Methadone Hydrochloride
NDC Package 17856-3554-2

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 oral Solution is 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 Use•Because 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 (5.2)], reserve Methadone Hydrochloride Oral Solution 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 Oral Solution is 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)]. Marketed by Atlantic Biologicals Corp., this product is identified by NDC 17856-3554 and is authorized under FDA application ANDA087393.

Identification & Billing

NDC Package Code
17856-3554-2
Package Description
48 SYRINGE in 1 BOX, UNIT-DOSE / 5 mL in 1 SYRINGE
Product Code
17856-3554
11-Digit Billing Format
17856355402
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Methadone Hydrochloride
Dosage Form
-
Usage Information
Methadone Hydrochloride Oral Solution is 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 Use•Because 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 (5.2)], reserve Methadone Hydrochloride Oral Solution 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 Oral Solution is 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)].

Regulatory & Marketing

Labeler Name
Atlantic Biologicals Corp.
FDA Application #
ANDA087393
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-13-2019
Listing Expiration
12-31-2025
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 (17856-3554). Click a package code to view its specific billing and regulatory data.

17856-3554-1
48 SYRINGE in 1 BOX, UNIT-DOSE / 5 mL in 1 SYRINGE
17856-3554-3
72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE / 10 mL in 1 CUP, UNIT-DOSE

* 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 17856-3554-2 identifies a specific commercial package of 48 syringe in 1 box, unit-dose / 5 ml in 1 syringe of Methadone Hydrochloride, labeled by Atlantic Biologicals Corp.. 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 Atlantic Biologicals Corp. on March 13, 2019. The current certification is valid through December 31, 2025.

How is this Atlantic Biologicals Corp. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 17856355402. 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)
17856-3554-2
11-Digit CMS (5-4-2)
17856-3554-02

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