Methadose
NDC Package 50436-0527-1

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 discontinued by the firm.

Methadose is a medication used to treat severe ongoing pain (such as due to cancer). Marketed by Unit Dose Services, this product is identified by NDC 50436-0527 and is authorized under FDA application NDA017116.

Identification & Billing

NDC Package Code
50436-0527-1
Package Description
.5 mL in 1 SYRINGE
Product Code
50436-0527
11-Digit Billing Format
50436052701

Clinical Specifications

Proprietary Name
Methadose
Dosage Form
-
Usage Information
This medication is used to treat severe ongoing pain (such as due to cancer). Methadone belongs to a class of drugs known as opioid analgesics. It works in the brain to change how your body feels and responds to pain. Do not use this medication to relieve pain that is mild or that will go away in a few days (such as pain from surgery). This medication is not for occasional ("as needed") use. This medication is also used to treat addiction to opioids (such as heroin) as part of an approved treatment program. It helps prevent withdrawal symptoms caused by stopping other opioids.

Regulatory & Marketing

Labeler Name
Unit Dose Services
FDA Application #
NDA017116
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-10-2010
End Marketing Date
03-11-2010
Listing Expiration
03-11-2010
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 50436-0527-1 identifies a specific commercial package of .5 ml in 1 syringe of Methadose, labeled by Unit Dose Services. 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 Unit Dose Services on March 10, 2010. The current certification is valid through March 11, 2010.

What are the primary indications for this medication?

This medication is used to treat severe ongoing pain (such as due to cancer). Methadone belongs to a class of drugs known as opioid analgesics. It works in the brain to change how your body feels and responds to pain. Do not use this medication to relieve pain that is mild or that will go away in a few days (such as pain from surgery). This medication is not for occasional ("as needed") use. This medication is also used to treat addiction to opioids (such as heroin) as part of an approved treatment program. It helps prevent withdrawal symptoms caused by stopping other opioids.

How is this Unit Dose Services product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50436052701. 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)
50436-0527-1
11-Digit CMS (5-4-2)
50436-0527-01

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