Reglan
NDC Package 54868-0513-0

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 discontinued by the firm.

Reglan is a medication used to treat certain conditions of the stomach and intestines. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-0513 and is authorized under FDA application NDA017854.

Identification & Billing

NDC Package Code
54868-0513-0
Package Description
30 TABLET in 1 BOTTLE
Product Code
54868-0513
11-Digit Billing Format
54868051300

Clinical Specifications

Proprietary Name
Reglan
Dosage Form
-
Usage Information
This medication is used to treat certain conditions of the stomach and intestines. Metoclopramide is used as a short-term treatment (4 to 12 weeks) for persistent heartburn when the usual medicines do not work well enough. It is used mostly for heartburn that occurs after a meal or during the daytime. Treating persistent heartburn can decrease the damage done by stomach acid to the swallowing tube (esophagus) and help healing. Metoclopramide is also used in diabetic patients who have poor emptying of their stomachs (gastroparesis). Treating gastroparesis can decrease symptoms of nausea, vomiting, and stomach/abdominal fullness. Metoclopramide works by blocking a natural substance (dopamine). It speeds up stomach emptying and movement of the upper intestines. This drug is not recommended for use in children due to an increased risk of serious side effects (such as muscle spasms/uncontrolled muscle movements). Ask the doctor or pharmacist for details.

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
NDA017854
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-05-2003
End Marketing Date
06-30-2012
Listing Expiration
06-30-2012
Exclude Flag
D
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 (54868-0513). Click a package code to view its specific billing and regulatory data.

54868-0513-1
100 TABLET in 1 BOTTLE

* 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 54868-0513-0 identifies a specific commercial package of 30 tablet in 1 bottle of Reglan, labeled by Physicians Total Care, Inc.. 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 05, 2003. The current certification is valid through June 30, 2012.

What are the primary indications for this medication?

This medication is used to treat certain conditions of the stomach and intestines. Metoclopramide is used as a short-term treatment (4 to 12 weeks) for persistent heartburn when the usual medicines do not work well enough. It is used mostly for heartburn that occurs after a meal or during the daytime. Treating persistent heartburn can decrease the damage done by stomach acid to the swallowing tube (esophagus) and help healing. Metoclopramide is also used in diabetic patients who have poor emptying of their stomachs (gastroparesis). Treating gastroparesis can decrease symptoms of nausea, vomiting, and stomach/abdominal fullness. Metoclopramide works by blocking a natural substance (dopamine). It speeds up stomach emptying and movement of the upper intestines. This drug is not recommended for use in children due to an increased risk of serious side effects (such as muscle spasms/uncontrolled muscle movements). Ask the doctor or pharmacist for details.

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: 54868051300. 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)
54868-0513-0
11-Digit CMS (5-4-2)
54868-0513-00

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