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Methadone

Methadone is a long-acting opioid used to manage severe, long-term pain when other treatments aren't enough, and to treat opioid addiction (detoxification and maintenance).

Brand names DolophineMethadose Oral ConcentrateDisketsWestadoneMethadose Dispersible +2 more
Drug class Opioid Agonist
Rx Schedule CII Forms 3
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 36 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 5, 2026 🚨Recall on record
Methadone at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Methadone is a long-acting opioid that acts much like morphine, used for severe, long-term pain when other options fall short and, through certified programs, for opioid addiction; around since about 1973 and available as a generic, it is a mainstay of addiction care and a specialist choice for pain. It is effective and, once the dose is steady, usually well tolerated, though drowsiness, sweating and constipation are common. It remains high-risk, and its boxed warning covers fatal overdose from slowed breathing that can build after starting or raising the dose and from mixing with alcohol, benzodiazepines or other sedatives, so slow breathing or trouble waking someone means calling 911.

Clinical pearls

  • Measure liquid doses with a graduated measuring device, never a kitchen spoon, and double-check mg versus mL.
  • Keep it locked up and keep naloxone at home, since even one dose can kill a child.
  • Tell every prescriber you take methadone; erythromycin, fluconazole, rifampin, some HIV medicines and sertraline can push levels dangerously up or down.
  • Methadone can disturb heart rhythm, so report fainting or a racing heartbeat, and mention diuretics or laxatives that lower potassium.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Methadone can cause fatal overdose, including from dosing mistakes, accidental swallowing by a child, or mixing with other sedating drugs.

  • Dosing errors: With the oral solution, mixing up mg and mL or different strengths can cause accidental overdose. Use a graduated measuring device, never a household spoon.
  • Addiction and misuse: Methadone can lead to addiction, abuse and misuse, which can cause overdose and death.
  • Slowed breathing: This can be fatal, especially at the start or after a dose increase.
  • Accidental ingestion: Even one dose can kill a child.
  • Sedating drugs: Benzodiazepines, alcohol and other depressants can cause deep sedation, coma and death.
  • Pregnancy: Newborns may have withdrawal (NOWS), which is treatable but can be life-threatening if missed.
  • Heart rhythm: QT prolongation and serious arrhythmias have occurred.
  • Drug interactions: Some medicines that change how the liver handles methadone can cause fatal breathing problems.
  • Addiction treatment rules: For opioid addiction, methadone is dispensed only by certified opioid treatment programs.
Read the full warning on DailyMed →
How you get itPrescription only
Comes asTablet, Oral solution, Injection
Earliest FDA record1947
Companies listing it with the FDA19
FDA label last updatedDec 31, 2025
FDA’s strongest warning (boxed)Yes, read the warning

Patient information guide A plain-language walkthrough of Methadone, written from its FDA label.

What Methadone is used for

▾

Methadone is used for pain and opioid addiction, depending on the product.

  • Severe, long-term pain needing around-the-clock opioid treatment when other options are inadequate (methadone tablets, oral solution and oral concentrate Intensol).
  • Severe, persistent pain (methadone injection).
  • Detoxification treatment of opioid addiction (tablets, oral solution, oral concentrates, Diskets, Methadose Dispersible).
  • Maintenance treatment of opioid addiction with social and medical services (the same products).
  • Temporary treatment of opioid dependence when oral medicine cannot be taken, such as in hospitalized patients (injection only).

How Methadone works

▾

Methadone is a synthetic opioid that activates mu-opioid receptors, mostly in the central nervous system and smooth muscle. This relieves pain and eases opioid withdrawal. Its withdrawal is slower, longer and milder than morphine's. It may also block NMDA receptors, though how much this helps is unknown.

Methadone dosage

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Methadone is taken by mouth as a tablet, solution or concentrate, or given as an injection by a professional. Your dose is individualized, so follow your prescriber and label.

  • Use a graduated device for liquid doses, never a household spoon.
  • For opioid addiction, doses come through a certified opioid treatment program.
  • Do not stop suddenly or lower your dose quickly if you are physically dependent.

