Quick answers
- What is Methadone hydrochloride used for?
- The FDA-approved label (Methadone Hydrochloride, Mylan Institutional LLC, December 31, 2025) says: “1. Methadone Hydrochloride Injection 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. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Methadone hydrochloride have a boxed warning?
- Yes. The FDA label for Methadone Hydrochloride has a boxed warning (“WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF METHADONE HYDROCHLORIDE INJECTION”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Methadone hydrochloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Methadone hydrochloride been recalled?
- FDA enforcement reports list 4 recalls of products of this medicine; the newest started December 19, 2024 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Methadone hydrochloride?
- 19 companies list prescription products of Methadone hydrochloride in the FDA NDC Directory, including SpecGx LLC, Hikma Pharmaceuticals USA Inc. and VistaPharm, LLC.
What Methadone hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
1. Methadone Hydrochloride Injection 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. …
— FDA label: Methadone Hydrochloride, Mylan Institutional LLC, effective December 31, 2025. Read the full label on DailyMed →
The FDA has 35 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF METHADONE HYDROCHLORIDE INJECTION
. Read it on the full label →
35 of 35 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet · Concentrate · Solution · Injection, solution · Injection |
|---|---|
| Route | Oral · Intravenous · Intramuscular · Subcutaneous |
| Prescription products | 50 in the FDA NDC Directory |
| Brand names | Methadone Hydrocloride Dye-Free, Sugar-Free, Unflavored, Methadose, Methadose Sugar-Free, Methadose Dispersible, Diskets |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| methadone hydrochloride 10 mg tablet | Generic | $0.1817 per tablet |
| methadone hydrochloride 10 mg/mL concentrate | Generic | $0.5283 per mL |
| methadone hydrochloride 5 mg tablet | Generic | $0.1649 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- SpecGx LLC9 products
- Hikma Pharmaceuticals USA Inc.7 products
- VistaPharm, LLC6 products
- Bryant Ranch Prepack3 products
- Hikma Pharmaceuticals USA2 products
- Epic Pharma, LLC2 products
- American Health Packaging2 products
- Ascend Laboratories, LLC2 products
- Camber Pharmaceuticals, Inc.2 products
- XLCare Pharmaceuticals, Inc.2 products
- Atlantic Biologicals Corp.2 products
- Elite Laboratories, Inc.2 products
- Aurolife Pharma, LLC2 products
- Precision Dose, Inc.2 products
- Mylan Institutional LLC1 product
- Major Pharmaceuticals1 product
- Long Grove Pharmaceuticals, LLC1 product
- Breckenridge Pharmaceutical, Inc.1 product
- Lannett Company, Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA017058 METHADONE HYDROCHLORIDE | Hikma | March 14, 1973 | 22, latest December 22, 2025 2025: Labeling · 2023: Labeling · 2021: Labeling |
| NDA017116 METHADOSE | Specgx LLC | March 14, 1973 | 23, latest December 22, 2025 2025: Labeling · 2023: Labeling · 2021: Labeling |
| NDA021624 METHADONE HYDROCHLORIDE | Mylan Institutional | August 13, 1947 | 8, latest December 22, 2025 2025: Labeling · 2023: Labeling · 2022: Labeling |
Generic approvals (24)
- ANDA087393Hikma · May 22, 1981
- ANDA087997Hikma · August 30, 1982
- ANDA088109Hikma · March 8, 1983
- ANDA089897Hikma · September 6, 1988
- ANDA074184Specgx LLC · April 29, 1993
- ANDA040088Vistapharm LLC · November 30, 1994
- ANDA075082Vistapharm LLC · March 25, 1998
- ANDA040180Hikma · April 30, 1998
- ANDA040241Vistapharm LLC · May 29, 1998
- ANDA040517Specgx LLC · April 27, 2004
- ANDA077142Specgx LLC · July 12, 2005
- ANDA090635Thepharmanetwork LLC · November 25, 2009
- ANDA090707Vistapharm LLC · June 30, 2010
- ANDA090065Epic Pharma LLC · August 18, 2015
- ANDA203502Aurolife Pharma LLC · August 31, 2015
- ANDA208306Long Grove Pharms · October 27, 2017
- ANDA210484Elite Labs Inc · August 2, 2018
- ANDA211228Ascent Pharms Inc · January 3, 2019
- ANDA207368Specgx LLC · August 22, 2019
- ANDA207537Specgx LLC · October 2, 2019
- ANDA204166Vistapharm LLC · March 16, 2020
- ANDA212093Lannett Co Inc · November 2, 2020
- ANDA218252Breckenridge · December 16, 2024
- ANDA218609Hikma · May 5, 2025
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
December 19, 2024 · Class III · Ongoing · D-0183-2025
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 — West-Ward Columbus Inc
-
January 18, 2017 · Class II · Terminated · D-0466-2017
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II (Sugar Free), 1 liter (1000 mL), 4 bottles per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-695-79. — VistaPharm, Inc.
-
January 18, 2017 · Class II · Terminated · D-0467-2017
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Methadone Hydrochloride Oral Concentrate, USP 5 mg/5 mL C-II, 500 mL, 6 bottles per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-711-16. — VistaPharm, Inc.
-
January 18, 2017 · Class II · Terminated · D-0465-2017
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II, a.) 1 fl. oz. (30 mL), 12 bottles per case (NDC No. 66689-695-30), b). 1 liter (1000 mL), 4 bottles per case, (NDC No. 66689-695-79), Rx only, Manufactured by — VistaPharm, Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Methadone Hydrochloride, Mylan Institutional LLC, effective December 31, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →