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These highlights do not include all the information needed to use SAPROPTERIN DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SAPROPTERIN DIHYDROCHLORIDE TABLETS. SAPROPTERIN DIHYDROCHLORIDE tablets, for oral useInitial U.S. Approval: 2007
Medication labelWhy this: Advisory · dailymed-prescription
Sapropterin dihydrochloride tablets are indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU). Sapropterin dihydrochloride tablets are to be used in conjunction with a Phe- restricted diet.
- generic_name
- sapropterin dihydrochloride
- product_names
- sapropterin dihydrochloride
- ndc
- 0054-0906, 0054-0906-23
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en