What is methadone used for?

Indications and Usage, quoted from the label by SpecGx LLC (ANDA074184). Cross-references to other label sections are left out.

Methadone hydrochloride tablets for oral suspension 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.

Limitations of Use Methadone 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.

Source: DailyMed label, set id 544483e6-6f9d-4371-9e93-313e54e0ea05, version 36, effective August 4, 2026. NDC 0406-0540, one of 24 listings for this product.

Indications and Usage, quoted from the label by Hikma Pharmaceuticals USA Inc. (ANDA089897). Cross-references to other label sections are left out.

Methadone Hydrochloride Oral Concentrate (Intensol™) contains methadone, an opioid agonist 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

• oBecause 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 Intensol™ 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 Hydrochloride Intensol™ 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.

Methadone products used for the treatment of opioid addiction in detoxification or maintenance programs are subject to the conditions for distribution and use required under 21 CFR, Title 42, Sec. 8.

Source: DailyMed label, set id d0e6a966-179a-45e0-8444-4c1b8523f8d2, version 12, effective March 6, 2026. NDC 0054-3553, one of 11 listings for this product.

Indications and Usage, quoted from the label by SpecGx LLC (ANDA207537). Cross-references to other label sections are left out.

Methadone hydrochloride oral solution is indicated for the:

• Management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Use:
• Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration, and persist over the course of therapy, reserve opioid analgesics, including methadone hydrochloride oral solution, for use in patients for whom alternative treatment options 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. Limitations of Use: Methadone 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.

Source: DailyMed label, set id 5baef1bf-8bf0-429c-a4ce-1c93171f3f15, version 10, effective April 28, 2026. NDC 0406-6221, one of 8 listings for this product.