Dosing details from the FDA-approved label

From the Methadone prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Initiation of Detoxification and Maintenance Treatment of opioid addiction (initial dosing)
    • An initial single dose of 20 to 30 mg of methadone will often be sufficient to suppress withdrawal symptoms
    • Administer under supervision when there are no signs of sedation or intoxication and the patient shows symptoms of withdrawal
    • For same-day adjustment, have the patient wait 2 to 4 hours for evaluation, then provide an additional 5 to 10 mg if withdra
    • Maximum: The initial dose should not exceed 30 mg. The total daily dose on the first day of treatment should not ordinarily exceed 40 mg.
    • Use lower initial doses for patients whose tolerance is expected to be low at treatment entry; any patient who has not taken opioids for more than 5 days may no longer be tolerant.
  • Maintenance Treatment of opioid addiction
    • Clinical stability is most commonly achieved at doses between 80 to 120 mg/day
    • Do not rapidly reduce or abruptly discontinue in a physically-dependent patient.
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION • Consider recommending or prescribing an opioid overdose reversal agent (e.g., naloxone, nalmefene) based on the patient’s risk factors for overdose ( 2.3 , 5.2 , 5.4 , 5.8 ). Management of Pain: • Methadone Hydrochloride Oral Solution should be prescribed only by healthcare professionals who are knowledgeable about the use of extended-release/long-acting opioids and how to mitigate the associated risks. ( 2.1 ) • Use the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals. Reserve titration to higher doses of Methadone Hydrochloride Oral Solution for patients in whom lower doses are insufficiently effective and in whom the expected benefits of using a higher dose opioid clearly outweigh the substantial risks. ( 2.1 , 5 ) • Initiate the dosing regimen for each patient individually, taking into account the patient’s underlying cause and severity of pain, prior analgesic treatment and response, and risk factors for addiction, abuse, and misuse ( 5.2 ) • Respiratory depression can occur at any time during opioid therapy, especially when initiating and following dosage increases with Methadone Hydrochloride Oral Solution. Consider this risk when selecting an initial dose and making dose adjustments ( 2.1 , 5.4 ) • To convert to methadone hydrochloride from another opioid, use available conversion factors to obtain estimated dose. ( 2.4 ) • Titrate slowly with dose increases no more frequent than every 3 to 5 days. ( 2.5 ) • Periodically reassess patients receiving methadone hydrochloride to evaluate the continued need for opioid analgesics to maintain pain control, for the signs or symptoms of adverse reactions, and for the development of addiction, abuse, or misuse. ( 2.5 ) • Do not rapidly reduce or abruptly discontinue methadone in a physically dependent patient because rapid reduction or abrupt discontinuation of opioid analgesics has resulted in serious withdrawal symptoms, uncontrolled pain, and suicide. ( 2.6 , 5.17 ) Initiation of Detoxification and Maintenance Treatment: • A single dose of 20 to 30 mg may be sufficient to suppress withdrawal syndrome.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Methadone side effects

▾

Common side effects include:

Common side effects

  • Lightheadedness
  • Dizziness
  • Sedation (sleepiness)
  • Nausea
  • Vomiting
  • Sweating
  • Constipation
  • Headache

When to get medical help

  • Call 911 or get emergency help right away for slow or shallow breathing, extreme sleepiness, or trouble waking someone, which can signal an overdose.
  • Seek help for fainting, a racing or irregular heartbeat, or palpitations, which can be signs of a dangerous heart rhythm problem (QT prolongation).
  • Get help for agitation, hallucinations, fever, sweating, shivering or muscle twitching, which can signal serotonin syndrome.
  • Call your doctor about signs of withdrawal, such as after starting or stopping another medicine that changes methadone levels.
  • Report an allergic reaction (swelling, trouble breathing, hives).
  • Report seizures, severe dizziness on standing, or unusual weakness, which can signal low blood pressure or adrenal problems.
  • Tell your doctor if you notice new or worsening pain despite treatment.

