Osmoprep
NDC Package 54868-5889-0

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

Package Information

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

Osmoprep is a medication used to clean out the intestines before a colonoscopy. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-5889 and is authorized under FDA application NDA021892.

Identification & Billing

NDC Package Code
54868-5889-0
Package Description
32 TABLET in 1 BOTTLE, PLASTIC
Product Code
54868-5889
11-Digit Billing Format
54868588900
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
32 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Osmoprep
Dosage Form
-
Usage Information
This medication is used to clean out the intestines before a colonoscopy. Sodium phosphate is a laxative that works by drawing large amounts of water into the colon, causing you to have watery bowel movements. This cleans out the intestines so that your doctor can clearly view them during your colonoscopy. This medication should not be used for weight loss or constipation due to the possibility of severe side effects.

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
NDA021892
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-30-2008
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (54868-5889). Click a package code to view its specific billing and regulatory data.

54868-5889-1
4 TABLET in 1 BOTTLE, PLASTIC

* 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 54868-5889-0 identifies a specific commercial package of 32 tablet in 1 bottle, plastic of Osmoprep, labeled by Physicians Total Care, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 32 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 30, 2008. The current certification is valid through December 31, 2017.

What are the primary indications for this medication?

This medication is used to clean out the intestines before a colonoscopy. Sodium phosphate is a laxative that works by drawing large amounts of water into the colon, causing you to have watery bowel movements. This cleans out the intestines so that your doctor can clearly view them during your colonoscopy. This medication should not be used for weight loss or constipation due to the possibility of severe side effects.

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: 54868588900. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 32 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)
54868-5889-0
11-Digit CMS (5-4-2)
54868-5889-00

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