Omeprazole, Sodium Bicarbonate Capsule
NDC Package 53041-663-77

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Omeprazole, 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 delivery system. Marketed by Guardian Drug Company, this product is identified by NDC 53041-663 and is authorized under FDA application ANDA212587.

Identification & Billing

NDC Package Code
53041-663-77
Package Description
30 CAPSULE in 1 BOTTLE
Product Code
53041-663
11-Digit Billing Format
53041066377
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, Sodium Bicarbonate
Non-Proprietary Name
Omeprazole, Sodium Bicarbonate
Substance Name
Omeprazole; Sodium Bicarbonate
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
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 capsules used for longer than 8 weeks in patient 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 capsules may be considered.maintenance of healing of EE due to acid-mediated GERD. Controlled studies do no extend beyond 12 months

Regulatory & Marketing

Labeler Name
Guardian Drug Company
Product Type
Human Prescription Drug
FDA Application #
ANDA212587
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-07-2020
Listing Expiration
12-31-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 53041-663-77 identifies a specific commercial package of 30 capsule in 1 bottle of Omeprazole, Sodium Bicarbonate, a human prescription drug labeled by Guardian Drug Company. This capsule 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 Guardian Drug Company on May 07, 2020. The current certification is valid through December 31, 2026.

How is this Guardian Drug Company product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53041066377. 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)
53041-663-77
11-Digit CMS (5-4-2)
53041-0663-77

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