Methadose Concentrate
NDC Package 0406-8725-10

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

Methadose (methadone hydrochloride) concentrates is a medication used to treat severe ongoing pain (such as due to cancer). This formulation utilizes a concentrate delivery system. Marketed by Specgx Llc, this product is identified by NDC 0406-8725 and is authorized under FDA application NDA017116.

Identification & Billing

NDC Package Code
0406-8725-10
Package Description
1000 mL in 1 BOTTLE, PLASTIC
Product Code
0406-8725
11-Digit Billing Format
00406872510
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
1000 ML
RxNorm Crosswalk
  • RxCUI: 991147 - methadone HCl 10 MG in 1 mL Concentrate for Oral Solution
  • RxCUI: 991147 - methadone hydrochloride 10 MG/ML Oral Solution
  • RxCUI: 991147 - methadone hydrochloride 10 MG per 1 ML Oral Solution
  • RxCUI: 991147 - methadone hydrochloride 5 MG per 0.5 ML Oral Solution
  • RxCUI: 991149 - Methadose 10 MG in 1 mL Concentrate for Oral Solution

Clinical Specifications

Proprietary Name
Methadose Sugar-free
Non-Proprietary Name
Methadone Hydrochloride
Substance Name
Methadone Hydrochloride
Dosage Form
Concentrate - A liquid preparation of increased strength and reduced volume which is usually diluted prior to administration.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
METHADONE HYDROCHLORIDE 10 mg/mL
Pharmacologic Class
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.
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
Specgx Llc
Product Type
Human Prescription Drug
FDA Application #
NDA017116
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-14-1973
Listing Expiration
12-31-2027
Exclude Flag
N
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 (0406-8725). Click a package code to view its specific billing and regulatory data.

0406-8725-15
15000 mL 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 0406-8725-10 identifies a specific commercial package of 1000 ml in 1 bottle, plastic of Methadose Sugar-free, a human prescription drug labeled by Specgx Llc. This product is billed per "ML" milliliter and contains an estimated amount of 1000 billable units per package. This concentrate is formulated for oral use and contains methadone hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Specgx Llc on March 14, 1973. The current certification is valid through December 31, 2027.

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 Specgx Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00406872510. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 1000 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 (4-4-2)
0406-8725-10
11-Digit CMS (5-4-2)
00406-8725-10

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