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.

NDC Product Code67457-217

Application NumberNDA021624

Marketing CategoryC73594

Route of AdministrationINTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS

Effective DateDecember 1, 2016

Generic NameMethadone Hydrochloride

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