Methadone warnings and precautions

▾
  • Slowed breathing can be fatal, especially early on or after a dose increase.
  • Risk of addiction, abuse and misuse.
  • Life-threatening heart rhythm changes (QT prolongation).
  • Accidental ingestion, especially by children, can be fatal.
  • Serotonin syndrome, adrenal insufficiency and low blood pressure can occur.
  • Newborn withdrawal (NOWS) after use in pregnancy.

Methadone interactions

▾

Many medicines change methadone's effects.

  • Benzodiazepines, alcohol and other sedatives: dangerous sleepiness and slowed breathing.
  • Liver enzyme blockers (erythromycin, ketoconazole, fluconazole, fluvoxamine): raise methadone levels.
  • Liver enzyme boosters (rifampin, carbamazepine, phenytoin, St. John’s Wort): lower levels and cause withdrawal.
  • QT-prolonging drugs and drugs lowering potassium or magnesium: heart rhythm risk.
  • MAO inhibitors: not recommended within 14 days.
  • Buprenorphine and similar opioids: can cause withdrawal.
  • Serotonin-affecting drugs: serotonin syndrome risk.

Interactions listed in the FDA-approved label

From the Methadone prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Inhibitors of CYP3A4, CYP2B6, CYP2C19, CYP2C9, or CYP2D6 (e.g., macrolide antibiotics, azole-antifungals, protease inhibitors, fluconazole, fluvoxamine, some SSRIs): Can increase methadone plasma concentration, resulting in increased or prolonged opioid effects and possibly fatal overdose; stopping the inhibitor can decrease methadone levels, causing decreased efficacy or withdrawal symptoms. If concomitant use is necessary, consider dosage reduction until stable drug effects are achieved and evaluate frequently for respiratory depression and sedation; if the inhibitor is discontinued, consider increasing the dosage and evaluate for opioid withdrawal.
  • Inducers of CYP3A4, CYP2B6, CYP2C19, or CYP2C9 (e.g., rifampin, carbamazepine, phenytoin, St. John's Wort, phenobarbital): Can decrease methadone plasma concentration, causing decreased efficacy or withdrawal symptoms; after stopping the inducer, methadone concentration can increase and may cause serious respiratory depression, sedation, or death. If concomitant use is necessary, consider increasing the dosage until stable drug effects are achieved and evaluate for withdrawal; if the inducer is discontinued, consider dose reduction and evaluate frequently for respiratory depression and sedation.
  • Benzodiazepines and other CNS depressants (including alcohol, other opioids, gabapentinoids): Additive pharmacologic effect can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death. For pain: reserve concomitant prescribing for patients with inadequate alternatives, limit dosages and durations to the minimum required, and consider an opioid overdose reversal agent. For opioid addiction: cessation of benzodiazepines or other CNS depressants is preferred in most cases, and strongly consider an opioid overdose reversal agent if concomitant
  • Potentially arrhythmogenic agents (QT-prolonging drugs such as Class I and III antiarrhythmics, some neuroleptics, tricyclic antidepressants, calcium channel blockers; drugs inducing electrolyte disturbances such as diuretics, laxatives): Pharmacodynamic interactions may occur with drugs that are potentially arrhythmogenic or capable of inducing electrolyte disturbances (hypomagnesemia, hypokalemia). Evaluate patients closely for cardiac conduction changes.
  • Serotonergic drugs (SSRIs, SNRIs, TCAs, triptans, 5-HT3 receptor antagonists, mirtazapine, trazodone, tramadol, cyclobenzaprine, metaxalone, MAOIs): Concomitant use of opioids with drugs affecting the serotonergic system has resulted in serotonin syndrome. If concomitant use is warranted, frequently evaluate the patient, particularly during initiation and dose adjustment; discontinue methadone if serotonin syndrome is suspected.
  • Monoamine oxidase inhibitors (MAOIs): Interactions with opioids may manifest as serotonin syndrome or opioid toxicity (e.g., respiratory depression, coma). Use is not recommended for patients taking MAOIs or within 14 days of stopping such treatment.
  • Mixed agonist/antagonist and partial agonist opioid analgesics (butorphanol, nalbuphine, pentazocine, buprenorphine): May reduce the analgesic effect of methadone and/or precipitate withdrawal symptoms. Avoid concomitant use.
  • Muscle relaxants (e.g., cyclobenzaprine, metaxalone): Methadone may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression. Decrease the dosage of methadone and/or the muscle relaxant as necessary, and consider recommending or prescribing an opioid overdose reversal agent.
  • Diuretics: Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone. Evaluate for signs of diminished diuresis and/or effects on blood pressure and increase the diuretic dosage as needed.
  • Anticholinergic drugs: May increase risk of urinary retention and/or severe constipation, which may lead to paralytic ileus. Evaluate patients for signs of urinary retention or reduced gastric motility.
Read the label’s full interactions text

