Methadone Hydrochloride
METHADONE HYDROCHLORIDE INJECTION, USP 200 mg/20 mL (10 mg/mL) Rx only
Approved
Approval ID
092d78eb-6423-495c-bf0d-e6532bea7138
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 1, 2023
Manufacturers
FDA
Mylan Institutional LLC
DUNS: 790384502
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 Code67457-217
Application NumberNDA021624
Product Classification
M
Marketing Category
C73594
G
Generic Name
Methadone Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS
Effective DateDecember 1, 2016
FDA Product Classification
INGREDIENTS (5)
Methadone HydrochlorideActive
Quantity: 10 mg in 1 mL
Code: 229809935B
Classification: ACTIB
Sodium chlorideInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
Hydrochloric AcidInactive
Code: QTT17582CB
Classification: IACT
ChlorobutanolInactive
Code: HM4YQM8WRC
Classification: IACT
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT