Omeprazole
NDC Package 69181-158-14

11-digit billing NDC: 69181015814
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.

Omeprazole is delayed-release capsules are indicated for short-term treatment of active duodenal ulcer in adults. Marketed by Midwest Drug Distribution, Inc., this product is identified by NDC 69181-158 and is authorized under FDA application ANDA075576.

Identification & Billing

NDC Package Code
69181-158-14
Package Description
14 CAPSULE, DELAYED RELEASE in 1 PACKAGE
Product Code
69181-158
11-Digit Billing Format
69181015814
RxNorm Crosswalk
  • RxCUI: 198051 - omeprazole 20 MG Delayed Release Oral Capsule
  • RxCUI: 198051 - omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule

Clinical Specifications

Proprietary Name
Omeprazole
Dosage Form
-
Usage Information
Omeprazole delayed-release capsules are indicated for short-term treatment of active duodenal ulcer in adults. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy. Omeprazole delayed-release capsules, in combination with clarithromycin and amoxicillin, are indicated for treatment of patients with H. pylori infection and duodenal ulcer disease (active or up to 1-year history) to eradicate H. pylori in adults.Omeprazole delayed-release capsules, in combination with clarithromycin are indicated for treatment of patients with H. pylori infection and duodenal ulcer disease to eradicate H. pylori in adults.Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see Clinical Studies (14.1) and Dosage and Administration(2)].Among patients who fail therapy, Omeprazole delayed-release capsules with clarithromycin are more likely to be associated with the development of clarithromycin resistance as compared with triple therapy. In patients who fail therapy, susceptibility testing should be done. If resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted. [See Microbiology section (12.4)], and the clarithromycin package insert, Microbiology section.)

Regulatory & Marketing

Labeler Name
Midwest Drug Distribution, Inc.
FDA Application #
ANDA075576
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-04-2015
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 69181-158-14 identifies a specific commercial package of 14 capsule, delayed release in 1 package of Omeprazole, labeled by Midwest Drug Distribution, 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 Midwest Drug Distribution, Inc. on February 04, 2015. The current certification is valid through December 31, 2019.

How is this Midwest Drug Distribution, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69181015814. 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)
69181-158-14
11-Digit CMS (5-4-2)
69181-0158-14

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