7 DRUG INTERACTIONS Inhibitors of CYP3A4, CYP2B6, CYP2C19, CYP2C9, or CYP2D6 Clinical Impact: Methadone undergoes hepatic N-demethylation by several cytochrome P450 (CYP) isoforms, including CYP3A4, CYP2B6, CYP2C19, CYP2C9, and CYP2D6. The concomitant use of Methadone Hydrochloride Oral Solution and CYP3A4, CYP2B6, CYP2C19, CYP2C9, or CYP2D6 inhibitors can increase the plasma concentration of methadone, resulting in increased or prolonged opioid effects, and may result in a fatal overdose, particularly when an inhibitor is added after a stable dose of Methadone Hydrochloride Oral Solution is achieved. These effects may be more pronounced with concomitant use of drugs that inhibit more than one of the CYP enzymes listed above. After stopping a CYP3A4, CYP2B6, CYP2C19, CYP2C9, or CYP2D6 inhibitor, as the effects of the inhibitor decline, the methadone plasma concentration can decrease [see Clinical Pharmacology ( 12.3 )] , resulting in decreased opioid efficacy or withdrawal symptoms in patients physically dependent on methadone. Intervention: If concomitant use is necessary, consider dosage reduction of Methadone Hydrochloride Oral Solution until stable drug effects are achieved. Evaluate patients at frequent intervals for respiratory depression and sedation. If a CYP3A4, CYP2B6, CYP2C19, CYP2C9, or CYP2D6 inhibitor is discontinued, consider increasing the Methadone Hydrochloride Oral Solution dosage until stable drug effects are achieved. Evaluate for signs of opioid withdrawal. Examples: Macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g.

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

🌿223 supplements and herbs with documented Methadone interactions, ranked by severity Check Methadone against a supplement or herb →

Before taking Methadone

▾
  • Do not use with significant breathing problems, severe asthma without monitoring, bowel blockage, or methadone allergy.
  • Tell your doctor about heart rhythm problems.
  • Tell your doctor about a history of addiction or mental illness.
  • Take extra care if elderly, frail, or with chronic lung disease.
  • In pregnancy, newborns may have withdrawal, so plan ahead.
  • While breastfeeding, watch the baby for drowsiness and breathing trouble.

Methadone overdose

▾

Overdose can cause slow breathing, extreme sleepiness progressing to coma, limp muscles, cold clammy skin, pinpoint pupils, a slow heartbeat and low blood pressure. Call 911 right away. Naloxone can reverse breathing problems, but its effect may wear off before methadone does, so monitoring is essential.

What Methadone does in the body

▾

Methadone slows breathing by acting on the brain stem's breathing centers. It narrows the pupils and slows the gut, which causes constipation. It widens blood vessels, which can cause low blood pressure on standing or fainting. Long-term use can lower sex hormones.

How your body processes Methadone

▾

After oral dosing, methadone is absorbed variably and peaks in about 1 to 7.5 hours. It is broken down in the liver by several CYP enzymes into inactive products, which leave in urine and stool. Its half-life varies widely, from about 8 to 59 hours. It lingers in the liver and tissues, so its effects can last longer than blood levels suggest.

How to store Methadone

▾

Dispense in a tight, light-resistant container as defined in the USP/NF. Store at 20° to 25°C (68° to 77°F). Store methadone hydrochloride oral solution securely and dispose of properly .

