Amoxicillin
NDC Package 0143-9821-01

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Amoxicillin is used to treat a wide variety of bacterial infections. Marketed by Hikma Pharmaceuticals Usa Inc., this product is identified by NDC 0143-9821 and is authorized under FDA application ANDA205274.

Identification & Billing

NDC Package Code
0143-9821-01
Package Description
100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC
Product Code
0143-9821
11-Digit Billing Format
00143982101

Clinical Specifications

Proprietary Name
Amoxicillin
Dosage Form
-
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
Hikma Pharmaceuticals Usa Inc.
FDA Application #
ANDA205274
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-31-2021
End Marketing Date
07-31-2021
Listing Expiration
07-31-2021
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0143-9821-01 identifies a specific commercial package of 100 tablet, chewable in 1 bottle, plastic of Amoxicillin, labeled by Hikma Pharmaceuticals Usa Inc.. 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 Hikma Pharmaceuticals Usa Inc. on July 31, 2021. The current certification is valid through July 31, 2021.

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 Hikma Pharmaceuticals Usa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00143982101. 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 (4-4-2)
0143-9821-01
11-Digit CMS (5-4-2)
00143-9821-01

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