NDC Package 66689-836-99 Methadone Hydrochloride

Methadone Tablet Oral - View Billable Units, 11-Digit Format, RxNorm

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:
66689-836-99
Package Description:
100 TABLET in 1 BOTTLE, PLASTIC
Product Code:
Proprietary Name:
Methadone Hydrochloride
Non-Proprietary Name:
Methadone
Substance Name:
Methadone Hydrochloride
Usage Information:
Methadone hydrochloride tablets are 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 UseBecause 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 [see WARNINGS AND PRECAUTIONS (5.1)], reserve methadone hydrochloride tablets 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 tablets are 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.Limitations of UseMethadone products used for the treatment of opioid addiction in detoxification or maintenance programs are subject to the conditions for distribution and use required under 42 CFR 8.12 [see DOSAGE AND ADMINISTRATION (2.1)].
11-Digit NDC Billing Format:
66689083699
NDC to RxNorm Crosswalk:
  • RxCUI: 864706 - methadone HCl 10 MG Oral Tablet
  • RxCUI: 864706 - methadone hydrochloride 10 MG Oral Tablet
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Vistapharm, Inc.
    Dosage Form:
    Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
  • Active Ingredient(s):
    DEA Schedule:
    Schedule II (CII) Substances
    Sample Package:
    No
    FDA Application Number:
    ANDA204166
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    09-11-2020
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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.

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    Frequently Asked Questions

    What is NDC 66689-836-99?

    The NDC Packaged Code 66689-836-99 is assigned to a package of 100 tablet in 1 bottle, plastic of Methadone Hydrochloride, a human prescription drug labeled by Vistapharm, Inc.. The product's dosage form is tablet and is administered via oral form.

    Is NDC 66689-836 included in the NDC Directory?

    Yes, Methadone Hydrochloride with product code 66689-836 is active and included in the NDC Directory. The product was first marketed by Vistapharm, Inc. on September 11, 2020 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 66689-836-99?

    The 11-digit format is 66689083699. 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 Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-266689-836-995-4-266689-0836-99