Zelvysia is a brand name of Sapropterin dihydrochloride, a prescription medicine. The FDA NDC Directory lists 2 Zelvysia products in 2 strengths and forms.

Aucta holds the FDA application for Zelvysia (ANDA218645, approved April 29, 2025).

Is there a generic or store brand of Zelvysia?

Yes. The FDA NDC Directory lists 14 other products with the same active ingredients, strength and form as a Zelvysia product, 12 of them generic. Ask your pharmacist whether one is right for you.

Zelvysia (Sapropterin dihydrochloride): maker, FDA approval and generic versions

Official data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the NDC Directory, Drugs@FDA, the official labels and recall reports; pharmacy costs come from the Centers for Medicare & Medicaid Services (CMS). Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or switch any medicine, including a switch between a brand and a generic.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

Quick answers

What is Zelvysia?: Zelvysia is a brand name of Sapropterin dihydrochloride, a prescription medicine. The FDA NDC Directory lists 2 Zelvysia products in 2 strengths and forms.
Who makes Zelvysia?: Aucta holds the FDA application for Zelvysia (ANDA218645, approved April 29, 2025).
Is there a generic or store brand of Zelvysia?: Yes. The FDA NDC Directory lists 14 other products with the same active ingredients, strength and form as a Zelvysia product, 12 of them generic. Ask your pharmacist whether one is right for you.
Has Zelvysia been recalled?: No recall linked to Zelvysia products (by their NDC code or label) appears in the FDA enforcement reports we use.

What Zelvysia is

Each Zelvysia product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.

Sapropterin dihydrochloride · prescription medicine

Strength and form	Product names	Same medicine, other names	Label
sapropterin dihydrochloride 100 mg powder, for solution (oral)	Zelvysia	7 products, 7 companies	DailyMed
sapropterin dihydrochloride 500 mg powder, for solution (oral)	Zelvysia	7 products, 7 companies	DailyMed

Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Sapropterin dihydrochloride →

FDA approval

ANDA: Abbreviated New Drug Application: how a generic version is approved.

FDA applications of Zelvysia products (Drugs@FDA)
Application	Holder	First approved	Products
ANDA218645	Aucta	April 29, 2025	2

Companies that list Zelvysia

The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Zelvysia products.

Aucta Pharmaceuticals, Inc.2 products

Recalls

No recall linked to Zelvysia products (by their NDC code or label) appears in the FDA enforcement reports.

Sources

NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026

Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.

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Zelvysia