methadone hydrochloride
Drug Details
- Generic Name
- methadone hydrochloride
- Brand Names
- METHADOSE, Methadone Hydrocloride dye-free, sugar-free, unflavored, METHADOSE SUGAR-FREE
- Application Number
- NDA017116
- Sponsor
- SpecGx LLC
- NDC Codes
- 6
- Dosage Forms
- CONCENTRATE
- Routes
- ORAL
- Active Ingredients
- METHADONE HYDROCHLORIDE
Indications and Usage
1 INDICATIONS AND USAGE Methadone hydrochloride tablets for oral suspension contain methadone, an opioid agonist indicated for the: Detoxification treatment of opioid addiction (heroin or other morphine-like drugs). Maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services. Limitations of Use Methadone products used for the treatment of opioid addiction in detoxification or maintenance programs are subject to the conditions for distribution and use required under 42 CFR 8.12 [see Dosage and Administration ( 2.1 )] . Methadone hydrochloride tablets for oral suspension are an opioid agonist indicated for the: Detoxification treatment of opioid addiction (heroin or other morphine-like drugs) ( 1 ) Maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services. ( 1 ) Limitations of Use Methadone products used for the treatment of opioid addiction in detoxification or maintenance programs are subject to the conditions for distribution and use required under 21 CFR, Title 42, Sec 8. ( 1 , 2.1 )