Quick answers
- What is Nitrostat?
- Nitrostat is a brand name of Nitroglycerin, a prescription medicine. The FDA NDC Directory lists 6 Nitrostat products in 3 strengths and forms.
- Who makes Nitrostat?
- Viatris holds the FDA application for Nitrostat (NDA021134, approved May 1, 2000). 3 other companies (repackagers or distributors) also list Nitrostat products.
- Is there a generic or store brand of Nitrostat?
- Yes. The FDA NDC Directory lists 52 other products with the same active ingredients, strength and form as a Nitrostat product, 52 of them generic. Ask your pharmacist whether one is right for you.
- Has Nitrostat been recalled?
- No recall linked to Nitrostat products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Nitrostat is
Each Nitrostat 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.
Nitroglycerin · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| nitroglycerin 0.3 mg tablet (sublingual) | Nitrostat | 9 products, 9 companies | DailyMed |
| nitroglycerin 0.4 mg tablet (sublingual) | Nitrostat | 34 products, 20 companies | DailyMed |
| nitroglycerin 0.6 mg tablet (sublingual) | Nitrostat | 9 products, 9 companies | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Nitroglycerin →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA021134 | Viatris | May 1, 2000 | 6 |
Companies that list Nitrostat
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Nitrostat products.
- Viatris Specialty LLC3 products
- Proficient Rx LP1 product
- Henry Schein, Inc.1 product
- A-S Medication Solutions1 product
Recalls
No recall linked to Nitrostat 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.