Omeprazole Capsule
NDC Package 79481-0061-3

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

Package Information

Omeprazole capsules is omeprazole is used to treat certain stomach and esophagus problems (such as acid reflux, ulcers). This formulation utilizes a capsule delivery system. Marketed by Meijer Distribution Inc., this product is identified by NDC 79481-0061 and is authorized under FDA application ANDA210593.

Identification & Billing

NDC Package Code
79481-0061-3
Package Description
3 BOTTLE in 1 CARTON / 14 CAPSULE in 1 BOTTLE (79481-0061-1)
Product Code
79481-0061
11-Digit Billing Format
79481006103
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
Non-Proprietary Name
Omeprazole
Substance Name
Omeprazole Magnesium
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)
OMEPRAZOLE MAGNESIUM 20.6 mg/1
Pharmacologic Class
Usage Information
Omeprazole is used to treat certain stomach and esophagus problems (such as acid reflux, ulcers). It works by decreasing the amount of acid your stomach makes. It relieves symptoms such as heartburn, difficulty swallowing, and persistent cough. This medication helps heal acid damage to the stomach and esophagus, helps prevent ulcers, and may help prevent cancer of the esophagus. Omeprazole belongs to a class of drugs known as proton pump inhibitors (PPIs). If you are self-treating with this medication, over-the-counter omeprazole products are used to treat frequent heartburn (occurring 2 or more days a week). Since it may take 1 to 4 days to have full effect, these products do not relieve heartburn right away. For over-the-counter products, carefully read the package instructions to make sure the product is right for you. Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar brand names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.

Regulatory & Marketing

Labeler Name
Meijer Distribution Inc.
Product Type
Human Otc Drug
FDA Application #
ANDA210593
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-01-2020
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 79481-0061-3 identifies a specific commercial package of 3 bottle in 1 carton / 14 capsule in 1 bottle (79481-0061-1) of Omeprazole, a human over the counter drug labeled by Meijer Distribution Inc.. This capsule is formulated for oral use and contains omeprazole magnesium 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 Meijer Distribution Inc. on December 01, 2020. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Omeprazole is used to treat certain stomach and esophagus problems (such as acid reflux, ulcers). It works by decreasing the amount of acid your stomach makes. It relieves symptoms such as heartburn, difficulty swallowing, and persistent cough. This medication helps heal acid damage to the stomach and esophagus, helps prevent ulcers, and may help prevent cancer of the esophagus. Omeprazole belongs to a class of drugs known as proton pump inhibitors (PPIs). If you are self-treating with this medication, over-the-counter omeprazole products are used to treat frequent heartburn (occurring 2 or more days a week). Since it may take 1 to 4 days to have full effect, these products do not relieve heartburn right away. For over-the-counter products, carefully read the package instructions to make sure the product is right for you. Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar brand names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.

How is this Meijer Distribution Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 79481006103. 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 (5-4-1)
79481-0061-3
11-Digit CMS (5-4-2)
79481-0061-03

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