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

223

Supplements & herbs that interact with Methadone

223 supplements and herbal products have documented interactions with Methadone in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 10
  • Moderate · 174
  • Minor · 39
1,4-BUTANEDIOL Major ACTIVATED CHARCOAL Major BEER Major GAMMA-HYDROXYBUTYRATE (GHB) Major GRAPEFRUIT Major KAVA Major L-TRYPTOPHAN Major LITHIUM Major +215 more
Every supplement checked against Methadone — ranked by severity The full interaction hub: 10 major · 174 moderate · 39 minor · every one linked to its full report. Check Methadone against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

Methadone: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Methadone — the kind of thing our pharmacy team would talk through with you at the counter.

What is methadone used for?

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Depending on the product, it treats severe, long-term pain or opioid addiction, as detox or maintenance. Injection is for pain or short-term use when you can't take pills. It isn't an as-needed pain reliever.

How do I measure the liquid safely?

▾
Always use a graduated measuring device, never a kitchen spoon. Double-check the dose in mg versus mL and the strength on your bottle. If you're unsure, ask me before you take it.

What side effects should I expect?

▾
Dizziness, lightheadedness, sleepiness, nausea, vomiting, sweating and constipation are most common. Call for help if breathing slows, you faint, or your heartbeat feels irregular.

Can I drink alcohol or take other sedating medicines?

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Don't mix them unless your prescriber says so. Alcohol, benzodiazepines and similar drugs can cause deep sedation, slow breathing, coma and death.

Should I have naloxone at home?

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Ask your prescriber. The label strongly encourages considering it, especially if children or others at home could swallow methadone by accident. Still call 911 if you ever use it.

Is methadone safe in pregnancy?

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Tell your doctor right away. Your baby may have withdrawal (NOWS) after birth, which is treatable. Untreated opioid addiction in pregnancy carries its own serious risks, so your doctor will help you weigh them.

Is Methadone available over the counter?

▾
No. Methadone is a prescription medicine: every Methadone product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

Is Methadone a controlled substance?

▾
Yes — Methadone is a federally controlled substance (Schedule II) in the United States, so how it is prescribed, refilled and dispensed is regulated by the DEA.

When was Methadone first available?

▾
The earliest FDA record we hold for Methadone is from 1947: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Methadone was first used.

Who makes Methadone?

▾
19 companies currently list Methadone products in the FDA's NDC Directory, including SpecGx LLC, Hikma Pharmaceuticals USA Inc., VistaPharm, LLC. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Methadone on HelloPharmacist

📊Methadone supplement interactions223 checked — ranked by severity 🌿Drug & Supplement CheckerMethadone vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Methadone NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Methadone Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Methadone forms and strengths (how it comes)

Methadone is available in 3 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Tablet

By mouth
Brands Diskets Methadose Dispersible
How this form is used
What it may be used for
  • Methadone Hydrochloride tablets are used for severe persistent pain and for detoxification and maintenance treatment of opioid addiction.
  • Diskets and Methadose Dispersible tablets are used for detoxification and maintenance treatment of opioid addiction.
Important instructions
  • Diskets are used for opioid addiction under certified opioid treatment program rules.
  • Diskets should not be stopped abruptly or reduced rapidly in a physically dependent person.
Available strengths 3 strengths
5 mg 10 mg 40 mg
64 FDA-listed product records ⓘ

Oral solution

By mouth
Brands Methadone Hydrocloride
How this form is used
What it may be used for
  • Methadone Hydrochloride oral solution is used for severe long-term pain and for detoxification and maintenance treatment of opioid addiction.
  • Methadone Hydrocloride and Methadose oral concentrates are used for detoxification and maintenance treatment of opioid addiction.
Important instructions
  • Methadone Hydrochloride oral solution must be measured with a graduated device, never a household spoon.
  • Methadone Hydrochloride oral solution comes in different concentrations, so check mg versus mL carefully.
Available strengths 3 strengths
5 mg/5 mL 10 mg/5 mL 10 mg/mL
52 FDA-listed product records ⓘ

