Quick answers
- What is Revatio?
- Revatio is a brand name of Sildenafil, a prescription medicine. The FDA NDC Directory lists 4 Revatio products in 3 strengths and forms.
- Who makes Revatio?
- Viatris holds the FDA application for Revatio (NDA021845, approved June 3, 2005). 1 other company (repackagers or distributors) also list Revatio products.
- Is there a generic or store brand of Revatio?
- Yes. The FDA NDC Directory lists 46 other products with the same active ingredients, strength and form as a Revatio product, 46 of them generic. Ask your pharmacist whether one is right for you.
- Has Revatio been recalled?
- No recall linked to Revatio products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Revatio is
Each Revatio product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Sildenafil · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| sildenafil citrate 0.8 mg/mL injection, solution (intravenous) | Revatio | None listed | DailyMed |
| sildenafil citrate 10 mg/mL powder, for suspension (oral) | Revatio | 8 products, 8 companies | DailyMed |
| sildenafil citrate 20 mg tablet, film coated (oral) | Revatio | 38 products, 21 companies | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Sildenafil →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
Companies that list Revatio
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Revatio products.
- Viatris Specialty LLC3 products
- Pfizer Laboratories Div Pfizer Inc1 product
Recalls
No recall linked to Revatio products (by their NDC code or label) appears in the FDA enforcement reports.
Sources
- 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 labeling (SPL, 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
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.