Amoxicillin Capsule
NDC Package 65862-017-30

11-digit billing NDC: 65862001730
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Amoxicillin capsules is adults and Pediatric PatientsUpper Respiratory Tract Infections of the Ear, Nose, and Throat:  Amoxicillin capsules  are indicated in the treatment of infections due to susceptible (ONLY β- lactamase–negative) isolates of Streptococcus species. This formulation utilizes a capsule delivery system. Marketed by Aurobindo Pharma Limited, this product is identified by NDC 65862-017 and is authorized under FDA application ANDA065271.

Identification & Billing

NDC Package Code
65862-017-30
Package Description
30 CAPSULE in 1 BOTTLE
Product Code
65862-017
11-Digit Billing Format
65862001730
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)
Pharmacologic Class
Usage Information
Adults and Pediatric PatientsUpper Respiratory Tract Infections of the Ear, Nose, and Throat:  Amoxicillin capsules  are indicated in the treatment of infections due to susceptible (ONLY β- lactamase–negative) isolates of Streptococcus species. (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae.Infections of the Genitourinary Tract: 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 capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), Staphylococcus spp., or E. coli.Infections of the Lower Respiratory Tract: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H. influenzae.Adult Patients onlyHelicobacter pylori Infection and Duodenal Ulcer Disease: Triple therapy for Helicobacter pylori (H. pylori) with clarithromycin and lansoprazole: Amoxicillin capsules in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.Dual therapy for H. pylori with lansoprazole: Amoxicillin capsules, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with H. pylori infection 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. pylori has been shown to reduce the risk of duodenal ulcer recurrence.Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin capsules and other antibacterial drugs, amoxicillin capsules 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
Aurobindo Pharma Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA065271
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-09-2005
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (65862-017). Click a package code to view its specific billing and regulatory data.

65862-017-01
100 CAPSULE in 1 BOTTLE
65862-017-05
500 CAPSULE in 1 BOTTLE
65862-017-15
1500 CAPSULE in 1 BAG
65862-017-20
20 CAPSULE in 1 BOTTLE
65862-017-50
50 CAPSULE in 1 BOTTLE
65862-017-99
1000 CAPSULE in 1 BAG

* 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 65862-017-30 identifies a specific commercial package of 30 capsule in 1 bottle of Amoxicillin, a human prescription drug labeled by Aurobindo Pharma Limited. 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 Aurobindo Pharma Limited on November 09, 2005. The current certification is valid through December 31, 2026.

How is this Aurobindo Pharma Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65862001730. 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)
65862-017-30
11-Digit CMS (5-4-2)
65862-0017-30

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