Methadone Hydrochloride
NDC Package 49999-839-90

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.

Methadone Hydrochloride is iNDICATIONS AND USAGEFor the treatment of moderate to severe pain not responsive to non-narcotic analgesics.For detoxification treatment of opioid addiction (heroin or other morphine-like drugs).For maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services.Note – Outpatient maintenance and outpatient detoxification treatment may be provided only by Opioid Treatment Programs (OTPs) certified by the Federal Substance Abuse and Mental Health Services Administration (SAMHSA) and registered by the Drug Enforcement Administration (DEA). Marketed by Lake Erie Medical Dba Quality Care Products Llc, this product is identified by NDC 49999-839 and is authorized under FDA application ANDA040517.

Identification & Billing

NDC Package Code
49999-839-90
Package Description
90 TABLET in 1 BOTTLE, PLASTIC
Product Code
49999-839
11-Digit Billing Format
49999083990
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
90 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Methadone Hydrochloride
Dosage Form
-
Usage Information
INDICATIONS AND USAGEFor the treatment of moderate to severe pain not responsive to non-narcotic analgesics.For detoxification treatment of opioid addiction (heroin or other morphine-like drugs).For maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services.Note – Outpatient maintenance and outpatient detoxification treatment may be provided only by Opioid Treatment Programs (OTPs) certified by the Federal Substance Abuse and Mental Health Services Administration (SAMHSA) and registered by the Drug Enforcement Administration (DEA). This does not preclude the maintenance treatment of a patient with concurrent opioid addiction who is hospitalized for conditions other than opioid addiction and who requires temporary maintenance during the critical period of his/her stay, or of a patient whose enrollment has been verified in a program which has been certified for maintenance treatment with methadone.

Regulatory & Marketing

Labeler Name
Lake Erie Medical Dba Quality Care Products Llc
FDA Application #
ANDA040517
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-11-2010
End Marketing Date
12-31-2014
Listing Expiration
12-31-2014
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 49999-839-90 identifies a specific commercial package of 90 tablet in 1 bottle, plastic of Methadone Hydrochloride, labeled by Lake Erie Medical Dba Quality Care Products Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 90 billable units per package. 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 Lake Erie Medical Dba Quality Care Products Llc on October 11, 2010. The current certification is valid through December 31, 2014.

How is this Lake Erie Medical Dba Quality Care Products Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49999083990. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 90 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 (5-3-2)
49999-839-90
11-Digit CMS (5-4-2)
49999-0839-90

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