# Kuvan

NDC: 68135-482
Generic name: sapropterin dihydrochloride
Labeler / Manufacturer: BioMarin Pharmaceutical Inc.
Product type: HUMAN PRESCRIPTION DRUG
Marketing category: New Drug Application (innovator)
Dosage form: POWDER, FOR SOLUTION
Routes: ORAL
Marketing started: 20150527

FDA application: NDA205065

## Active ingredients

- SAPROPTERIN DIHYDROCHLORIDE: 500 mg/1

## Pharmacological class

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## External sources

- openFDA: https://api.fda.gov/drug/ndc.json?search=product_ndc:"68135-482"
- FDA NDC Directory: https://www.accessdata.fda.gov/scripts/cder/ndc/dsp_searchresult.cfm?p_ndc=68135-482
- DailyMed: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=af38711e-8873-4790-a92d-4d583e23fb89