Omeprazole Dr
NDC Package 61919-773-30

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
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 Dr is 1.1 Duodenal Ulcer (adults)Omeprazole delayed-release capsules, USP are indicated for short-term treatment of active duodenal ulcer in adults. Marketed by Direct Rx, this product is identified by NDC 61919-773 and is authorized under FDA application ANDA076048.

Identification & Billing

NDC Package Code
61919-773-30
Package Description
30 CAPSULE, DELAYED RELEASE in 1 BOTTLE
Product Code
61919-773
11-Digit Billing Format
61919077330
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
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
  • RxCUI: 200329 - omeprazole 40 MG Delayed Release Oral Capsule

Clinical Specifications

Proprietary Name
Omeprazole Dr
Dosage Form
-
Usage Information
1.1 Duodenal Ulcer (adults)Omeprazole delayed-release capsules, USP 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, USP, 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, USP, 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.)1.2 Gastric Ulcer (adults)Omeprazole delayed-release capsules, USP are indicated for short-term treatment (4 to 8 weeks) of active benign gastric ulcer in adults. [See Clinical Studies (14.2)]1.3 Treatment of Gastroesophageal Reflux Disease (GERD) (adults and pediatric patients)Symptomatic GERDOmeprazole delayed-release capsules, USP are indicated for the treatment of heartburn and other symptoms associated with GERD in pediatric patients and adults.Erosive EsophagitisOmeprazole delayed-release capsules, USP are indicated for the short-term treatment (4 to 8 weeks) of erosive esophagitis that has been diagnosed by endoscopy in pediatric patients and adults. [See Clinical Studies (14.4)]The efficacy of omeprazole delayed-release capsules, USP used for longer than 8 weeks in these patients has not been established. If a patient does not respond to 8 weeks of treatment, an additional 4 weeks of treatment may be given. If there is recurrence of erosive esophagitis or GERD symptoms (e.g., heartburn), additional 4 to 8 week courses of omeprazole may be considered.1.4 Maintenance of Healing of Erosive Esophagitis (adults)Omeprazole delayed-release capsules, USP are indicated to maintain healing of erosive esophagitis in pediatric patients and adults.Controlled studies do not extend beyond 12 months. [See Clinical Studies (14.4)]1.5 Pathological Hypersecretory ConditionsOmeprazole delayed-release capsules, USP are indicated for the long-term treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine adenomas and systemic mastocytosis) in adults.

Regulatory & Marketing

Labeler Name
Direct Rx
FDA Application #
ANDA076048
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-01-2015
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 61919-773-30 identifies a specific commercial package of 30 capsule, delayed release in 1 bottle of Omeprazole Dr, labeled by Direct Rx. This product is billed for "EA" each discreet unit and contains an estimated amount of 30 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 Direct Rx on January 01, 2015. The current certification is valid through December 31, 2024.

How is this Direct Rx product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61919077330. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 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)
61919-773-30
11-Digit CMS (5-4-2)
61919-0773-30

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