METHADONE HYDROCHLORIDE
These highlights do not include all the information needed to use METHADONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE TABLETS. METHADONE HYDROCHLORIDE tablets, for oral use CIIInitial U.S. Approval: 1947
Approved
Approval ID
50f14803-78c0-4d19-8b5d-9a9c17582ac1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 26, 2023
Manufacturers
FDA
Hikma Pharmaceuticals USA Inc.
DUNS: 080189610
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
METHADONE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0054-0710
Application NumberANDA088109
Product Classification
M
Marketing Category
C73584
G
Generic Name
METHADONE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateMarch 1, 2021
FDA Product Classification
INGREDIENTS (4)
METHADONE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 229809935B
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
METHADONE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0054-0709
Application NumberANDA088108
Product Classification
M
Marketing Category
C73584
G
Generic Name
METHADONE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateMarch 1, 2021
FDA Product Classification
INGREDIENTS (4)
METHADONE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: 229809935B
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT