Application Nr Approved Date Route Status External Links
NDA006383 1983-04-08 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage 1. For Detoxification Treatment Of Opioid Addiction (heroin Or Other Morphine-Like Drugs). 2. For Maintenance Treatment Of Opioid Addiction (heroin Or Other Morphine-Like Drugs), In Conjunction With Appropriate Social And Medical Services. Conditions For Distribution And Use Of Methadone Products For The Treatment Of Opioid Addiction Code Of Federal Regulations, Title 42, Sec 8. Methadone Products When Used For The Treatment Of Opioid Addiction In Detoxification Or Maintenance Programs, Shall Be Dispensed Only By Opioid Treatment Programs (and Agencies, Practitioners Or Institutions By Formal Agreement With The Program Sponsor) Certified By The Substance Abuse And Mental Health Services Administration And Approved By The Designated State Authority. Certified Treatment Programs Shall Dispense And Use Methadone In Oral Form Only And According To The Treatment Requirements Stipulated In The Federal Opioid Treatment Standards (42 Cfr 8.12). See Below For Important Regulatory Exceptions To The General Requirement For Certification To Provide Opioid Agonist Treatment. Failure To Abide By The Requirements In These Regulations May Result In Criminal Prosecution, Seizure Of The Drug Supply, Revocation Of The Program Approval, And Injunction Precluding Operation Of The Program. Regulatory Exceptions To The General Requirement For Certification To Provide Opioid Agonist Treatment During Inpatient Care, When The Patient Was Admitted For Any Condition Other Than Concurrent Opioid Addiction (pursuant To 21 Cfr 1306.07(c)), To Facilitate The Treatment Of The Primary Admitting Diagnosis. During An Emergency Period Of No Longer Than 3 Days While Definitive Care For The Addiction Is Being Sought In An Appropriately Licensed Facility (pursuant To 21 Cfr 1306.07(b)).

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Methadone Hydrochloride METHADONE HYDROCHLORIDE ZINC1530706

Comments