Omeprazole
NDC Package 11383-257-43

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.

Omeprazole is used to treat certain stomach and esophagus problems (such as acid reflux, ulcers). Marketed by Weeks & Leo Co., Inc., this product is identified by NDC 11383-257 and is authorized under FDA application NDA022032.

Identification & Billing

NDC Package Code
11383-257-43
Package Description
3 BLISTER PACK in 1 CARTON / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK
Product Code
11383-257
11-Digit Billing Format
11383025743
RxNorm Crosswalk
  • RxCUI: 402014 - omeprazole 20 MG Delayed Release Oral Tablet
  • RxCUI: 402014 - omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Tablet

Clinical Specifications

Proprietary Name
Omeprazole Delayed Release
Dosage Form
-
Usage Information
Omeprazole is used to treat certain stomach and esophagus problems (such as acid reflux, ulcers). It works by decreasing the amount of acid your stomach makes. It relieves symptoms such as heartburn, difficulty swallowing, and persistent cough. This medication helps heal acid damage to the stomach and esophagus, helps prevent ulcers, and may help prevent cancer of the esophagus. Omeprazole belongs to a class of drugs known as proton pump inhibitors (PPIs). If you are self-treating with this medication, over-the-counter omeprazole products are used to treat frequent heartburn (occurring 2 or more days a week). Since it may take 1 to 4 days to have full effect, these products do not relieve heartburn right away. For over-the-counter products, carefully read the package instructions to make sure the product is right for you. Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar brand names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.

Regulatory & Marketing

Labeler Name
Weeks & Leo Co., Inc.
FDA Application #
NDA022032
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-12-2011
Listing Expiration
12-31-2018
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 (11383-257). Click a package code to view its specific billing and regulatory data.

11383-257-16
1 BLISTER PACK in 1 CARTON / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK
11383-257-61
2 BLISTER PACK in 1 CARTON / 14 TABLET, DELAYED RELEASE 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 11383-257-43 identifies a specific commercial package of 3 blister pack in 1 carton / 14 tablet, delayed release in 1 blister pack of Omeprazole Delayed Release, labeled by Weeks & Leo Co., Inc.. 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 Weeks & Leo Co., Inc. on July 12, 2011. The current certification is valid through December 31, 2018.

What are the primary indications for this medication?

Omeprazole is used to treat certain stomach and esophagus problems (such as acid reflux, ulcers). It works by decreasing the amount of acid your stomach makes. It relieves symptoms such as heartburn, difficulty swallowing, and persistent cough. This medication helps heal acid damage to the stomach and esophagus, helps prevent ulcers, and may help prevent cancer of the esophagus. Omeprazole belongs to a class of drugs known as proton pump inhibitors (PPIs). If you are self-treating with this medication, over-the-counter omeprazole products are used to treat frequent heartburn (occurring 2 or more days a week). Since it may take 1 to 4 days to have full effect, these products do not relieve heartburn right away. For over-the-counter products, carefully read the package instructions to make sure the product is right for you. Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar brand names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.

How is this Weeks & Leo Co., Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 11383025743. 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)
11383-257-43
11-Digit CMS (5-4-2)
11383-0257-43

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