Active ingredient
Methadone
50 finished FDA listings contain Methadone as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- METHADONE HYDROCHLORIDE
- Dosage forms
- Concentrate, Injection, Injection, Solution, Solution, Tablet
- Routes
- Intramuscular, Intravenous, Oral, Subcutaneous
- Manufacturers / labelers
- 20
- Strengths listed
- 10 mg/1 · 10 mg/5ml · 10 mg/ml · 200 mg/20ml · 40 mg/1 · 5 mg/1 · 5 mg/5ml
- Brand names in FDA listings
- Diskets, Methadone Hydrochloride, Methadone Hydrocloride Dye-Free, Sugar-Free, Unflavored, Methadose, Methadose Dispersible, Methadose Sugar-Free
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 6813
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 021624 | MYLAN INSTITUTIONAL | 1947-08-13 | 1 |
| NDA 017058 | HIKMA | 1973-03-14 | 1 |
| NDA 017116 | SPECGX LLC | 1973-03-14 | 2 |
| ANDA 087393 | HIKMA | 1981-05-22 | 4 |
| ANDA 087997 | HIKMA | 1982-08-30 | 1 |
| ANDA 088109 | HIKMA | 1983-03-08 | 3 |
| ANDA 089897 | HIKMA | 1988-09-06 | 2 |
| ANDA 074184 | SPECGX LLC | 1993-04-29 | 1 |
| ANDA 040088 | VISTAPHARM LLC | 1994-11-30 | 2 |
| ANDA 075082 | VISTAPHARM LLC | 1998-03-25 | 1 |
| ANDA 040180 | HIKMA | 1998-04-30 | 2 |
| ANDA 040241 | VISTAPHARM LLC | 1998-05-29 | 1 |
| ANDA 040517 | SPECGX LLC | 2004-04-27 | 2 |
| ANDA 077142 | SPECGX LLC | 2005-07-12 | 1 |
| ANDA 090635 | THEPHARMANETWORK LLC | 2009-11-25 | 3 |
| ANDA 090707 | VISTAPHARM LLC | 2010-06-30 | 1 |
| ANDA 090065 | EPIC PHARMA LLC | 2015-08-18 | 2 |
| ANDA 203502 | AUROLIFE PHARMA LLC | 2015-08-31 | 2 |
| ANDA 208306 | LONG GROVE PHARMS | 2017-10-27 | 1 |
| ANDA 210484 | ELITE LABS INC | 2018-08-02 | 2 |
| ANDA 211228 | ASCENT PHARMS INC | 2019-01-03 | 5 |
| ANDA 207368 | SPECGX LLC | 2019-08-22 | 1 |
| ANDA 207537 | SPECGX LLC | 2019-10-02 | 2 |
| ANDA 204166 | VISTAPHARM LLC | 2020-03-16 | 1 |
| ANDA 212093 | LANNETT CO INC | 2020-11-02 | 4 |
| ANDA 218252 | BRECKENRIDGE | 2024-12-16 | 1 |
| ANDA 218609 | HIKMA | 2025-05-05 | 1 |
Official labeling on DailyMed
- METHADONE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING] · version 2 · 2026-09-10
- METHADONE HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] · version 18 · 2026-08-11
- METHADOSE DISPERSIBLE (METHADONE HYDROCHLORIDE) TABLET METHADONE HYDROCHLORIDE TABLET [SPECGX LLC] · version 36 · 2026-08-06
- METHADONE HYDROCHLORIDE INJECTION [LONG GROVE PHARMACEUTICALS, LLC] · version 3 · 2026-08-05
- METHADONE HYDROCHLORIDE CONCENTRATE [SPECGX LLC] · version 8 · 2026-08-03
- METHADONE HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS] · version 5 · 2026-07-28
- METHADONE HYDROCHLORIDE CONCENTRATE [ATLANTIC BIOLOGICALS CORP.] · version 7 · 2026-07-13
- METHADONE HYDROCHLORIDE CONCENTRATE [HIKMA PHARMACEUTICALS USA INC.] · version 12 · 2026-06-29
- METHADONE HYDROCHLORIDE INJECTION, SOLUTION [BRECKENRIDGE PHARMACEUTICAL INC] · version 3 · 2026-06-18
- METHADONE HYDROCHLORIDE CONCENTRATE [HIKMA PHARMACEUTICALS USA] · version 18 · 2026-05-20
- METHADONE HYDROCHLORIDE SOLUTION [SPECGX LLC] · version 10 · 2026-05-04
- METHADOSE (METHADONE HYDROCHLORIDE) CONCENTRATE METHADOSE SUGAR-FREE (METHADONE HYDROCHLORIDE) CONCENTRATE [SPECGX LLC] · version 41 · 2026-05-01
Showing the 12 most recent of 35 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.