Prilosec Granule, Delayed Release
NDC Package 70515-625-01

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

Package Information

Prilosec (omeprazole magnesium) granules is omeprazole is used to treat certain stomach and esophagus problems (such as acid reflux, ulcers). This formulation utilizes a granule, delayed release delivery system. Marketed by Covis Pharma Us, Inc, this product is identified by NDC 70515-625 and is authorized under FDA application NDA022056.

Identification & Billing

NDC Package Code
70515-625-01
Package Description
30 GRANULE, DELAYED RELEASE in 1 CARTON
Product Code
70515-625
11-Digit Billing Format
70515062501
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: 797058 - omeprazole 10 MG Delayed Release Granules for Oral Suspension
  • RxCUI: 797058 - omeprazole 10 MG Granules for Oral Suspension
  • RxCUI: 797058 - omeprazole 10 MG (as omeprazole magnesium 11.2 MG) Delayed Release Granules for Oral Suspension
  • RxCUI: 797061 - PriLOSEC 10 MG Delayed Release Granules for Oral Suspension
  • RxCUI: 797061 - omeprazole 10 MG Granules for Oral Suspension [Prilosec]

Clinical Specifications

Proprietary Name
Prilosec
Non-Proprietary Name
Omeprazole Magnesium
Substance Name
Omeprazole Magnesium
Dosage Form
Granule, Delayed Release - A small medicinal particle or grain to which an enteric or other coating has been applied, thus delaying release of the drug until its passage into the intestines.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
OMEPRAZOLE MAGNESIUM 2.5 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).

Regulatory & Marketing

Labeler Name
Covis Pharma Us, Inc
Product Type
Human Prescription Drug
FDA Application #
NDA022056
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-25-2017
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 70515-625-01 identifies a specific commercial package of 30 granule, delayed release in 1 carton of Prilosec, a human prescription drug labeled by Covis Pharma Us, Inc. This granule, delayed release 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 Covis Pharma Us, Inc on August 25, 2017. 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).

How is this Covis Pharma Us, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70515062501. 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)
70515-625-01
11-Digit CMS (5-4-2)
70515-0625-01

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