Omeclamox-pak
NDC 66220-422

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 66220-422?
  5. Omeclamox-pak Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Patient Education

Product Information

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

Omeclamox-pak is a NDA-approved product labeled by Cumberland Pharmaceuticals Inc.. This product is used to treat stomach/intestinal ulcers caused by the bacteria H. It is supplied as a gray product. This product entry covers the primary NDC 66220-422 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
66220-422
Proprietary Name:
Omeclamox-pak
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
Cumberland Pharmaceuticals Inc.
Labeler Code:
66220
Product Label ID:
9e52c29a-fdbe-4a4d-b280-d700eba5b94f
FDA Application Number: [6]
NDA050824
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
04-27-2012
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
I

Product Characteristics

Color(s):
GRAY (C48324 - LAVENDAR AND GRAY)
WHITE (C48325)
ORANGE (C48331 - PEACH AND ORANGE)
Shape:
CAPSULE (C48336)
OVAL (C48345)
Size(s):
18 MM
19 MM
22 MM
Imprint(s):
R;158;OMEPRAZOL;20;MG
54;312
WC;731
Score:
1

Code Structure Chart

Product Details

What is NDC 66220-422?

The NDC code 66220-422 is assigned by the FDA to the product Omeclamox-pak. This pharmaceutical product is labeled by Cumberland Pharmaceuticals Inc. and is currently categorized as listed product. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 66220-422-01, 66220-422-02. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

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.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for this product?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • 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

* Please review the full disclaimer at the bottom of this page.

Patient Education

Amoxicillin


Amoxicillin is used to treat certain infections caused by bacteria, such as pneumonia; bronchitis (infection of the airway tubes leading to the lungs); and infections of the ears, nose, throat, urinary tract, and skin. It is also used in combination with other medications to eliminate H. pylori, a bacteria that causes ulcers. Amoxicillin is in a class of medications called penicillin-like antibiotics. It works by stopping the growth of bacteria. Antibiotics such as amoxicillin will not work for colds, flu, and other viral infections. Taking antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.
[Learn More]


Clarithromycin


Clarithromycin is used to treat certain bacterial infections, such as pneumonia (a lung infection), bronchitis (infection of the tubes leading to the lungs), and infections of the ears, sinuses, skin, and throat. It also is used to treat and prevent disseminated Mycobacterium avium complex (MAC) infection [a type of lung infection that often affects people with human immunodeficiency virus (HIV)]. It is used in combination with other medications to eliminate H. pylori, a bacterium that causes ulcers. Clarithromycin is in a class of medications called macrolide antibiotics. It works by stopping the growth of bacteria. Antibiotics such as clarithromycin will not work for colds, flu, or other viral infections. Taking antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.
[Learn More]


Lansoprazole, Clarithromycin, and Amoxicillin


Lansoprazole, clarithromycin, and amoxicillin are used to treat and prevent the return of ulcers (sores in the lining of the stomach or intestine) caused by a certain type of bacteria (H. pylori). Lansoprazole is in a class of medications called proton pump inhibitors. Clarithromycin and amoxicillin are in a class of medications called antibiotics. Lansoprazole works by decreasing the amount of acid made in the stomach. Clarithromycin and amoxicillin work by stopping the growth of the bacteria that may cause ulcers. Antibiotics will not work for colds, flu, or other viral infections.
[Learn More]


Omeprazole


Prescription omeprazole is used alone or with other medications to treat the symptoms of gastroesophageal reflux disease (GERD), a condition in which backward flow of acid from the stomach causes heartburn and possible injury of the esophagus (the tube between the throat and stomach) in adults and children 1 year of age and older. Prescription omeprazole is used to treat damage from GERD in adults and children 1 month of age and older. Prescription omeprazole is used to allow the esophagus to heal and prevent further damage to the esophagus in adults and children 1 year of age and older with GERD. Prescription omeprazole is also used to treat conditions in which the stomach produces too much acid such as Zollinger-Ellison syndrome in adults. Prescription omeprazole is also used to treat ulcers (sores in the lining of the stomach or intestine) and it is also used with other medications to treat and prevent the return of ulcers caused by a certain type of bacteria (H. pylori) in adults. Nonprescription (over-the-counter) omeprazole is used to treat frequent heartburn (heartburn that occurs at least 2 or more days a week) in adults. Omeprazole is in a class of medications called proton-pump inhibitors. It works by decreasing the amount of acid made in the stomach.
[Learn More]


* Please review the full disclaimer at the bottom of this page.

Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".