FDA NDC Directory · JSON-LD · Markdown

ZELVYSIA

NDC 73289-0071 · HUMAN PRESCRIPTION DRUG · POWDER, FOR SOLUTION

Generic namesapropterin dihydrochloride
Labeler / ManufacturerAucta Pharmaceuticals, Inc.
Marketing categoryAbbreviated NDA (generic) · App ANDA218645
Dosage form / routePOWDER, FOR SOLUTION · ORAL
Active ingredientsSAPROPTERIN DIHYDROCHLORIDE (500 mg/1)
Marketing started20250429
Package count1

External sources

Source: openFDA. Public-domain (CC0).