Data / Drug companies / Vardenafil
Vardenafil: 6 companies and 12 products in the FDA NDC directory
Vardenafil is listed in the FDA National Drug Code Directory by 6 companies, with 12 products in commercial distribution. 12 of the products (100.0%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet, film coated; tablet, orally disintegrating; tablet, and the newest product started marketing on November 20, 2018.
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- Companies listing it
- 6
- Products
- 12
- Generic (ANDA) products
- 12 (100.0%)
- Application numbers
- 3
- Routes
- Oral
- openFDA record search
- api.fda.gov
Companies that list vardenafil
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Zydus Lifesciences Limited | 4 | tablet, film coated | Generic drugs (ANDA) | November 1, 2018 |
| Zydus Pharmaceuticals USA Inc. | 4 | tablet, film coated | Generic drugs (ANDA) | November 1, 2018 |
| Alembic Pharmaceuticals Inc. | 1 | tablet, orally disintegrating | Generic drugs (ANDA) | November 20, 2018 |
| Alembic Pharmaceuticals Limited | 1 | tablet, orally disintegrating | Generic drugs (ANDA) | November 20, 2018 |
| Aphena Pharma Solutions - Tennessee, LLC | 1 | tablet, film coated | Generic drugs (ANDA) | November 1, 2018 |
| Macleods Pharmaceuticals Limited | 1 | tablet | Generic drugs (ANDA) | October 26, 2018 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet, film coated | 9 | 75% |
| Tablet, orally disintegrating | 2 | 16.7% |
| Tablet | 1 | 8.3% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 12 | 100% |
Pharmacologic classes
| Class | Products |
|---|---|
| Phosphodiesterase 5 Inhibitor | 12 |
Updated November 6, 2026. Read from US Food and Drug Administration, National Drug Code Directory (openFDA). CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.