Methadone Hydrochloride Tablet
NDC Package 0406-5771-01

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

Methadone Hydrochloride tablets are indicated for the:1.     Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. This formulation utilizes a tablet delivery system. Marketed by Specgx Llc, this product is identified by NDC 0406-5771 and is authorized under FDA application ANDA040517.

Identification & Billing

NDC Package Code
0406-5771-01
Package Description
100 TABLET in 1 BOTTLE
Product Code
0406-5771
11-Digit Billing Format
00406577101
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Methadone Hydrochloride
Non-Proprietary Name
Methadone Hydrochloride
Substance Name
Methadone Hydrochloride
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
METHADONE HYDROCHLORIDE 10 mg/1
Pharmacologic Class
Usage Information
Methadone hydrochloride tablets are indicated for the:1.     Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of UseBecause of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with long-acting opioids [see Warnings and Precautions (5.1)], reserve methadone hydrochloride tablets for use in patients for whom alternative analgesic treatment options (e.g., non-opioid analgesics or immediate-release opioid analgesics) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Methadone hydrochloride tablets are not indicated as an as-needed (prn) analgesic.2.     Detoxification treatment of opioid addiction (heroin or other morphine-like drugs).3.     Maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services. Limitations of UseMethadone products used for the treatment of opioid addiction in detoxification or maintenance programs are subject to the conditions for distribution and use required under 42 CFR 8.12 [see Dosage and Administration (2.1)].
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
Specgx Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA040517
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-27-2004
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 (0406-5771). Click a package code to view its specific billing and regulatory data.

0406-5771-23
1 TABLET in 1 BLISTER PACK
0406-5771-62
100 TABLET in 1 BLISTER PACK

* 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 0406-5771-01 identifies a specific commercial package of 100 tablet in 1 bottle of Methadone Hydrochloride, a human prescription drug labeled by Specgx Llc. This tablet 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 April 27, 2004. The current certification is valid through December 31, 2027.

How is this Specgx Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00406577101. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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)
0406-5771-01
11-Digit CMS (5-4-2)
00406-5771-01

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