Quick answers
- What is Vasotec?
- Vasotec is a brand name of Enalapril maleate, a prescription medicine. The FDA NDC Directory lists 4 Vasotec products in 4 strengths and forms.
- Who makes Vasotec?
- Bausch holds the FDA application for Vasotec (NDA018998, approved December 24, 1985).
- Is there a generic or store brand of Vasotec?
- Yes. The FDA NDC Directory lists 95 other products with the same active ingredients, strength and form as a Vasotec product, 95 of them generic. Ask your pharmacist whether one is right for you.
- Has Vasotec been recalled?
- FDA enforcement reports list 1 recall of Vasotec products; the newest started May 21, 2014. A recall usually concerns specific lots, not every product.
What Vasotec is
Each Vasotec 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.
Enalapril maleate · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| enalapril maleate 10 mg tablet (oral) | Vasotec | 26 products, 21 companies | DailyMed |
| enalapril maleate 2.5 mg tablet (oral) | Vasotec | 16 products, 14 companies | DailyMed |
| enalapril maleate 20 mg tablet (oral) | Vasotec | 28 products, 21 companies | DailyMed |
| enalapril maleate 5 mg tablet (oral) | Vasotec | 25 products, 18 companies | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Enalapril maleate →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA018998 | Bausch | December 24, 1985 | 4 |
Companies that list Vasotec
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Vasotec products.
- Bausch Health US LLC4 products
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
May 21, 2014 · Class III · Terminated · D-0019-2015
Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package insert.
Vasotec (enalapril maleate) tablets, RX only, Manufactured by Valeant Pharmaceuticals International, Inc., Steinbach, MD R5G 1Z7 Canada 2.5 mg 90 ct - NDC 0187-0140-90 5 mg 30 ct - NDC 0187-0141-30 5 mg 90 ct - NDC 0187- — Valeant Pharmaceuticals North America LLC
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.