Methadone Hydrochloride
These highlights do not include all the information needed to use METHADONE HYDROCHLORIDE TABLETS for oral suspension safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE TABLETS for oral suspension. METHADONE HYDROCHLORIDE tablets for oral suspension, USP CII Initial U.S. Approval: 1947
Approved
Approval ID
c54baaee-8ea4-45f5-a5c8-bb84cf86832f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 12, 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 Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66689-898
Application NumberANDA075082
Product Classification
M
Marketing Category
C73584
G
Generic Name
Methadone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 8, 2021
FDA Product Classification
INGREDIENTS (5)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
METHADONE HYDROCHLORIDEActive
Quantity: 40 mg in 1 1
Code: 229809935B
Classification: ACTIB