Omeprazole/bicarbonate Capsule, Gelatin Coated
NDC Package 69367-196-05

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

Omeprazole/bicarbonate (omeprazole and sodium bicarbonate) capsules is omeprazole and sodium bicarbonate capsules are indicated in adults for the:short-term treatment of active duodenal ulcer. This formulation utilizes a capsule, gelatin coated delivery system. Marketed by Westminster Pharmaceuticals, Llc, this product is identified by NDC 69367-196 and is authorized under FDA application ANDA207476.

Identification & Billing

NDC Package Code
69367-196-05
Package Description
30 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC
Product Code
69367-196
11-Digit Billing Format
69367019605
RxNorm Crosswalk
  • RxCUI: 616539 - omeprazole 20 MG / sodium bicarbonate 1100 MG Oral Capsule
  • RxCUI: 616539 - Omeprazole 20 MG / NaHCO3 1100 MG Oral Capsule
  • RxCUI: 616541 - omeprazole 40 MG / sodium bicarbonate 1100 MG Oral Capsule
  • RxCUI: 616541 - Omeprazole 40 MG / NaHCO3 1100 MG Oral Capsule

Clinical Specifications

Proprietary Name
Omeprazole/bicarbonate
Non-Proprietary Name
Omeprazole And Sodium Bicarbonate
Substance Name
Omeprazole; Sodium Bicarbonate
Dosage Form
Capsule, Gelatin Coated - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin; through a banding process, the capsule is coated with additional layers of gelatin so as to form a complete seal.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Omeprazole and sodium bicarbonate capsules are indicated in adults for the:short-term treatment of active duodenal ulcer. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.short-term treatment (4 to 8 weeks) of active benign gastric ulcer.treatment of heartburn and other symptoms associated with GERD for up to 4 weeks.short-term treatment (4 to 8 weeks) of EE due to acid-mediated GERD which has been diagnosed by endoscopy in adults.The efficacy of omeprazole and sodium bicarbonate used for longer than 8 weeks in patients with EE 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 EE or GERD symptoms (e.g., heartburn), additional 4 to 8-week courses of omeprazole and sodium bicarbonate may be considered.maintenance of healing of EE due to acid-mediated GERD. Controlled studies do not extend beyond 12 months.

Regulatory & Marketing

Labeler Name
Westminster Pharmaceuticals, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA207476
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-27-2018
Listing Expiration
12-31-2027
Exclude Flag
N
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 (69367-196). Click a package code to view its specific billing and regulatory data.

69367-196-30
30 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC

* 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 69367-196-05 identifies a specific commercial package of 30 capsule, gelatin coated in 1 bottle, plastic of Omeprazole/bicarbonate, a human prescription drug labeled by Westminster Pharmaceuticals, Llc. This capsule, gelatin coated is formulated for oral use and contains omeprazole; sodium bicarbonate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Westminster Pharmaceuticals, Llc on July 27, 2018. The current certification is valid through December 31, 2027.

How is this Westminster Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69367019605. 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)
69367-196-05
11-Digit CMS (5-4-2)
69367-0196-05

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