Methadone Hydrochloride
These highlights do not include all the information needed to use Methadone Hydrochloride Tablets, USP safely and effectively. See full prescribing information for Methadone Hydrochloride Tablets, USP. Methadone Hydrochloride Tablets, USP, for oral use CII Initial U.S. Approval: 1947
Approved
Approval ID
cc79daec-2430-4d17-a37d-5a7ff5bfd883
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 27, 2021
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 Code71335-0493
Application NumberANDA203502
Product Classification
M
Marketing Category
C73584
G
Generic Name
Methadone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMarch 4, 2021
FDA Product Classification
INGREDIENTS (6)
METHADONE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: 229809935B
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT