Amoxicillin And Clavulanate Potassium For Suspension
NDC Package 81964-212-01

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 for suspensions 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 for suspension delivery system. Marketed by Usantibiotics, Llc, this product is identified by NDC 81964-212 and is authorized under FDA application NDA050575.

Identification & Billing

NDC Package Code
81964-212-01
Package Description
75 mL in 1 BOTTLE
Product Code
81964-212
11-Digit Billing Format
81964021201
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
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 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 #
NDA050575
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
12-05-2022
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 (81964-212). Click a package code to view its specific billing and regulatory data.

81964-212-03
100 mL in 1 BOTTLE
81964-212-05
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 81964-212-01 identifies a specific commercial package of 75 ml in 1 bottle of Amoxicillin And Clavulanate Potassium, a human prescription drug labeled by Usantibiotics, Llc. 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 Usantibiotics, Llc on December 05, 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: 81964021201. 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)
81964-212-01
11-Digit CMS (5-4-2)
81964-0212-01

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