Prilosec Otc Tablet, Delayed Release
NDC Package 84126-301-14

11-digit billing NDC: 84126030114
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Prilosec Otc (omeprazole magnesium) tablets is for adults 18 years of age and olderthis product is to be used once a day (every 24 hours), every day for 14 daysit may take 1 to 4 days for full effect; some people get complete relief of symptoms within 24 hours 14-Day Course of Treatmentswallow 1 tablet with a glass of water before eating in the morningtake every day for 14 daysdo not take more than 1 tablet a daydo not use for more than 14 days unless directed by your doctorswallow whole. This formulation utilizes a tablet, delayed release delivery system. Marketed by The Procter & Gamble Manufacturing Company, this product is identified by NDC 84126-301 and is authorized under FDA application ANDA206582.

Identification & Billing

NDC Package Code
84126-301-14
Package Description
1 BLISTER PACK in 1 CARTON / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK
Product Code
84126-301
11-Digit Billing Format
84126030114
RxNorm Crosswalk
  • RxCUI: 402014 - omeprazole 20 MG Delayed Release Oral Tablet
  • RxCUI: 402014 - omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Tablet
  • RxCUI: 608796 - PriLOSEC OTC 20 MG Delayed Release Oral Tablet
  • RxCUI: 608796 - omeprazole 20 MG Delayed Release Oral Tablet [Prilosec]
  • RxCUI: 608796 - Prilosec 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Tablet

Clinical Specifications

Proprietary Name
Prilosec Otc
Non-Proprietary Name
Omeprazole Magnesium
Substance Name
Omeprazole Magnesium
Dosage Form
Tablet, Delayed Release - A solid dosage form 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 20.6 mg/1
Pharmacologic Class
Usage Information
For adults 18 years of age and olderthis product is to be used once a day (every 24 hours), every day for 14 daysit may take 1 to 4 days for full effect; some people get complete relief of symptoms within 24 hours 14-Day Course of Treatmentswallow 1 tablet with a glass of water before eating in the morningtake every day for 14 daysdo not take more than 1 tablet a daydo not use for more than 14 days unless directed by your doctorswallow whole. Do not chew, crush, or suck tablets.Repeated 14-Day Courses (if needed)you may repeat a 14-day course every 4 monthsdo not take for more than 14 days or more often than every 4 months unless directed by a doctorchildren under 18 years of age: ask a doctor. Heartburn in children may sometimes be caused by a serious condition.

Regulatory & Marketing

Labeler Name
The Procter & Gamble Manufacturing Company
Product Type
Human Otc Drug
FDA Application #
ANDA206582
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-03-2025
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (84126-301). Click a package code to view its specific billing and regulatory data.

84126-301-42
3 BLISTER PACK in 1 CARTON / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK

* 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 84126-301-14 identifies a specific commercial package of 1 blister pack in 1 carton / 14 tablet, delayed release in 1 blister pack of Prilosec Otc, a human over the counter drug labeled by The Procter & Gamble Manufacturing Company. This tablet, 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 The Procter & Gamble Manufacturing Company on June 03, 2025. The current certification is valid through December 31, 2027.

How is this The Procter & Gamble Manufacturing Company product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 84126030114. 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)
84126-301-14
11-Digit CMS (5-4-2)
84126-0301-14

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