Prilosec Otc
NDC Package 54868-5309-0

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Prilosec Otc 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 hours14-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. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-5309 and is authorized under FDA application NDA021229.

Identification & Billing

NDC Package Code
54868-5309-0
Package Description
3 CARTON in 1 CARTON / 1 BLISTER PACK in 1 CARTON / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK
Product Code
54868-5309
11-Digit Billing Format
54868530900
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
3 EA
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
Dosage Form
-
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 hours14-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 or crush 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
Physicians Total Care, Inc.
FDA Application #
NDA021229
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-23-2005
Listing Expiration
12-31-2017
Exclude Flag
I
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 54868-5309-0 identifies a specific commercial package of 3 carton in 1 carton / 1 blister pack in 1 carton / 14 tablet, delayed release in 1 blister pack of Prilosec Otc, labeled by Physicians Total Care, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 3 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Physicians Total Care, Inc. on May 23, 2005. The current certification is valid through December 31, 2017.

How is this Physicians Total Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868530900. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 3 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 (5-4-1)
54868-5309-0
11-Digit CMS (5-4-2)
54868-5309-00

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