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
1a536622-dda3-41af-ab08-28e7c1bc9300
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 26, 2023
Manufacturers
FDA
XLCare Pharmaceuticals, Inc
DUNS: 080991142
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 Code72865-121
Application NumberANDA211228
Product Classification
M
Marketing Category
C73584
G
Generic Name
Methadone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 26, 2023
FDA Product Classification
INGREDIENTS (4)
METHADONE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 229809935B
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT