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These highlights do not include all the information needed to use PHEBURANE safely and effectively. See full prescribing information for PHEBURANE. PHEBURANE® (sodium phenylbutyrate) oral pellets Initial U.S. Approval: 1996
Medication labelWhy this: Advisory · dailymed-prescription
PHEBURANE is indicated as adjunctive therapy to standard of care, which includes dietary management, for the chronic management of adult and pediatric patients with urea cycle disorders (UCDs), involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC) or argininosuccinic acid synthetase (AS). Limitations of Use Episodes of acute hyperammonemia may occur in patients while on PHEBURANE. PHEBURANE is not indicated for the treatment of acute hyperammonemia, which can be a life-threatening medical emergency that requires rapid acting interventions to reduce plasma ammonia levels.
- generic_name
- sodium phenylbutyrate
- product_names
- Sodium phenylbutyrate
- ndc
- 71770-210, 71770-210-10, 71770-200, 71770-200-10
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en