Amoxicillin Capsule
NDC Package 82868-088-30

11-digit billing NDC: 82868008830
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Amoxicillin capsules is adults and Pediatric PatientsUpper Respiratory Tract Infections of the Ear, Nose, and Throat:Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcusspecies. This formulation utilizes a capsule delivery system. Marketed by Northwind Health Company, Llc, this product is identified by NDC 82868-088 and is authorized under FDA application ANDA061926.

Identification & Billing

NDC Package Code
82868-088-30
Package Description
30 CAPSULE in 1 BOTTLE, PLASTIC
Product Code
82868-088
11-Digit Billing Format
82868008830

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 250 mg/1
Pharmacologic Class
Usage Information
Adults and Pediatric PatientsUpper Respiratory Tract Infections of the Ear, Nose, and Throat:Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules 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, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules 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, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules 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, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules 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, in combination with clarithromycin plus lansoprazole as triple therapy, is 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, in combination with lansoprazole delayed-release capsules as dual therapy, is 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 and other antibacterial drugs, amoxicillin 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
Northwind Health Company, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA061926
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-15-2026
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 82868-088-30 identifies a specific commercial package of 30 capsule in 1 bottle, plastic of Amoxicillin, a human prescription drug labeled by Northwind Health Company, Llc. 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 Northwind Health Company, Llc on September 15, 2026. The current certification is valid through December 31, 2027.

How is this Northwind Health Company, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 82868008830. 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)
82868-088-30
11-Digit CMS (5-4-2)
82868-0088-30

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