Amoxicillin Powder, For Suspension
NDC Package 72189-285-32

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

Package Information

Amoxicillin powders is amoxicillin is used to treat a wide variety of bacterial infections. This formulation utilizes a powder, for suspension delivery system. Marketed by Directrx, this product is identified by NDC 72189-285 and is authorized under FDA application ANDA065334.

Identification & Billing

NDC Package Code
72189-285-32
Package Description
100 mL in 1 BOTTLE
Product Code
72189-285
11-Digit Billing Format
72189028532
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
100 ML
RxNorm Crosswalk
  • RxCUI: 308189 - amoxicillin 400 MG in 5 mL Oral Suspension
  • RxCUI: 308189 - amoxicillin 80 MG/ML Oral Suspension
  • RxCUI: 308189 - amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral Suspension

Clinical Specifications

Proprietary Name
Amoxicillin
Non-Proprietary Name
Amoxicillin
Substance Name
Amoxicillin
Dosage Form
Powder, For Suspension - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a suspension (a liquid preparation containing the solid particles dispersed in the liquid vehicle).
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
AMOXICILLIN 400 mg/5mL
Pharmacologic Class
Usage Information
Amoxicillin is used to treat a wide variety of bacterial infections. This medication is a penicillin-type antibiotic. It works by stopping the growth of bacteria. This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections. Amoxicillin is also used with other medications to treat stomach/intestinal ulcers caused by the bacteria H. pylori and to prevent the ulcers from returning.

Regulatory & Marketing

Labeler Name
Directrx
Product Type
Human Prescription Drug
FDA Application #
ANDA065334
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-21-2021
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 72189-285-32 identifies a specific commercial package of 100 ml in 1 bottle of Amoxicillin, a human prescription drug labeled by Directrx. This product is billed per "ML" milliliter and contains an estimated amount of 100 billable units per package. This powder, for suspension is formulated for oral use and contains amoxicillin 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 Directrx on October 21, 2021. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Amoxicillin is used to treat a wide variety of bacterial infections. This medication is a penicillin-type antibiotic. It works by stopping the growth of bacteria. This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections. Amoxicillin is also used with other medications to treat stomach/intestinal ulcers caused by the bacteria H. pylori and to prevent the ulcers from returning.

How is this Directrx product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72189028532. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
72189-285-32
11-Digit CMS (5-4-2)
72189-0285-32

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