Amoxicillin Tablet, Film Coated
NDC Package 67046-0015-3

11-digit billing NDC: 67046001503
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Amoxicillin tablets is adults and Pediatric PatientsUpper Respiratory Tract Infections of the Ear, Nose, and Throat:Amoxicillin tablets are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcusspecies. This formulation utilizes a tablet, film coated delivery system. Marketed by Coupler Llc, this product is identified by NDC 67046-0015 and is authorized under FDA application ANDA065256.

Identification & Billing

NDC Package Code
67046-0015-3
Package Description
30 TABLET, FILM COATED in 1 BLISTER PACK
Product Code
67046-0015
11-Digit Billing Format
67046001503
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Amoxicillin
Non-Proprietary Name
Amoxicillin
Substance Name
Amoxicillin
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
AMOXICILLIN 875 mg/1
Pharmacologic Class
Usage Information
Adults and Pediatric PatientsUpper Respiratory Tract Infections of the Ear, Nose, and Throat:Amoxicillin tablets are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcusspecies. (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcusspp., or Haemophilus influenzae. Infections of the Genitourinary Tract:Amoxicillin tablets are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Escherichia coli, Proteus mirabilis, or Enterococcus faecalis.  Infections of the Skin and Skin Structure:Amoxicillin tablets are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcusspp. (α- and β-hemolytic isolates only), Staphylococcusspp., or E. coli. Infections of the Lower Respiratory Tract:Amoxicillin tablets are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcusspp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcusspp., or H. influenzae.  Adult Patients onlyHelicobacter pyloriInfection and Duodenal Ulcer Disease:Triple therapy for Helicobacter pylori (H. pylori)with clarithromycin and lansoprazole:   Amoxicillin tablets, in combination with clarithromycin plus lansoprazole as triple therapy, are indicated for the treatment of patients with H. pyloriinfection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylorihas been shown to reduce the risk of duodenal ulcer recurrence. Dual therapy for H. pyloriwith lansoprazole :  Amoxicillin tablets, in combination with lansoprazole delayed-release capsules as dual therapy, are indicated for the treatment of patients with H. pyloriinfection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. (See the clarithromycin package insert, MICROBIOLOGY.) Eradication of H. pylorihas been shown to reduce the risk of duodenal ulcer recurrence. UsageTo reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin tablets and other antibacterial drugs, amoxicillin tablets should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Regulatory & Marketing

Labeler Name
Coupler Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA065256
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-24-2026
Listing Expiration
12-31-2027
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 67046-0015-3 identifies a specific commercial package of 30 tablet, film coated in 1 blister pack of Amoxicillin, a human prescription drug labeled by Coupler Llc. This tablet, film coated 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 Coupler Llc on April 24, 2026. The current certification is valid through December 31, 2027.

How is this Coupler Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67046001503. 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 (5-4-1)
67046-0015-3
11-Digit CMS (5-4-2)
67046-0015-03

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