Drug
Who makes vardenafil hydrochloride?
8 companies list vardenafil hydrochloride as a human prescription drug. Forms: tablet; tablet, film coated. Routes: oral.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing vardenafil hydrochloride
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Alembic Pharmaceuticals LimitedIndia | tablet, film coated | ANDAANDA214031 | 8 | 7 |
| Bryant Ranch PrepackUnited States | tablet; tablet, film coated | ANDAANDA091347, ANDA209057, ANDA214031 | 6 | 1 |
| Teva Pharmaceutical Industries Ltd.Canada | tablet, film coated | ANDAANDA091347 | 4 | 6 |
| Macleods Pharmaceuticals LimitedIndia | tablet | ANDAANDA204632 | 4 | 5 |
| Lannett Company, LLCUnited States | tablet | ANDAANDA209057 | 4 | 1 |
| AvKARE | tablet | ANDAANDA209057 | 3 | 0 |
| Aphena Pharma Solutions - Tennessee, LLC | tablet | ANDAANDA209057 | 1 | 0 |
| Chartwell RX, LLC. | tablet | ANDAANDA209057 | 1 | 0 |
Bulk ingredient listings
- Willow Birch Pharma, LLCUnited States · 3 NDC
- Chromo Laboratories India Private LimitedIndia · 1 NDC
- Pharmaceutical Works POLPHARMA · 1 NDC
- RAKSHIT DRUGS PRIVATE LIMITEDIndia · 1 NDC
- SHOOLIN PHARMA CHEM LLPIndia · 1 NDC
- SMS Pharmaceuticals LimitedIndia · 1 NDC
- Zhejiang Bamboo Pharmaceuticals Co.,LtdChina · 1 NDC
Orange Book patents
2 unexpired patents list vardenafil hydrochloride as the active ingredient, expiring between Jul 2027 and Dec 2028. Application holder: BAYER HEALTHCARE PHARMACEUTICALS INC.
Enquiry
Common questions
- Who makes vardenafil hydrochloride?
- 8 companies list vardenafil hydrochloride as a human prescription drug in the openFDA NDC Directory, led by Alembic Pharmaceuticals Limited, Bryant Ranch Prepack, Teva Pharmaceutical Industries Ltd., Macleods Pharmaceuticals Limited, Lannett Company, LLC. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic vardenafil hydrochloride?
- 8 companies list vardenafil hydrochloride under an abbreviated new drug application (ANDA), the application type used for generics. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies vardenafil hydrochloride active ingredient?
- 7 companies list vardenafil hydrochloride as a bulk ingredient, including Willow Birch Pharma, LLC, Chromo Laboratories India Private Limited, Pharmaceutical Works POLPHARMA, RAKSHIT DRUGS PRIVATE LIMITED.