Active substance
Methadone
- SFDA 2
- US FDA 37
- Health Canada 19
- US price lines 3
- NHS prices 8
- WHO EML 2
- Safety 6
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| METHADONE MARTINDALE PHARMA 2 mg/ml oral solution | 2 mg/ml | Oral solution · Oral use | 12 Bottle | SAR 765.50 | Generic · Prescription | MACARTHYS LABORATORIES Ltd T/A MARTINDALE PHARMACEUTICALS | Valid |
| METHADONE MARTINDALE PHARMA 2 mg/ml oral solution | 2 mg/ml | Oral solution · Oral use | 12 Bottle | SAR 174.00 | Generic · Prescription | MACARTHYS LABORATORIES Ltd T/A MARTINDALE PHARMACEUTICALS | Valid |
Indications — CHI Daman Drug Formulary
ACUTE PANCREATITIS-PAIN MANAGEMENT; ANESTHESIA-SUPPORTIVE AGENTS/ OPIOIDS WITHDRAWAL IN ICU; BURN MANAGEMENT; CHRONIC PANCREATITIS; DIABETIC NEUROPATHY; ENDOMETRIOSIS; LOW BACK PAIN; NEUROPATHIC PAIN; PAIN MANAGEMENT IN CANCER PATIENTS; POST-HERPETIC NEURALGIA; POSTOPERATIVE PAIN; RENAL AND URETERIC STONES
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| METHADONE HYDROCHLORIDE | 10MG/ML | injectable · injection | MYLAN INSTITUTIONAL | Prescription | 13 Aug 1947 |
| METHADONE HYDROCHLORIDE | 40MG | tablet, for suspension · oral | HIKMA PHARMS | Prescription | 14 Mar 1973 |
| METHADOSE | 10MG/ML | concentrate · oral | SPECGX LLC | Prescription | 14 Mar 1973 |
| METHADONE HYDROCHLORIDE | 5MG/5ML | solution · oral | HIKMA PHARMS | Prescription | 22 May 1981 |
| METHADONE HYDROCHLORIDE | 10MG/5ML | solution · oral | HIKMA PHARMS | Prescription | 30 Aug 1982 |
| METHADONE HYDROCHLORIDE | 10MG; 5MG | tablet · oral | HIKMA PHARMS | Prescription | 8 Mar 1983 |
| METHADONE HYDROCHLORIDE INTENSOL | 10MG/ML | concentrate · oral | HIKMA PHARMS | Prescription | 6 Sep 1988 |
| METHADOSE | 40MG | tablet, for suspension · oral | SPECGX LLC | Prescription | 29 Apr 1993 |
| METHADONE HYDROCHLORIDE | 10MG/ML | concentrate · oral | VISTAPHARM LLC | Prescription | 30 Nov 1994 |
| METHADONE HYDROCHLORIDE | 40MG | tablet, for suspension · oral | VISTAPHARM LLC | Prescription | 25 Mar 1998 |
| METHADONE HYDROCHLORIDE | 10MG/ML | concentrate · oral | HIKMA PHARMS | Prescription | 30 Apr 1998 |
| METHADONE HYDROCHLORIDE | 5MG; 10MG | tablet · oral | SPECGX LLC | Prescription | 27 Apr 2004 |
| METHADONE HYDROCHLORIDE | 40MG | tablet, for suspension · oral | SPECGX LLC | Prescription | 12 Jul 2005 |
| METHADONE HYDROCHLORIDE | 10MG; 5MG | tablet · oral | THEPHARMANETWORK LLC | Prescription | 25 Nov 2009 |
| METHADONE HYDROCHLORIDE | 5MG/5ML | solution · oral | VISTAPHARM LLC | Prescription | 30 Jun 2010 |
| METHADONE HYDROCHLORIDE | 5MG; 10MG | tablet · oral | EPIC PHARMA LLC | Prescription | 18 Aug 2015 |
| METHADONE HYDROCHLORIDE | 5MG; 10MG | tablet · oral | AUROLIFE PHARMA LLC | Prescription | 31 Aug 2015 |
| METHADONE HYDROCHLORIDE | 10MG/ML | injectable · injection | LONG GROVE PHARMS | Prescription | 27 Oct 2017 |
| METHADONE HYDROCHLORIDE | 5MG; 10MG | tablet · oral | ELITE LABS INC | Prescription | 2 Aug 2018 |
| METHADONE HYDROCHLORIDE | 5MG; 10MG | tablet · oral | ASCENT PHARMS INC | Prescription | 3 Jan 2019 |
| METHADONE HYDROCHLORIDE | 10MG/ML | concentrate · oral | SPECGX LLC | Prescription | 22 Aug 2019 |
| METHADONE HYDROCHLORIDE | 5MG/5ML; 10MG/5ML | solution · oral | SPECGX LLC | Prescription | 2 Oct 2019 |
| METHADONE HYDROCHLORIDE | 10MG | tablet · oral | VISTAPHARM LLC | Prescription | 16 Mar 2020 |
| METHADONE HYDROCHLORIDE | 10MG/ML | concentrate · oral | LANNETT CO INC | Prescription | 2 Nov 2020 |
| METHADONE HYDROCHLORIDE | 10MG/ML | injectable · injection | BRECKENRIDGE | Prescription | 16 Dec 2024 |
12 more — full table
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| APO-METHADONE | 02533642 | 1 MG | TABLET · ORAL | APOTEX INC |
| APO-METHADONE | 02533650 | 5 MG | TABLET · ORAL | APOTEX INC |
| APO-METHADONE | 02533669 | 10 MG | TABLET · ORAL | APOTEX INC |
