NDC Package 63304-963-03 Cefuroxime Axetil For Oral Suspension

View Billable Units, 11-Digit Format, RxNorm

Package Information
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Frequently Asked Questions

Package Information

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

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:

63304-963-03

Package Description:

50 mL in 1 BOTTLE

Product Code:

63304-963

Proprietary Name:

Cefuroxime Axetil For Oral Suspension

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.

11-Digit NDC Billing Format:

63304096303

NDC to RxNorm Crosswalk:

RxCUI: 309096 - cefuroxime axetil 125 MG in 5 mL Oral Suspension

RxCUI: 309096 - cefuroxime 25 MG/ML Oral Suspension

RxCUI: 309096 - cefuroxime axetil 125 MG per 5 ML Oral Suspension

Labeler Name:

Ranbaxy Pharmaceuticals Inc

Sample Package:

Start Marketing Date:

02-08-2008

Listing Expiration Date:

12-31-2017

Exclude Flag:

Code Structure:

63304 - Ranbaxy Pharmaceuticals Inc
- 63304-963 - Cefuroxime Axetil For Oral Suspension
  - 63304-963-03 - 50 mL in 1 BOTTLE

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 disclaimer below.

Other Product Packages

The following packages are also available for this product:

NDC Package Code	Package Description
63304-963-04	100 mL in 1 BOTTLE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 63304-963-03?

The NDC Packaged Code 63304-963-03 is assigned to a package of 50 ml in 1 bottle of Cefuroxime Axetil For Oral Suspension, labeled by Ranbaxy Pharmaceuticals Inc. The product's dosage form is and is administered via form.

Is NDC 63304-963 included in the NDC Directory?

No, Cefuroxime Axetil For Oral Suspension with product code 63304-963 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Ranbaxy Pharmaceuticals Inc on February 08, 2008 and its listing in the NDC Directory is set to expire on December 31, 2017 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 63304-963-03?

The 11-digit format is 63304096303. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	63304-963-03	5-4-2	63304-0963-03

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