Is Vardenafil Hydrochloride Trihydrate FDA approved?

Vardenafil Hydrochloride Trihydrate holds no registered establishment of its own; 1 drug product is listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Vardenafil Hydrochloride Trihydrate make?

1 product is listed under Vardenafil Hydrochloride Trihydrate in the openFDA NDC Directory, most often as powder. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Vardenafil Hydrochloride Trihydrate

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 0
Active NDC listings: 1
Live patents: 0
Countries: 0

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Marketed products

Brand	Generic name	Form / route	NDC
-	Vardenafil Hydrochloride Trihydrate	powder	33342-604BULK INGREDIENT

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Other companies listing vardenafil hydrochloride trihydrate

Macleods Pharmaceuticals Limited5 sites · 390 NDC
LETCO MEDICAL, LLC1 site · 224 NDC
APISTER LIFESCIENCES PRIVATE LIMITED1 site · 32 NDC
Cutyx Research LLP1 site · 14 NDC

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Common questions

Is Vardenafil Hydrochloride Trihydrate FDA approved?: Vardenafil Hydrochloride Trihydrate holds no registered establishment of its own; 1 drug product is listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Vardenafil Hydrochloride Trihydrate make?: 1 product is listed under Vardenafil Hydrochloride Trihydrate in the openFDA NDC Directory, most often as powder. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.