Amoxicillin Capsule
NDC Package 76420-545-50

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

Package Information

Amoxicillin capsules is amoxicillin is used to treat a wide variety of bacterial infections. This formulation utilizes a capsule delivery system. Marketed by Asclemed Usa, Inc., this product is identified by NDC 76420-545 and is authorized under FDA application ANDA061926.

Identification & Billing

NDC Package Code
76420-545-50
Package Description
50 CAPSULE in 1 BOTTLE
Product Code
76420-545
11-Digit Billing Format
76420054550
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
50 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Amoxicillin
Non-Proprietary Name
Amoxicillin
Substance Name
Amoxicillin
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
AMOXICILLIN 500 mg/1
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
Asclemed Usa, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA061926
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-30-1990
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 76420-545-50 identifies a specific commercial package of 50 capsule in 1 bottle of Amoxicillin, a human prescription drug labeled by Asclemed Usa, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 50 billable units per package. This capsule 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 Asclemed Usa, Inc. on September 30, 1990. 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 Asclemed Usa, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76420054550. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 50 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)
76420-545-50
11-Digit CMS (5-4-2)
76420-0545-50

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