FDA label
What is Methadose used for?
Methadose contains methadone. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “METHADOSE contains 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.”
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Methadose, concentrate
Indications and Usage, quoted from the label by SpecGx LLC (NDA017116). Cross-references to other label sections are left out.
METHADOSE contains 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 21 CFR, Title 42, Sec 8.
Source: DailyMed label, set id 808a9d0b-720b-4034-a862-5122ff514608, version 41, effective April 27, 2026. NDC 0406-0527, one of 2 listings for this product.
Questions
What is Methadose used for?
The FDA label says: “METHADOSE contains 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.”
What drug class is Methadose?
FDA lists methadone in the Opioid Agonist established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
More on Methadose
- Is Methadose a controlled substance?Schedule II
- Generic for MethadoseFDA Orange Book
- What is Methadone used for?FDA label uses
- Is Methadone a controlled substance?Schedule II
- Generic for Dolophine HydrochlorideFDA Orange Book
- Opioid Agonists listFDA drug class
- NDC 0406-0527Methadose NDC record
- NDC 0406-8725Methadose NDC record
- Schedule II drugs listDEA schedule