# ZELVYSIA

NDC: 73289-0071
Generic name: sapropterin dihydrochloride
Labeler / Manufacturer: Aucta Pharmaceuticals, Inc.
Product type: HUMAN PRESCRIPTION DRUG
Marketing category: Abbreviated NDA (generic)
Dosage form: POWDER, FOR SOLUTION
Routes: ORAL
Marketing started: 20250429

FDA application: ANDA218645

## 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:"73289-0071"
- FDA NDC Directory: https://www.accessdata.fda.gov/scripts/cder/ndc/dsp_searchresult.cfm?p_ndc=73289-0071
- DailyMed: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=8de84882-dd24-46f2-8416-5e492d4275d1