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Active ingredient

Vardenafil

43 finished FDA listings contain Vardenafil as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
VARDENAFIL, VARDENAFIL HYDROCHLORIDE, VARDENAFIL HYDROCHLORIDE TRIHYDRATE
Dosage forms
Tablet, Tablet, Film Coated, Tablet, Orally Disintegrating
Routes
Oral
Manufacturers / labelers
11
Strengths listed
10 mg/1 · 11.85 mg/1 · 2.5 mg/1 · 20 mg/1 · 5 mg/1

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 306674

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
ANDA 091347TEVA PHARMS2012-05-035
ANDA 208960ZYDUS PHARMS2018-10-319
ANDA 209057CROSSMEDIKA SA2018-10-3113
ANDA 208324ALEMBIC2018-11-162
ANDA 204632MACLEODS PHARMS2019-10-224
ANDA 205988MACLEODS PHARMS2020-03-101
ANDA 214031ALEMBIC2020-08-049

Official labeling on DailyMed

Showing the 12 most recent of 21 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.