Quick answers
- What is Vardenafil used for?
- The FDA-approved label (Vardenafil Hydrochloride, Bryant Ranch Prepack, August 27, 2026) says: “Vardenafil hydrochloride tablets are indicated for the treatment of erectile dysfunction. Vardenafil hydrochloride tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Vardenafil have a boxed warning?
- No. None of the 21 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Vardenafil?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Vardenafil been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Vardenafil?
- 11 companies list prescription products of Vardenafil in the FDA NDC Directory, including Bryant Ranch Prepack, Alembic Pharmaceuticals Inc. and Alembic Pharmaceuticals Limited.
What Vardenafil is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Vardenafil hydrochloride tablets are indicated for the treatment of erectile dysfunction. Vardenafil hydrochloride tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction.
— FDA label: Vardenafil Hydrochloride, Bryant Ranch Prepack, effective August 27, 2026. Read the full label on DailyMed →
The FDA has 21 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 21 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Tablet · Tablet, orally disintegrating |
|---|---|
| Route | Oral |
| Prescription products | 43 in the FDA NDC Directory |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| vardenafil 10 mg tablet | Generic | $4.13 per tablet |
| vardenafil 20 mg tablet | Generic | $2.63 per tablet |
| vardenafil 5 mg tablet | Generic | $7.10 per tablet |
| vardenafil hydrochloride 10 mg tablet | Generic | $4.13 per tablet |
| vardenafil hydrochloride 10 mg tablet, film coated | Generic | $4.13 per tablet |
| vardenafil hydrochloride 20 mg tablet | Generic | $2.63 per tablet |
| vardenafil hydrochloride 20 mg tablet, film coated | Generic | $2.63 per tablet |
| vardenafil hydrochloride 5 mg tablet | Generic | $7.10 per tablet |
| vardenafil hydrochloride 5 mg tablet, film coated | Generic | $7.10 per tablet |
| vardenafil hydrochloride trihydrate 10 mg tablet, film coated | Generic | $4.13 per tablet |
| vardenafil hydrochloride trihydrate 10 mg tablet, orally disintegrating | Generic | $21.76 per tablet |
| vardenafil hydrochloride trihydrate 11.85 mg tablet | Generic | $21.76 per tablet |
| vardenafil hydrochloride trihydrate 20 mg tablet, film coated | Generic | $2.63 per tablet |
| vardenafil hydrochloride trihydrate 5 mg tablet, film coated | Generic | $7.10 per tablet |
NADAC list of November 4, 2026; these prices took effect between March 18, 2026 and October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bryant Ranch Prepack6 products
- Alembic Pharmaceuticals Inc.5 products
- Alembic Pharmaceuticals Limited5 products
- Macleods Pharmaceuticals Limited5 products
- Lannett Company, Inc.4 products
- Teva Pharmaceuticals USA, Inc.4 products
- Zydus Lifesciences Limited4 products
- Zydus Pharmaceuticals USA Inc.4 products
- AvKARE3 products
- Aphena Pharma Solutions - Tennessee, LLC2 products
- Chartwell RX, LLC1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (7)
- ANDA091347Teva Pharms · May 3, 2012
- ANDA208960Zydus Pharms · October 31, 2018
- ANDA209057Crossmedika SA · October 31, 2018
- ANDA208324Alembic · November 16, 2018
- ANDA204632Macleods Pharms · October 22, 2019
- ANDA205988Macleods Pharms · March 10, 2020
- ANDA214031Alembic · August 4, 2020
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Vardenafil Hydrochloride, Bryant Ranch Prepack, effective August 27, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →