NDC Package 17478-380-20 Methadone Hydrochloride

View Billable Units, 11-Digit Format, RxNorm

Package Information
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:

17478-380-20

Package Description:

20 mL in 1 VIAL, MULTI-DOSE

Product Code:

17478-380

Proprietary Name:

Methadone Hydrochloride

Usage Information:

1. For the management of pain severe enough to require an opioid analgesic 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 (see WARNINGS: Addiction, Abuse, and Misuse) reserve Methadone Hydrochloride Injection for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:Have not been tolerated, or are not expected to be tolerated,Have not provided adequate analgesia, or are not expected to provide adequate analgesia.2. For use in temporary treatment of opioid dependence in patients unable to take oral medication. Limitations of UseInjectable methadone products are not approved for the outpatient treatment of opioid dependence. In this patient population, parenteral methadone is to be used only for patients unable to take oral medication, such as hospitalized patients.Conditions for Distribution and Use of Methadone Products for the Treatment of Opioid AddictionCode of Federal Regulations, Title 42, Sec 8.Methadone 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:

17478038020

Billing Unit:

ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

NDC to RxNorm Crosswalk:

20 ML

NDC to RxNorm Crosswalk:

RxCUI: 864714 - methadone 10 MG/ML Injectable Solution

RxCUI: 864714 - methadone hydrochloride 10 MG/ML Injectable Solution

Labeler Name:

Akorn

Sample Package:

Start Marketing Date:

10-30-2017

Listing Expiration Date:

12-31-2023

Exclude Flag:

Code Structure:

17478 - Akorn
- 17478-380 - Methadone Hydrochloride
  - 17478-380-20 - 20 mL in 1 VIAL, MULTI-DOSE

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.

Frequently Asked Questions

What is NDC 17478-380-20?

The NDC Packaged Code 17478-380-20 is assigned to a package of 20 ml in 1 vial, multi-dose of Methadone Hydrochloride, labeled by Akorn. The product's dosage form is and is administered via form.This product is billed per "ML" milliliter and contains an estimated amount of 20 billable units per package.

Is NDC 17478-380 included in the NDC Directory?

No, Methadone Hydrochloride with product code 17478-380 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Akorn on October 30, 2017 and its listing in the NDC Directory is set to expire on December 31, 2023 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 17478-380-20?

The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume. The calculated billable units for this package is 20.

What is the 11-digit format for NDC 17478-380-20?

The 11-digit format is 17478038020. 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 5-3-2 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
5-3-2	17478-380-20	5-4-2	17478-0380-20

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