Methadone Hydrochloride Tablet
NDC Package 66689-898-40

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Methadone Hydrochloride tablets is for oral suspension, USP contain methadone, an opioid agonist indicated for the:•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 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. This formulation utilizes a tablet delivery system. Marketed by Vistapharm, Llc, this product is identified by NDC 66689-898 and is authorized under FDA application ANDA075082.

Identification & Billing

NDC Package Code
66689-898-40
Package Description
100 TABLET in 1 BOTTLE
Product Code
66689-898
11-Digit Billing Format
66689089840
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk
  • RxCUI: 864978 - methadone HCl 40 MG Tablet for Oral Suspension
  • RxCUI: 864978 - methadone hydrochloride 40 MG Tablet for Oral Suspension

Clinical Specifications

Proprietary Name
Methadone Hydrochloride
Non-Proprietary Name
Methadone Hydrochloride
Substance Name
Methadone Hydrochloride
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
METHADONE HYDROCHLORIDE 40 mg/1
Pharmacologic Class
Usage Information
Methadone hydrochloride tablets for oral suspension, USP contain methadone, an opioid agonist indicated for the:•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 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)).
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
Vistapharm, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA075082
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-25-1998
Listing Expiration
12-31-2027
Exclude Flag
N
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 66689-898-40 identifies a specific commercial package of 100 tablet in 1 bottle of Methadone Hydrochloride, a human prescription drug labeled by Vistapharm, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 100 billable units per package. This tablet is formulated for oral use and contains methadone hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Vistapharm, Llc on March 25, 1998. The current certification is valid through December 31, 2027.

How is this Vistapharm, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 66689089840. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 total billable units per package. 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 (5-3-2)
66689-898-40
11-Digit CMS (5-4-2)
66689-0898-40

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