Methadone Hydrochloride
NDC Package 42549-577-28

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 inactivated by the FDA.

Methadone Hydrochloride is for 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. Marketed by Stat Rx Usa Llc, this product is identified by NDC 42549-577 and is authorized under FDA application ANDA040517.

Identification & Billing

NDC Package Code
42549-577-28
Package Description
28 TABLET in 1 BOTTLE
Product Code
42549-577
11-Digit Billing Format
42549057728
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
28 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Methadone Hydrochloride
Dosage Form
-
Usage Information
For 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.

Regulatory & Marketing

Labeler Name
Stat Rx Usa Llc
FDA Application #
ANDA040517
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-19-2009
Listing Expiration
12-31-2017
Exclude Flag
I
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 (42549-577). Click a package code to view its specific billing and regulatory data.

42549-577-02
112 TABLET in 1 BOTTLE

* 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 42549-577-28 identifies a specific commercial package of 28 tablet in 1 bottle of Methadone Hydrochloride, labeled by Stat Rx Usa Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 28 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 Stat Rx Usa Llc on May 19, 2009. The current certification is valid through December 31, 2017.

How is this Stat Rx Usa Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42549057728. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 28 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)
42549-577-28
11-Digit CMS (5-4-2)
42549-0577-28

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