NDC Package 17856-3555-8 Methadone Hydrochloride

Solution Oral - View Billable Units, 11-Digit Format, RxNorm

Package Information
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Frequently Asked Questions

Package Information

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:

17856-3555-8

Package Description:

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

Product Code:

17856-3555

Proprietary Name:

Methadone Hydrochloride

Non-Proprietary Name:

Methadone Hydrochloride

Substance Name:

Methadone Hydrochloride

Usage Information:

Methadone Hydrochloride Oral Solution 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 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, 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. •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 Addiction Code ofFederal 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:

17856355508

NDC to RxNorm Crosswalk:

RxCUI: 864761 - methadone HCl 5 MG in 5 mL Oral Solution

RxCUI: 864761 - methadone hydrochloride 1 MG/ML Oral Solution

RxCUI: 864761 - methadone HCl 5 MG per 5 ML Oral Solution

RxCUI: 864769 - methadone HCl 10 MG in 5 mL Oral Solution

RxCUI: 864769 - methadone hydrochloride 2 MG/ML Oral Solution

Product Type:

Human Prescription Drug

Labeler Name:

Atlantic Biologicals Corp.

Dosage Form:

Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

Administration Route(s):

Oral - Administration to or by way of the mouth.

Active Ingredient(s):

METHADONE HYDROCHLORIDE 5 mg/5mL

Pharmacologic Class(es):

Full Opioid Agonists - [MoA] (Mechanism of Action)

Opioid Agonist - [EPC] (Established Pharmacologic Class)

DEA Schedule:

Schedule II (CII) Substances

Sample Package:

FDA Application Number:

ANDA087393

Marketing Category:

ANDA - A product marketed under an approved Abbreviated New Drug Application.

Start Marketing Date:

05-22-1981

Listing Expiration Date:

12-31-2024

Exclude Flag:

Code Structure:

17856 - Atlantic Biologicals Corp.
- 17856-3555 - Methadone Hydrochloride
  - 17856-3555-8 - 120 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
17856-3555-1	2 mL in 1 CUP
17856-3555-2	120 SYRINGE in 1 CASE / 1 mL in 1 SYRINGE
17856-3555-4	60 SYRINGE in 1 BOX, UNIT-DOSE / 1 mL in 1 SYRINGE
17856-3555-5	5 mL in 1 CUP, UNIT-DOSE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 17856-3555-8?

The NDC Packaged Code 17856-3555-8 is assigned to a package of 120 syringe in 1 box, unit-dose / 1 ml in 1 syringe of Methadone Hydrochloride, a human prescription drug labeled by Atlantic Biologicals Corp.. The product's dosage form is solution and is administered via oral form.

Is NDC 17856-3555 included in the NDC Directory?

Yes, Methadone Hydrochloride with product code 17856-3555 is active and included in the NDC Directory. The product was first marketed by Atlantic Biologicals Corp. on May 22, 1981 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 17856-3555-8?

The 11-digit format is 17856355508. 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	17856-3555-8	5-4-2	17856-3555-08

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