Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Epic Pharma, LLC
827915443
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Epic Pharma, LLC
Epic Pharma, LLC
Epic Pharma, LLC
827915443
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Methadone Hydrochloride
Product Details
NDC Product Code
42806-317Application Number
ANDA090065Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 18, 2019MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MethadoneActive
Code: 229809935BClass: ACTIBQuantity: 5 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
Methadone Hydrochloride
Product Details
NDC Product Code
42806-318Application Number
ANDA090065Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 18, 2019MethadoneActive
Code: 229809935BClass: ACTIBQuantity: 10 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT