Methadone Hydrochloride
NDC Package 17856-3553-2

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 iNTENSOLTM (oral concentrate) is indicated for the:•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 UseoBecause 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, reserve methadone 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.oMethadone is not indicated as an as-needed (prn) analgesic. Marketed by Atlantic Biologicals Corp., this product is identified by NDC 17856-3553 and is authorized under FDA application ANDA089897.

Identification & Billing

NDC Package Code
17856-3553-2
Package Description
60 SYRINGE in 1 BOX, UNIT-DOSE / .5 mL in 1 SYRINGE
Product Code
17856-3553
11-Digit Billing Format
17856355302
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

Clinical Specifications

Proprietary Name
Methadone Hydrochloride
Dosage Form
-
Usage Information
Methadone Hydrochloride INTENSOLTM (oral concentrate) is indicated for the:•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 UseoBecause 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, reserve methadone 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.oMethadone is not indicated as an as-needed (prn) analgesic. •Detoxification treatment of opioid addiction (heroin or other morphine-like drugs).•Maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services.Conditions For Distribution And Use Of Methadone Products For The Treatment Of Opioid AddictionCode of Federal Regulations, Title 42, Sec 8Methadone products when used for the treatment of opioid addiction in detoxification or maintenance programs, shall be dispensed only by opioid treatment programs (and agencies, practitioners or institutions by formal agreement with the program sponsor) certified by the Substance Abuse and Mental Health Services Administration and approved by the designated state authority. Certified treatment programs shall dispense and use methadone in oral form only and according to the treatment requirements stipulated in the Federal Opioid Treatment Standards (42 CFR 8.12). See below for important regulatory exceptions to the general requirement for certification to provide opioid agonist treatment.Failure to abide by the requirements in these regulations may result in criminal prosecution, seizure of the drug supply, revocation of the program approval, and injunction precluding operation of the program.Regulatory Exceptions To The General Requirement For Certification To Provide Opioid Agonist Treatment: During inpatient care, when the patient was admitted for any condition other than concurrent opioid addiction (pursuant to 21CFR 1306.07(c)), to facilitate the treatment of the primary admitting diagnosis). During an emergency period of no longer than 3 days while definitive care for the addiction is being sought in an appropriately licensed facility (pursuant to 21CFR 1306.07(b)).

Regulatory & Marketing

Labeler Name
Atlantic Biologicals Corp.
FDA Application #
ANDA089897
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-31-2018
Listing Expiration
12-31-2019
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 (17856-3553). Click a package code to view its specific billing and regulatory data.

17856-3553-1
60 SYRINGE in 1 BOX, UNIT-DOSE / 1 mL in 1 SYRINGE

* 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 17856-3553-2 identifies a specific commercial package of 60 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 October 31, 2018. The current certification is valid through December 31, 2019.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 17856355302. 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)
17856-3553-2
11-Digit CMS (5-4-2)
17856-3553-02

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