Amoxicillin
NDC Package 33261-602-01

11-digit billing NDC: 33261060201 · Billing unit: ML · 150 ML per package
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 inactivated by the FDA.

Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) strains of the designated microorganisms in the conditions listed below:Infections of the ear, nose, and throat – due to Streptococcus spp. Marketed by Aidarex Pharmaceuticals Llc, this product is identified by NDC 33261-602 and is authorized under FDA application ANDA065322.

Identification & Billing

NDC Package Code
33261-602-01
Package Description
150 mL in 1 BOTTLE, PLASTIC
Product Code
33261-602
11-Digit Billing Format
33261060201
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
150 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Amoxicillin
Dosage Form
-
Usage Information
Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) strains of the designated microorganisms in the conditions listed below:Infections of the ear, nose, and throat – due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae.Infections of the genitourinary tract – due to E. coli, P. mirabilis, or E. faecalis.Infections of the skin and skin structure – due to Streptococcus spp. (α- and β-hemolytic strains only), Staphylococcus spp., or E. coli.Infections of the lower respiratory tract – due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae,Staphylococcus spp., or H. influenzae.Gonorrhea, acute uncomplicated (ano-genital and urethral infections) – due to N. gonorrhoeae (males and females).H. pylori eradication to reduce the risk of duodenal ulcer recurrence

Regulatory & Marketing

Labeler Name
Aidarex Pharmaceuticals Llc
FDA Application #
ANDA065322
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-19-2006
Listing Expiration
12-31-2019
Exclude Flag
I
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 33261-602-01 identifies a specific commercial package of 150 ml in 1 bottle, plastic of Amoxicillin, labeled by Aidarex Pharmaceuticals Llc. This product is billed per "ML" milliliter and contains an estimated amount of 150 billable units per package. 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 Aidarex Pharmaceuticals Llc on June 19, 2006. The current certification is valid through December 31, 2019.

How is this Aidarex Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 33261060201. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 150 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)
33261-602-01
11-Digit CMS (5-4-2)
33261-0602-01

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