Omeclamox-pak
NDC Package 66220-422-01

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Omeclamox-pak is a medication used to treat stomach/intestinal ulcers caused by the bacteria H. Marketed by Cumberland Pharmaceuticals Inc., this product is identified by NDC 66220-422 and is authorized under FDA application NDA050824.

Identification & Billing

NDC Package Code
66220-422-01
Package Description
1 KIT in 1 BLISTER PACK
Product Code
66220-422
11-Digit Billing Format
66220042201
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk
  • RxCUI: 1291986 - {4 (amoxicillin 500 MG Oral Capsule) / 2 (clarithromycin 500 MG Oral Tablet) / 2 (omeprazole 20 MG Delayed Release Oral Capsule) } Pack
  • RxCUI: 1291986 - amoxicillin 500 MG Oral Capsule (4) / clarithromycin 500 MG Oral Tablet (2) / omeprazole 20 MG Delayed Release Oral Capsule (2) Pack
  • RxCUI: 1291987 - {4 (amoxicillin 500 MG Oral Capsule) / 2 (clarithromycin 500 MG Oral Tablet) / 2 (omeprazole 20 MG Delayed Release Oral Capsule) } Pack [Omeclamox]
  • RxCUI: 1291987 - Omeclamox-Pak
  • RxCUI: 197517 - clarithromycin 500 MG Oral Tablet

Clinical Specifications

Proprietary Name
Omeclamox-pak
Dosage Form
-
Usage Information
This product is used to treat stomach/intestinal ulcers caused by the bacteria H. pylori and to prevent the ulcers from returning. Treating ulcers reduces the risk of serious damage to the lining of the stomach/intestines (such as bleeding, tearing, blockage). Omeprazole is known as a proton pump inhibitor (PPI). It works by blocking acid production in the stomach. Decreasing excess stomach acid can help ulcers heal. Amoxicillin and clarithromycin are antibiotics used to treat a wide variety of bacterial infections (including H. pylori). Treating the infection helps reduce the risk of ulcers returning. Amoxicillin is a penicillin-type antibiotic and clarithromycin is a macrolide-type antibiotic. They work by stopping the growth of bacteria. The antibiotics in this product treat only bacterial infections. Antibiotics do 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.

Regulatory & Marketing

Labeler Name
Cumberland Pharmaceuticals Inc.
FDA Application #
NDA050824
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-27-2012
Listing Expiration
12-31-2024
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (66220-422). Click a package code to view its specific billing and regulatory data.

66220-422-02
10 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK

* 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 66220-422-01 identifies a specific commercial package of 1 kit in 1 blister pack of Omeclamox-pak, labeled by Cumberland Pharmaceuticals Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 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 Cumberland Pharmaceuticals Inc. on April 27, 2012. The current certification is valid through December 31, 2024.

What are the primary indications for this medication?

This product is used to treat stomach/intestinal ulcers caused by the bacteria H. pylori and to prevent the ulcers from returning. Treating ulcers reduces the risk of serious damage to the lining of the stomach/intestines (such as bleeding, tearing, blockage). Omeprazole is known as a proton pump inhibitor (PPI). It works by blocking acid production in the stomach. Decreasing excess stomach acid can help ulcers heal. Amoxicillin and clarithromycin are antibiotics used to treat a wide variety of bacterial infections (including H. pylori). Treating the infection helps reduce the risk of ulcers returning. Amoxicillin is a penicillin-type antibiotic and clarithromycin is a macrolide-type antibiotic. They work by stopping the growth of bacteria. The antibiotics in this product treat only bacterial infections. Antibiotics do 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.

How is this Cumberland Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 66220042201. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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)
66220-422-01
11-Digit CMS (5-4-2)
66220-0422-01

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