Amoxicillin And Clavulanate Potassium
NDC Package 42571-395-46

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 discontinued by the firm.

Amoxicillin And Clavulanate Potassium is for oral suspension, 600 mg/42.9 mg per 5 mL is indicated for the treatment of pediatric patients withRecurrent or persistent acute otitis media due to S. Marketed by Micro Labs Limited, this product is identified by NDC 42571-395 and is authorized under FDA application ANDA217805.

Identification & Billing

NDC Package Code
42571-395-46
Package Description
75 mL in 1 BOTTLE
Product Code
42571-395
11-Digit Billing Format
42571039546

Clinical Specifications

Proprietary Name
Amoxicillin And Clavulanate Potassium
Dosage Form
-
Usage Information
Amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL 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) day care 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, 600 mg/42.9 mg per 5 mL 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, 600 mg/42.9 mg per 5 mL and other antibacterial drugs, amoxicillin and clavulanate potassium for oral suspension, 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
Micro Labs Limited
FDA Application #
ANDA217805
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-01-2024
End Marketing Date
08-04-2026
Listing Expiration
08-04-2026
Exclude Flag
D
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 (42571-395). Click a package code to view its specific billing and regulatory data.

42571-395-70
125 mL in 1 BOTTLE
42571-395-77
200 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 42571-395-46 identifies a specific commercial package of 75 ml in 1 bottle of Amoxicillin And Clavulanate Potassium, labeled by Micro Labs Limited. 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 Micro Labs Limited on April 01, 2024. The current certification is valid through August 04, 2026.

How is this Micro Labs Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42571039546. 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)
42571-395-46
11-Digit CMS (5-4-2)
42571-0395-46

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