| APO-METHADONE | 02533677 | 25 MG | TABLET · ORAL | APOTEX INC |
| JAMP METHADONE ORAL CONCENTRATE | 02495783 | 10 MG / ML | SOLUTION · ORAL | JAMP PHARMA CORPORATION |
| METADOL | 02241377 | 10 MG / ML | SOLUTION · ORAL | KNIGHT THERAPEUTICS INC. |
| METADOL | 02247694 | 1 MG / ML | SOLUTION · ORAL | KNIGHT THERAPEUTICS INC. |
| METADOL | 02247698 | 1 MG | TABLET · ORAL | KNIGHT THERAPEUTICS INC. |
| METADOL | 02247699 | 5 MG | TABLET · ORAL | KNIGHT THERAPEUTICS INC. |
| METADOL | 02247700 | 10 MG | TABLET · ORAL | KNIGHT THERAPEUTICS INC. |
| METADOL | 02247701 | 25 MG | TABLET · ORAL | KNIGHT THERAPEUTICS INC. |
| METADOL-D | 02244290 | 10 MG / ML | SOLUTION · ORAL | KNIGHT THERAPEUTICS INC. |
| METADOL-D | 02247374 | 1 MG / ML | SOLUTION · ORAL | KNIGHT THERAPEUTICS INC. |
| METHADOSE | 02394596 | 10 MG / ML | SOLUTION · ORAL | MALLINCKRODT CANADA ULC |
| METHADOSE | 02394618 | 10 MG / ML | SOLUTION · ORAL | MALLINCKRODT CANADA ULC |
| ODAN-METHADONE | 02495872 | 10 MG / ML | SOLUTION · ORAL | ODAN LABORATORIESLTD |
| ODAN-METHADONE | 02495880 | 10 MG / ML | SOLUTION · ORAL | ODAN LABORATORIESLTD |
| PMS-METHADONE HYDROCHLORIDE ORAL CONCENTRATE | 02552728 | 10 MG / ML | SOLUTION · ORAL | PHARMASCIENCE INC |
| PMS-METHADONE HYDROCHLORIDE ORAL CONCENTRATE | 02552736 | 10 MG / ML | SOLUTION · ORAL | PHARMASCIENCE INC |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | METHADONE 10 MG/ML ORAL CONC | $0.54234 | per ML | 23 Sep 2026 |
| US NADAC | METHADONE HCL 10 MG TABLET | $0.17691 | per EA | 30 Sep 2026 |
| US NADAC | METHADONE HCL 5 MG TABLET | $0.16157 | per EA | 23 Sep 2026 |
| NHS Drug Tariff | Methadone 10mg/1ml solution for injection ampoules | £9.59 | 10 ampoule | 1 Oct 2026 |
| NHS Drug Tariff | Methadone 10mg/ml oral solution sugar free | £12.01 | 150 ml | 1 Oct 2026 |
| NHS Drug Tariff | Methadone 1mg/ml oral solution | £0.94 | 100 ml | 1 Oct 2026 |
| NHS Drug Tariff | Methadone 1mg/ml oral solution | £4.70 | 500 ml | 1 Oct 2026 |
| NHS Drug Tariff | Methadone 1mg/ml oral solution sugar free | £0.95 | 100 ml | 1 Oct 2026 |
| NHS Drug Tariff | Methadone 1mg/ml oral solution sugar free | £4.75 | 500 ml | 1 Oct 2026 |
| NHS Drug Tariff | Methadone 50mg/1ml solution for injection ampoules | £22.29 | 10 ampoule | 1 Oct 2026 |
| NHS Drug Tariff | Methadone 5mg tablets | £19.93 | 50 tablet | 1 Oct 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
WHO WHO Model List of Essential Medicines (2025)
- 24.5.3. Medicines for opioid use disorders · complementary
Opioid dependence
Oral > Liquid: 5 mg per 5 mL (methadone hydrochloride); 10 mg per 5 mL (methadone hydrochloride); 5 mg per mL concentrate for oral liquid (methadone hydrochloride); 10 mg per mL concentrate for oral liquid (methadone hydrochloride) - 2.2. Opioid analgesics · complementary
Chronic cancer pain
Oral > Liquid: 5 mg per 5 mL (methadone hydrochloride); 25 mg per 5 mL (methadone hydrochloride); 50 mg per 5 mL concentrate for oral liquid (methadone hydrochloride) (EML); 10 mg per mL concentrate for oral liquid (methadone hydrochloride) (EML) | Oral > Solid > tablet: 5 mg (methadone hydrochloride); 10 mg (methadone hydrochloride) (EML)
Safety signals and safety-related labeling changes
- US FDA 22 Dec 2025 METHADONE HYDROCHLORIDE — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 22 Dec 2025 METHADONE HYDROCHLORIDE — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 22 Dec 2025 METHADOSE — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 2 Jun 2021 DOLOPHINE HYDROCHLORIDE — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - EMA PRAC 15 Mar 2019 PRAC signal: Opioid toxicity in infants exposed to levomethadone and/or methadone via breast milk
Action for MAH: update of the product information: No - US FDA 1 Feb 2018 METHADONE HYDROCHLORIDE — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.