NDC Package 17856-3553-1 Methadone Hydrochloride

View Billable Units, 11-Digit Format, RxNorm

Package Information
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Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:

17856-3553-1

Package Description:

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

Product Code:

17856-3553

Proprietary Name:

Methadone Hydrochloride

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)).

11-Digit NDC Billing Format:

17856355301

NDC to 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 Concentrate for Oral Solution

Labeler Name:

Atlantic Biologicals Corp.

Sample Package:

Start Marketing Date:

10-31-2018

Listing Expiration Date:

12-31-2019

Exclude Flag:

Code Structure:

17856 - Atlantic Biologicals Corp.
- 17856-3553 - Methadone Hydrochloride
  - 17856-3553-1 - 60 SYRINGE in 1 BOX, UNIT-DOSE / 1 mL in 1 SYRINGE

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 disclaimer below.

Other Product Packages

The following packages are also available for this product:

NDC Package Code	Package Description
17856-3553-2	60 SYRINGE in 1 BOX, UNIT-DOSE / .5 mL in 1 SYRINGE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 17856-3553-1?

The NDC Packaged Code 17856-3553-1 is assigned to a package of 60 syringe in 1 box, unit-dose / 1 ml in 1 syringe of Methadone Hydrochloride, labeled by Atlantic Biologicals Corp.. The product's dosage form is and is administered via form.

Is NDC 17856-3553 included in the NDC Directory?

No, Methadone Hydrochloride with product code 17856-3553 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Atlantic Biologicals Corp. on October 31, 2018 and its listing in the NDC Directory is set to expire on December 31, 2019 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 17856-3553-1?

The 11-digit format is 17856355301. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-4-1 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-4-1	17856-3553-1	5-4-2	17856-3553-01

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