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These highlights do not include all the information needed to use HYDROCODONE BITARTRATE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for HYDROCODONE BITARTRATE EXTENDED-RELEASE CAPSULES . HYDROCODONE BITARTRATE extended-release capsules, for oral use, CII Initial U.S. Approval: 1943
Medication labelWhy this: Advisory · dailymed-prescription
Hydrocodone bitartrate extended-release capsules are indicated for the 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: Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, and because of the greater risks of overdose and death with extended-release/long-acting opioid formulations, [see Warnings and Precautions (5.1)], reserve hydrocodone bitartrate extended-release capsules for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Hydrocodone bitartrate extended-release capsules are not indicated as an as-needed (prn) analgesic.
- generic_name
- hydrocodone bitartrate
- product_names
- Hydrocodone Bitartrate
- ndc
- 47781-409, 47781-410, 47781-411, 47781-412, 47781-413, 47781-414, 47781-409-60, 47781-410-60, 47781-411-60, 47781-412-60, 47781-413-60, 47781-414-60
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en