Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
West-Ward Columbus Inc.
Hikma Pharmaceuticals USA Inc.
058839929
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
0054-0710Application Number
ANDA088109Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
March 1, 2021MethadoneActive
Code: 229809935BClass: ACTIBQuantity: 10 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
METHADONE HYDROCHLORIDE
Product Details
NDC Product Code
0054-0709Application Number
ANDA088108Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
March 1, 2021MethadoneActive
Code: 229809935BClass: ACTIBQuantity: 5 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT