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These highlights do not include all the information needed to use SAPROPTERIN DIHYDROCHLORIDE POWDER FOR ORAL SOLUTION safely and effectively. See full prescribing information for SAPROPTERIN DIHYDROCHLORIDE POWDER FOR ORAL SOLUTION. SAPROPTERIN DIHYDROCHLORIDE powder for oral solution Initial U.S. Approval: 2007
Medication labelWhy this: Advisory · dailymed-prescription
Sapropterin dihydrochloride powder for oral solution is 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 powder for oral solution is to be used in conjunction with a Phe- restricted diet.
- generic_name
- sapropterin dihydrochloride
- product_names
- Sapropterin Dihydrochloride
- ndc
- 52817-850, 52817-851, 52817-850-30, 52817-850-01, 52817-851-30, 52817-851-01
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en