Relistor
NDC Package 0008-2513-04

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.

Relistor is a medication used to treat constipation caused by opioid medication. Marketed by Wyeth Pharmaceuticals Inc., A Subsidiary Of Pfizer Inc., this product is identified by NDC 0008-2513 and is authorized under FDA application NDA021964.

Identification & Billing

NDC Package Code
0008-2513-04
Package Description
2 TRAY in 1 CARTON / 1 KIT in 1 TRAY * .6 mL in 1 VIAL, SINGLE-DOSE * 1 mL in 1 PACKET
Product Code
0008-2513
11-Digit Billing Format
00008251304

Clinical Specifications

Proprietary Name
Relistor
Dosage Form
-
Usage Information
This medication is used to treat constipation caused by opioid medication. It blocks the effect of opioids on the gut without blocking the effect on pain. Methylnaltrexone belongs to a class of medications known as opioid antagonists.

Regulatory & Marketing

Labeler Name
Wyeth Pharmaceuticals Inc., A Subsidiary Of Pfizer Inc.
FDA Application #
NDA021964
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-01-2008
End Marketing Date
06-30-2011
Listing Expiration
06-30-2011
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 (0008-2513). Click a package code to view its specific billing and regulatory data.

0008-2513-02
7 TRAY in 1 CARTON / 1 KIT in 1 TRAY * .6 mL in 1 VIAL, SINGLE-DOSE * 1 mL in 1 PACKET
0008-2513-05
1 TRAY in 1 CARTON / 1 KIT in 1 TRAY * .6 mL in 1 VIAL, SINGLE-DOSE * 1 mL in 1 PACKET

* 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 0008-2513-04 identifies a specific commercial package of 2 tray in 1 carton / 1 kit in 1 tray * .6 ml in 1 vial, single-dose * 1 ml in 1 packet of Relistor, labeled by Wyeth Pharmaceuticals Inc., A Subsidiary Of Pfizer 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 Wyeth Pharmaceuticals Inc., A Subsidiary Of Pfizer Inc. on August 01, 2008. The current certification is valid through June 30, 2011.

What are the primary indications for this medication?

This medication is used to treat constipation caused by opioid medication. It blocks the effect of opioids on the gut without blocking the effect on pain. Methylnaltrexone belongs to a class of medications known as opioid antagonists.

How is this Wyeth Pharmaceuticals Inc., A Subsidiary Of Pfizer Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00008251304. 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 (4-4-2)
0008-2513-04
11-Digit CMS (5-4-2)
00008-2513-04

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