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, CII Initial U.S. Approval: 1947
Approved
Approval ID
3ce98ab4-346b-4680-b3e1-a8c29b3933af
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 26, 2023
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
Products 1
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 Code63629-1027
Application NumberANDA090635
Product Classification
M
Marketing Category
C73584
G
Generic Name
METHADONE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateJune 13, 2022
FDA Product Classification
INGREDIENTS (4)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
METHADONE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 229809935B
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT