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
Approved
Approval ID
4a44bde6-c348-4316-b0e0-c24b407cb823
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 16, 2021
Manufacturers
FDA
VistaPharm, Inc.
DUNS: 116743084
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Methadone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66689-836
Application NumberANDA204166
Product Classification
M
Marketing Category
C73584
G
Generic Name
Methadone
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 16, 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