either by adequate and well-controlled trials or by pharmacokinetic data with which to determine an effective and safe dosing regimen.Pharyngitis/Tonsillitis caused by Streptococcus pyogenes. NOTE: The usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever, is penicillin given by the intramuscular route. Cefuroxime axetil for oral suspension is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cefuroxime in the subsequent prevention of rheumatic fever are not available. Please also note that in all clinical trials, all isolates had to be sensitive to both penicillin and cefuroxime. There are no data from adequate and well-controlled trials to demonstrate the effectiveness of cefuroxime in the treatment of penicillin-resistant strains of Streptococcus pyogenes.Acute Bacterial Otitis Media caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta-lactamase-producing strains), Moraxella catarrhalis (including beta-lactamase-producing strains), or Streptococcus pyogenes.Impetigo caused by Staphylococcus aureus (including beta-lactamase-producing strains) or Streptococcus pyogenes.To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefuroxime axetil for oral suspension and other antibacterial drugs, cefuroxime axetil for oral suspension 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
Ranbaxy Pharmaceuticals Inc
FDA Application #
ANDA065323
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-08-2008
Listing Expiration
12-31-2017
Exclude Flag
I
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 (63304-964). Click a package code to view its specific billing and regulatory data.

63304-964-04
100 mL 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 63304-964-03 identifies a specific commercial package of 50 ml in 1 bottle of Cefuroxime Axetil For Oral Suspension, labeled by Ranbaxy Pharmaceuticals Inc. This product is billed per "ML" milliliter and contains an estimated amount of 50 billable units per package. 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 Ranbaxy Pharmaceuticals Inc on February 08, 2008. The current certification is valid through December 31, 2017.

How is this Ranbaxy Pharmaceuticals Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63304096403. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 50 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)
63304-964-03
11-Digit CMS (5-4-2)
63304-0964-03

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