NDC 52817-850

Sapropterin Dihydrochloride 100 mg powder, for solution

On the label: TruPharma LLC..

United States: 1

Where it's made

FactoryWhereRoleLast FDA inspection
Mikart, LLCAtlanta, GA, United StatesMakes it, packages it and labels it No problems foundAug 10, 2026 · 15 inspections

Product details

Generic drug
Sapropterin: every company that makes it
Form
powder, for solution, oral
Strength
100 mg
Approval
ANDA ANDA216432
On the market since
Jan 30, 2026
Package NDCs
52817-850-01 52817-850-30
Official label
DailyMed (National Library of Medicine), updated Feb 18, 2026

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