Drug

Who makes methadone hydrochloride?

18 companies list methadone hydrochloride as a human prescription drug, including under the names DISKETS, METHADOSE, METHADOSE DISPERSIBLE, METHADOSE SUGAR-FREE. Forms: concentrate; injection; injection, solution; solution; tablet. Routes: intramuscular, intravenous, oral, subcutaneous.

Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology

Companies listing methadone hydrochloride

CompanyFormsApplicationNDCsRegistered sites
SpecGx LLCUnited Statesconcentrate; solution; tabletANDA, NDAANDA040517, ANDA074184, ANDA07714295
Hikma Pharmaceuticals USA Inc.United Statesconcentrate; injection; solution; tabletANDA, NDAANDA040180, ANDA087393, ANDA08799794
VistaPharm, LLCconcentrate; solution; tabletANDAANDA040088, ANDA040241, ANDA07508250
Bryant Ranch PrepackUnited Statesconcentrate; tabletANDAANDA090635, ANDA21209331
Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited Statessolution; tabletANDAANDA087393, ANDA21122825
Aurolife Pharma LLCUnited StatestabletANDAANDA20350223
Epic Laboratories, LLCUnited StatestabletANDAANDA09006523
Camber Pharmaceuticals, Inc.United StatestabletANDAANDA21122821
Elite Laboratories, Inc.United StatestabletANDAANDA21048421
Precision Dose Inc.United StatessolutionANDAANDA08739321
South Atlantic Corporation LLCUnited StatesconcentrateANDAANDA040180, ANDA21209321
XLCare Pharmaceuticals Inc.United StatestabletANDAANDA21122821
ASCEND Therapeutics US, LLCtabletANDAANDA09063520
Lannett Company, LLCUnited StatesconcentrateANDAANDA21209311
Breckenridge Pharmaceutical, Inc.injection, solutionANDAANDA21825210
Long Grove Pharmaceuticals, LLCinjectionANDAANDA20830610
MAJOR Pharmaceuticals Inc.tabletANDAANDA08810910
Mylan Institutional Inc.injection, solutionNDANDA02162410

Bulk ingredient listings

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Common questions

Who makes methadone hydrochloride?
18 companies list methadone hydrochloride as a human prescription drug in the openFDA NDC Directory, led by SpecGx LLC, Hikma Pharmaceuticals USA Inc., VistaPharm, LLC, Bryant Ranch Prepack, Pharma Packaging Solutions, LLC dba Tjoapack, LLC. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
Is there a generic DISKETS?
17 companies list methadone hydrochloride under an abbreviated new drug application (ANDA), the application type used for generics, and 3 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
Who supplies methadone hydrochloride active ingredient?
5 companies list methadone hydrochloride as a bulk ingredient, including SpecGx LLC, Siegfried USA, LLC, MEDISCA Inc., Spectrum Pharmaceuticals, Inc..