Amoxicillin And Clavulanate Potassium Tablet, Coated
NDC Package 81964-221-01

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

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 influenzae and Moraxella catarrhalis.Acute Bacterial Otitis Media - caused by beta‑lactamase–producing isolates of H. This formulation utilizes a tablet, coated delivery system. Marketed by Usantibiotics, Llc, this product is identified by NDC 81964-221 and is authorized under FDA application NDA050720.

Identification & Billing

NDC Package Code
81964-221-01
Package Description
100 TABLET, COATED in 1 BOTTLE
Product Code
81964-221
11-Digit Billing Format
81964022101
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk
  • RxCUI: 562508 - amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet
  • RxCUI: 562508 - amoxicillin 875 MG / clavulanate 125 MG Oral Tablet
  • RxCUI: 562508 - amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet
  • RxCUI: 617302 - amoxicillin 125 MG / clavulanic acid 31.25 MG in 5 mL Oral Suspension
  • RxCUI: 617302 - amoxicillin 25 MG/ML / clavulanate 6.25 MG/ML Oral Suspension

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 influenzae and Moraxella catarrhalis.Acute Bacterial Otitis Media - caused by beta‑lactamase–producing isolates of H. influenzae and M. catarrhalis.Sinusitis - caused by beta‑lactamase–producing isolates of H. influenzae and M. catarrhalis.Skin and Skin Structure Infections - caused by beta‑lactamase–producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species.Urinary Tract Infections - caused by beta‑lactamase–producing isolates of E. coli, Klebsiella species, and Enterobacter species.

Regulatory & Marketing

Labeler Name
Usantibiotics, Llc
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
11-21-2022
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.

* 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 (81964-221). Click a package code to view its specific billing and regulatory data.

81964-221-14
20 TABLET, COATED 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 81964-221-01 identifies a specific commercial package of 100 tablet, coated in 1 bottle of Amoxicillin And Clavulanate Potassium, a human prescription drug labeled by Usantibiotics, Llc. 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 Usantibiotics, Llc on November 21, 2022. The current certification is valid through December 31, 2026.

How is this Usantibiotics, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 81964022101. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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)
81964-221-01
11-Digit CMS (5-4-2)
81964-0221-01

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