Amoxicillin And Clavulanate Potassium For Suspension
NDC Package 67296-1921-7

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Amoxicillin And Clavulanate Potassium for suspensions is amoxicillin and Clavulanate Potassium is indicated for the treatment of pediatric patients withRecurrent or persistent acute otitis media due to S. This formulation utilizes a for suspension delivery system. Marketed by Redpharm Drug, this product is identified by NDC 67296-1921 and is authorized under FDA application NDA050755.

Identification & Billing

NDC Package Code
67296-1921-7
Package Description
75 mL in 1 BOTTLE
Product Code
67296-1921
11-Digit Billing Format
67296192107

Clinical Specifications

Proprietary Name
Amoxicillin And Clavulanate Potassium
Non-Proprietary Name
Amoxicillin And Clavulanate Potassium
Substance Name
Amoxicillin; Clavulanate Potassium
Dosage Form
For Suspension - A product, usually a solid, intended for suspension prior to administration.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Amoxicillin and Clavulanate Potassium is indicated for the treatment of pediatric patients withRecurrent or persistent acute otitis media due to S. pneumoniae(penicillin MICs less than or equal to 2 mcg/mL), H. influenzae(including β-lactamase-producing strains), or M. catarrhalis(including β-lactamase-producing strains) characterized by the following risk factors:      - Antibacterial drug exposure for acute otitis media within the preceding 3 months, and either of the following: 1) age 2 years, or younger or 2) daycare attendance  [see Microbiology ( 12.4)] Limitations of UseAcute otitis media due to S. pneumoniaealone can be treated with amoxicillin. Amoxicillin and Clavulanate Potassium for oral suspension is not indicated for the treatment of acute otitis media due to S. pneumoniaewith penicillin MIC greater than or equal to 4 mcg/mL. Therapy may be instituted prior to obtaining the results from bacteriological studies when there is reason to believe the infection may involve both S. pneumoniae(penicillin MIC less than or equal to 2 mcg/mL) and the β-lactamase-producing organisms listed above. UsageTo reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin and Clavulanate Potassium for oral suspension and other antibacterial drugs, Amoxicillin and Clavulanate Potassium  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
Redpharm Drug
Product Type
Human Prescription Drug
FDA Application #
NDA050755
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
09-19-2022
Listing Expiration
12-31-2026
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.

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Frequently Asked Questions

What is the distribution configuration for this product package?

The code 67296-1921-7 identifies a specific commercial package of 75 ml in 1 bottle of Amoxicillin And Clavulanate Potassium, a human prescription drug labeled by Redpharm Drug. This for suspension is formulated for oral use and contains amoxicillin; clavulanate potassium 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 September 19, 2022. The current certification is valid through December 31, 2026.

How is this Redpharm Drug product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67296192107. 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)
67296-1921-7
11-Digit CMS (5-4-2)
67296-1921-07

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