Drugplain

ZELVYSIA 500 mg/1

sapropterin dihydrochloride · POWDER, FOR SOLUTION · Aucta Pharmaceuticals, Inc.

No Recall History
Plain English

ZELVYSIA is a powder, for solution containing sapropterin dihydrochloride at 500 mg/1, taken oral. Manufactured by Aucta Pharmaceuticals, Inc..

Key Facts

Brand Name
ZELVYSIA
Generic Name
sapropterin dihydrochloride
NDC Code (Product)
73289-0071
Manufacturer
Aucta Pharmaceuticals, Inc.
Strength
500 mg/1
Dosage Form
POWDER, FOR SOLUTION
Route
ORAL
Marketing Status
Application #
ANDA218645
Marketing Start
04/29/2025

Recall History

No Recall History

Frequently Asked Questions

What is ZELVYSIA used for?

ZELVYSIA contains sapropterin dihydrochloride. It is a powder, for solution taken oral. Consult your doctor for specific uses.

Is ZELVYSIA a controlled substance?

ZELVYSIA is not classified as a controlled substance by the DEA.

What is the generic name for ZELVYSIA?

The generic name for ZELVYSIA is sapropterin dihydrochloride. There are 11 other brand versions of sapropterin dihydrochloride.

What is the NDC code for ZELVYSIA 500 mg/1?

The NDC (National Drug Code) for ZELVYSIA 500 mg/1 is 73289-0071, listed by Aucta Pharmaceuticals, Inc..