Amoxicillin And Clavulanate Potassium Tablet, Coated
NDC Package 70518-4758-0

11-digit billing NDC: 70518475800
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Amoxicillin And Clavulanate Potassium tablets is amoxicillin and Clavulanate Potassium is indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below:Lower Respiratory Tract Infections- caused by beta‑lactamase–producing isolates of Haemophilus influenzaeand Moraxella catarrhalis. This formulation utilizes a tablet, coated delivery system. Marketed by Remedyrepack Inc., this product is identified by NDC 70518-4758 and is authorized under FDA application NDA050720.

Identification & Billing

NDC Package Code
70518-4758-0
Package Description
100 POUCH in 1 BOX / 1 TABLET, COATED in 1 POUCH (70518-4758-1)
Product Code
70518-4758
11-Digit Billing Format
70518475800

Clinical Specifications

Proprietary Name
Amoxicillin And Clavulanate Potassium
Non-Proprietary Name
Amoxicillin And Clavulanate Potassium
Substance Name
Amoxicillin; Clavulanate Potassium
Dosage Form
Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.
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 infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below:Lower Respiratory Tract Infections- caused by beta‑lactamase–producing isolates of Haemophilus influenzaeand Moraxella catarrhalis. Acute Bacterial Otitis Media- caused by beta‑lactamase–producing isolates of H. influenzaeand M. catarrhalis. Sinusitis- caused by beta‑lactamase–producing isolates of H. influenzaeand M. catarrhalis. Skin and Skin Structure Infections- caused by beta‑lactamase–producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiellaspecies. Urinary Tract Infections- caused by beta‑lactamase–producing isolates of E. coli, Klebsiellaspecies, and Enterobacterspecies.

Regulatory & Marketing

Labeler Name
Remedyrepack Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA050720
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
09-21-2026
Listing Expiration
12-31-2027
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.

* 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 70518-4758-0 identifies a specific commercial package of 100 pouch in 1 box / 1 tablet, coated in 1 pouch (70518-4758-1) of Amoxicillin And Clavulanate Potassium, a human prescription drug labeled by Remedyrepack Inc.. This tablet, coated 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 Remedyrepack Inc. on September 21, 2026. The current certification is valid through December 31, 2027.

How is this Remedyrepack Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70518475800. 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)
70518-4758-0
11-Digit CMS (5-4-2)
70518-4758-00

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