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These highlights do not include all the information needed to use METHADONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE TABLETS. METHADONE HYDROCHLORIDE tablets, for oral use CIIInitial U.S. Approval: 1947
Medication labelWhy this: Advisory · dailymed-prescription
Methadone Hydrochloride Tablets are indicated for the: 1. Management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. Limitations of Use 2. Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see Warnings and Precautions ( 5.1 )] , reserve Methadone Hydrochloride Tablets for use in patients for whom alternative analgesic treatment options (e.g., non-opioid analgesics or opioid combination products): o Have not been tolerated or are not expected to be tolerated, o Have not provided adequate analgesia or are not expected to provide adequate analgesia. 3. Methadone Hydrochloride Tablets are not indicated as an as-needed (prn) analgesic. 4.Detoxification treatment of opioid addiction (heroin or other morphine-like drugs). 5.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)].
- generic_name
- methadone hydrochloride
- product_names
- METHADONE HYDROCHLORIDE
- ndc
- 0904-7417, 0054-0710, 0904-7417-61
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en