Omeprazole Capsule, Delayed Release
NDC Package 51316-271-03

11-digit billing NDC: 51316027103
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Omeprazole (omeprazole magnesium) capsules is •for adults 18 years of age and older•this product is to be used once a day (every 24 hours), every day for 14 days•it may take 1 to 4 days for full effect; some people get complete relief of symptoms within 24 hours 14-Day Course of Treatment•swallow 1 capsule with a glass of water before eating in the morning•take every day for 14 days•do not take more than 1 capsule a day•do not use for more than 14 days unless directed by your doctor•swallow whole. This formulation utilizes a capsule, delayed release delivery system. Marketed by Cvs Woonsocket Prescription Center, Incorporated, this product is identified by NDC 51316-271 and is authorized under FDA application ANDA216096.

Identification & Billing

NDC Package Code
51316-271-03
Package Description
3 BOTTLE in 1 CARTON / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (51316-271-01)
Product Code
51316-271
11-Digit Billing Format
51316027103
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 Magnesium
Substance Name
Omeprazole Magnesium
Dosage Form
Capsule, Delayed Release - 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, and which releases a drug (or drugs) at a time other than promptly after administration. Enteric-coated articles are delayed release dosage forms.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
OMEPRAZOLE MAGNESIUM 20 mg/1
Pharmacologic Class
Usage Information
•for adults 18 years of age and older•this product is to be used once a day (every 24 hours), every day for 14 days•it may take 1 to 4 days for full effect; some people get complete relief of symptoms within 24 hours 14-Day Course of Treatment•swallow 1 capsule with a glass of water before eating in the morning•take every day for 14 days•do not take more than 1 capsule a day•do not use for more than 14 days unless directed by your doctor•swallow whole. Do not chew or crush capsules. Repeated 14-Day Courses (if needed)•you may repeat a 14-day course every 4 months•do not take for more than 14 days or more often than every 4 months unless directed by a doctor•children under 18 years of age: ask a doctor. Heartburn in children may sometimes be caused by a serious condition.

Regulatory & Marketing

Labeler Name
Cvs Woonsocket Prescription Center, Incorporated
Product Type
Human Otc Drug
FDA Application #
ANDA216096
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-01-2025
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 51316-271-03 identifies a specific commercial package of 3 bottle in 1 carton / 14 capsule, delayed release in 1 bottle (51316-271-01) of Omeprazole, a human over the counter drug labeled by Cvs Woonsocket Prescription Center, Incorporated. This capsule, 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 Cvs Woonsocket Prescription Center, Incorporated on April 01, 2025. The current certification is valid through December 31, 2027.

How is this Cvs Woonsocket Prescription Center, Incorporated product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51316027103. 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)
51316-271-03
11-Digit CMS (5-4-2)
51316-0271-03

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