Data / Drug companies / Methadone hydrochloride
Methadone hydrochloride: 21 companies and 49 products in the FDA NDC directory
Methadone hydrochloride is listed in the FDA National Drug Code Directory by 21 companies, with 49 products in commercial distribution. 45 of the products (91.8%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet; concentrate; solution, and the newest product started marketing on September 9, 2026.
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- Companies listing it
- 21
- Products
- 49
- Generic (ANDA) products
- 45 (91.8%)
- Application numbers
- 26
- Controlled substance schedule
- Schedule II
- Routes
- Oral, Intravenous, Intramuscular, Subcutaneous
- Brand names
- Methadone Hydrocloride Dye-Free, Sugar-Free, Unflavored, Methadose, Diskets, Methadose Dispersible, Methadose Sugar-Free
- openFDA record search
- api.fda.gov
Companies that list methadone hydrochloride
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| SpecGx LLC | 9 | tablet; concentrate | Generic drugs (ANDA) | June 18, 2021 |
| Hikma Pharmaceuticals USA Inc. | 8 | tablet; concentrate | Generic drugs (ANDA) | June 23, 2010 |
| VistaPharm, LLC | 5 | tablet; concentrate | Generic drugs (ANDA) | November 22, 2018 |
| American Health Packaging | 2 | tablet; solution | Generic drugs (ANDA) | September 9, 2026 |
| Ascend Laboratories, LLC | 2 | tablet | Generic drugs (ANDA) | July 1, 2025 |
| Atlantic Biologicals Corp. | 2 | concentrate | Generic drugs (ANDA) | November 2, 2020 |
| Aurolife Pharma, LLC | 2 | tablet | Generic drugs (ANDA) | September 15, 2015 |
| Camber Pharmaceuticals, Inc. | 2 | tablet | Generic drugs (ANDA) | January 3, 2019 |
| Elite Laboratories, Inc. | 2 | tablet | Generic drugs (ANDA) | August 6, 2018 |
| Epic Pharma, LLC | 2 | tablet | Generic drugs (ANDA) | June 11, 2018 |
| Precision Dose, Inc. | 2 | solution | Generic drugs (ANDA) | December 29, 2023 |
| XLCare Pharmaceuticals, Inc. | 2 | tablet | Generic drugs (ANDA) | January 3, 2019 |
| Breckenridge Pharmaceutical, Inc. | 1 | injection, solution | Generic drugs (ANDA) | December 30, 2024 |
| Bryant Ranch Prepack | 1 | concentrate | Generic drugs (ANDA) | November 2, 2020 |
| Bryant Ranch Prepack | 1 | tablet | Generic drugs (ANDA) | January 16, 2012 |
| Bryant Ranch Prepack | 1 | concentrate | Generic drugs (ANDA) | November 2, 2020 |
| Hikma Pharmaceuticals USA Inc. | 1 | injection | Generic drugs (ANDA) | June 12, 2025 |
| Lannett Company, Inc. | 1 | concentrate | Generic drugs (ANDA) | November 2, 2020 |
| Long Grove Pharmaceuticals, LLC | 1 | injection | Generic drugs (ANDA) | June 28, 2025 |
| Major Pharmaceuticals | 1 | tablet | Generic drugs (ANDA) | January 3, 2024 |
| Mylan Institutional LLC | 1 | injection, solution | New drug applications (NDA) | May 17, 2010 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet | 24 | 49% |
| Concentrate | 13 | 26.5% |
| Solution | 8 | 16.3% |
| Injection, solution | 2 | 4.1% |
| Injection | 2 | 4.1% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 45 | 91.8% |
| New drug applications (NDA) | 4 | 8.2% |
Pharmacologic classes
| Class | Products |
|---|---|
| Opioid Agonist | 49 |
Updated November 6, 2026. Read from US Food and Drug Administration, National Drug Code Directory (openFDA). CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.