Amoxicillin And Clavulanate Potassium
NDC Package 63304-768-07

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.

Amoxicillin And Clavulanate Potassium is for oral suspension, USP, 600 mg/42.9 mg per 5 mL is indicated for the treatment of pediatric patients with recurrent or persistent acute otitis media due to S. Marketed by Ranbaxy Pharmaceuticals Inc., this product is identified by NDC 63304-768 and is authorized under FDA application ANDA065207.

Identification & Billing

NDC Package Code
63304-768-07
Package Description
125 mL in 1 BOTTLE
Product Code
63304-768
11-Digit Billing Format
63304076807
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
125 ML
RxNorm Crosswalk
  • RxCUI: 617993 - amoxicillin 600 MG / clavulanic acid 42.9 MG in 5 mL Oral Suspension
  • RxCUI: 617993 - amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral Suspension
  • RxCUI: 617993 - amoxicillin (as amoxicillin trihydrate) 600 MG / clavulanic acid (as clavulanate potassium) 42.9 MG per 5 ML Oral Suspension
  • RxCUI: 617993 - amoxicillin 600 MG / clavulanic acid 42.9 MG per 5 ML Oral Suspension

Clinical Specifications

Proprietary Name
Amoxicillin And Clavulanate Potassium
Dosage Form
-
Usage Information
Amoxicillin and clavulanate potassium for oral suspension, USP, 600 mg/42.9 mg per 5 mL is indicated for the treatment of pediatric patients with recurrent or persistent acute otitis media due to S. pneumoniae (penicillin MICs ≤ 2mcg/mL), H. influenzae (including β-lactamase-producing strains), or M. catarrhalis (including b-lactamase-producing strains) characterized by the following risk factors:antibiotic exposure for acute otitis media within the preceding 3 months, and either of the following:age ≤ 2 yearsdaycare attendance[See CLINICAL PHARMACOLOGY, Microbiology].NOTE: Acute otitis media due to S. pneumoniae alone can be treated with amoxicillin. Amoxicillin and clavulanate potassium for oral suspension, USP, 600 mg/42.9 mg per 5 mL is not indicated for the treatment of acute otitis media due to S. pneumoniae with penicillin MIC ≥ 4 mcg/mL.Therapy may be instituted prior to obtaining results from bacteriological studies when there is reason to believe the infection may involve both S. pneumoniae (penicillin MIC ≤ 2 mcg/mL) and the b-lactamase-producing organisms that listed above.To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium for oral suspension, USP, 600 mg/42.9 mg per 5 mL and other antibacterial drugs, amoxicillin and clavulanate potassium for oral suspension, USP, 600 mg/42.9 mg per 5 mL 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 #
ANDA065207
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-13-2007
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 (63304-768). Click a package code to view its specific billing and regulatory data.

63304-768-01
75 mL in 1 BOTTLE
63304-768-02
200 mL in 1 BOTTLE
63304-768-03
50 mL in 1 BOTTLE
63304-768-04
100 mL in 1 BOTTLE
63304-768-50
150 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 63304-768-07 identifies a specific commercial package of 125 ml in 1 bottle of Amoxicillin And Clavulanate Potassium, labeled by Ranbaxy Pharmaceuticals Inc.. This product is billed per "ML" milliliter and contains an estimated amount of 125 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 March 13, 2007. 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: 63304076807. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 125 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)
63304-768-07
11-Digit CMS (5-4-2)
63304-0768-07

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