NDC Package 61919-176-15 Omeprazole Dr

View Billable Units, 11-Digit Format, RxNorm

Package Information
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Frequently Asked Questions

Package Information

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

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:

61919-176-15

Package Description:

15 CAPSULE, DELAYED RELEASE in 1 BOTTLE

Product Code:

61919-176

Proprietary Name:

Omeprazole Dr

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.

11-Digit NDC Billing Format:

61919017615

Billing Unit:

EA - Billing unit of "each" is used when the product is dispensed in discreet units.

NDC to RxNorm Crosswalk:

15 EA

NDC to 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

Labeler Name:

Direct Rx

Sample Package:

FDA Application Number:

ANDA076048

Marketing Category:

ANDA - A product marketed under an approved Abbreviated New Drug Application.

Start Marketing Date:

01-01-2015

Listing Expiration Date:

12-31-2024

Exclude Flag:

Code Structure:

61919 - Direct Rx
- 61919-176 - Omeprazole Dr
  - 61919-176-15 - 15 CAPSULE, DELAYED RELEASE in 1 BOTTLE

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 disclaimer below.

Other Product Packages

The following packages are also available for this product:

NDC Package Code	Package Description
61919-176-14	14 CAPSULE, DELAYED RELEASE in 1 BOTTLE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 61919-176-15?

The NDC Packaged Code 61919-176-15 is assigned to a package of 15 capsule, delayed release in 1 bottle of Omeprazole Dr, labeled by Direct Rx. The product's dosage form is and is administered via form.This product is billed for "EA" each discreet unit and contains an estimated amount of 15 billable units per package.

Is NDC 61919-176 included in the NDC Directory?

No, Omeprazole Dr with product code 61919-176 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Direct Rx on January 01, 2015 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 61919-176-15?

The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 15.

What is the 11-digit format for NDC 61919-176-15?

The 11-digit format is 61919017615. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	61919-176-15	5-4-2	61919-0176-15

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