Injection

Into a muscle · Into a vein · Under the skin
How this form is used
What it may be used for
  • Methadone Hydrochloride injection is used for severe, persistent pain when other options are not adequate.
  • Methadone Hydrochloride injection is used for temporary treatment of opioid dependence in people who cannot take oral medicine, such as hospitalized patients.
Important instructions
  • Methadone Hydrochloride injection is not approved for outpatient treatment of opioid dependence.
  • Methadone Hydrochloride injection is not meant as an as-needed pain reliever.
Available strengths 2 strengths
10 mg/mL 200 mg/20 mL
8 FDA-listed product records ⓘ

Methadone on the U.S. market: products, makers and brands

How Methadone appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

19 companies list 50 Methadone product records with the FDA, mostly as tablet, oral solution, injection; the earliest marketing or approval year on record is 1947. Brand names on the directory include Dolophine, Methadose Oral Concentrate, Diskets and 4 more; the rest are generics.

3
Dose forms ⓘ
19
Labelers (makers, repackagers, distributors)
7
Brand names
50
FDA-listed product records ⓘ
1947
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (10) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

SpecGx LLC18%
Hikma Pharmaceuticals USA Inc.14%
VistaPharm, LLC12%
Bryant Ranch Prepack6%
Atlantic Biologicals Corp.4%
American Health Packaging4%
Other makers42%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Methadone is used (Medicaid data)

A general measure of how commonly Methadone is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Methadone is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

4,056,849
Medicaid prescriptions filled (Q1–Q4 2025)
$25.6M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Methadone prescribed? Of the 1,601 medications we measure, Methadone ranks #51 by Medicaid prescriptions — more than 97% of them.

Where Methadone ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #51 of 1,601
#46 Diclofenac 4,673,607 Rx #47 Lamotrigine 4,467,083 Rx #48 Cyclobenzaprine 4,437,147 Rx #49 Triamcinolone Topical 4,329,207 Rx #50 Duloxetine 4,105,865 Rx #51 Methadone 4,056,849 Rx #52 Guanfacine 4,043,576 Rx #53 Lisdexamfetamine 3,941,773 Rx #54 Cephalexin 3,933,834 Rx #55 Rosuvastatin 3,856,155 Rx #56 Insulin Glargine (rDNA... 3,731,821 Rx

Utilization by Methadone product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 10 mg/mL oral solution is the most-dispensed Methadone product — about 91% of these Medicaid prescriptions.

methadone hydrochloride 10 MG/ML Oral Solution Most dispensed

3,699,474 Medicaid prescriptions (Q1–Q4 2025) 91% of Methadone prescriptions shown $23.7M gross reimbursement (before rebates) ≈ $6.40 per prescription (gross)

Summed across the 8 of 38 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 991147

methadone hydrochloride 40 MG Tablet for Oral Suspension

275,226 Medicaid prescriptions (Q1–Q4 2025) 7% of Methadone prescriptions shown $66,194 gross reimbursement (before rebates) ≈ $0.24 per prescription (gross)

Summed across the 3 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 864978

methadone hydrochloride 10 MG Oral Tablet

46,811 Medicaid prescriptions (Q1–Q4 2025) 1% of Methadone prescriptions shown $1.1M gross reimbursement (before rebates) ≈ $23 per prescription (gross)

Summed across the 9 of 74 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 864706

methadone hydrochloride 5 MG Oral Tablet

23,255 Medicaid prescriptions (Q1–Q4 2025) <1% of Methadone prescriptions shown $406,832 gross reimbursement (before rebates) ≈ $17 per prescription (gross)

Summed across the 6 of 34 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 864718

methadone hydrochloride 1 MG/ML Oral Solution

11,441 Medicaid prescriptions (Q1–Q4 2025) <1% of Methadone prescriptions shown $345,935 gross reimbursement (before rebates) ≈ $30 per prescription (gross)

Summed across the 3 of 15 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 864761

methadone hydrochloride 2 MG/ML Oral Solution

370 Medicaid prescriptions (Q1–Q4 2025) <1% of Methadone prescriptions shown $9,584 gross reimbursement (before rebates) ≈ $26 per prescription (gross)

Summed across the 1 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 864769

methadone hydrochloride 10 MG/ML Injectable Solution

272 Medicaid prescriptions (Q1–Q4 2025) <1% of Methadone prescriptions shown $57,137 gross reimbursement (before rebates) ≈ $210 per prescription (gross)

Summed across the 2 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 864714

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Methadone, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 32 of 175 listed Methadone NDCs with Medicaid activity.

