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These highlights do not include all the information needed to use OLPRUVA TMsafely and effectively. See full prescribing information for OLPRUVA. OLPRUVA (sodium phenylbutyrate) for oral suspension Initial U.S. Approval: 1996
Medication labelWhy this: Advisory · dailymed-prescription
OLPRUVA is indicated as adjunctive therapy to standard of care, which includes dietary management, for the chronic management of adult and pediatric patients weighing 20 kg or greater and with a body surface area (BSA) of 1.2 m 2or greater, 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 OLPRUVA. OLPRUVA 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
- brand_name
- Starch, Corn
- product_names
- sodium phenylbutyrate, Starch, Corn
- ndc
- 72542-200, 72542-300, 72542-400, 72542-500, 72542-600, 72542-667, 72542-002, 72542-003, 72542-367, 72542-200-02, 72542-200-09, 72542-002-01, 72542-000, 72542-000-01, 72542-300-02, 72542-300-09, 72542-003-01, 72542-400-02, 72542-400-18, 72542-500-02, 72542-500-18, 72542-600-02, 72542-600-18, 72542-667-02, 72542-667-18, 72542-367-01
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en