Compare Methadone products

A representative set of FDA-listed product records for Methadone — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 50 of 50 products — FDA National Drug Code Directory. See every product, package size and price: browse all 50 Methadone NDCs →

Methadone recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list one Methadone recall since July 2021. It is still ongoing. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.

Ongoing Class III Dec 19, 2024 · West-Ward Columbus Inc
Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only.
  • Methadone Hydrochloride Tablets, USP, 5mg, 10x10 Unit-Dose Tablets, Rx Only, Distributed by: Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ 07922, NDC 0054-0709-20 Lots: Lot # AC2556A; Exp. 03/2027 FDA record D-0183-2025 →

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Methadone RxCUI 6813 4 dose forms · 9 strengths
  1. Dose form (SCDF) Injectable Solution RxCUI 372807 In current FDA listings
    Clinical drug / strength (SCD) hydrochloride 10 MG/ML RxCUI 864714
  4. Dose form (SCDF) Tablet for Oral Suspension RxCUI 1869549 In current FDA listings
    Clinical drug / strength (SCD) hydrochloride 40 MG RxCUI 864978

Look up RxCUI 6813 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

💵 What Methadone costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Tablet · Oral 10 mg $0.177 per tablet NDC details & price history
Tablet · Oral 5 mg $0.162 per tablet NDC details & price history
Solution · Oral 5 mg/5 mL $0.057 per mL NDC details & price history
Solution · Oral 10 mg/5 mL $0.102 per mL NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Methadone brand names

Methadone is sold under 7 brand names in the FDA directory — Dolophine, Methadose Oral Concentrate, Diskets, Westadone and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Dolophine Methadose Oral Concentrate Diskets Westadone Methadose Dispersible Methadone Hydrocloride Methadose Sugar-free

Who makes Methadone: manufacturers and labelers

19 companies list Methadone products with the FDA. By number of product records, the largest are SpecGx LLC, Hikma Pharmaceuticals USA Inc., VistaPharm, LLC. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

SpecGx LLC 9 Hikma Pharmaceuticals USA Inc. 7 VistaPharm, LLC 6 Bryant Ranch Prepack 3 Atlantic Biologicals Corp. 2 American Health Packaging 2 Ascend Laboratories, LLC 2 Aurolife Pharma, LLC 2 Camber Pharmaceuticals, Inc 2 Elite Laboratories, Inc. 2 Epic Pharma, LLC 2 Hikma Pharmaceuticals USA 2 Precision Dose, Inc. 2 XLCare Pharmaceuticals, Inc 2 Breckenridge Pharmaceutical Inc 1 Lannett Company, Inc. 1 Long Grove Pharmaceuticals, LLC 1 Major Pharmaceuticals 1 Mylan Institutional LLC 1

Methadone drug class (RxNorm)

Methadone belongs to the Opioid Agonist class.

Pharmacologic class Opioid Agonist
Drug family (ATC) Drugs used in opioid dependence
How it works Full Opioid Agonists

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Methadone page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Dec 31, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Methadone.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Methadone after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
36
Finished products in the current FDA directory
50
Companies listing them (makers, repackagers, distributors)
19
FDA labeler codes behind them ⓘ
21
Linked representative label ⓘ
VistaPharm, LLC
Linked label effective
Dec 31, 2025
Composite sections available
26
Linked SPL Set ID
4a44bde6-c348-4316-b0e0-c24b407cb823
Linked SPL Document ID
b76dbddc-b042-47d7-a7a7-f64c7c5c5035
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. VistaPharm, LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →