Quick answers
- What is Protonix I.V.?
- Protonix I.V. is a brand name of Pantoprazole sodium, a prescription medicine. The FDA NDC Directory lists 4 Protonix I.V. products in 1 strength and form.
- Who makes Protonix I.V.?
- Wyeth Pharms holds the FDA application for Protonix I.V. (NDA020988, approved March 22, 2001). 1 other company (repackagers or distributors) also list Protonix I.V. products.
- Is there a generic or store brand of Protonix I.V.?
- Yes. The FDA NDC Directory lists 7 other products with the same active ingredients, strength and form as a Protonix I.V. product, 7 of them generic. Ask your pharmacist whether one is right for you.
- Has Protonix I.V. been recalled?
- FDA enforcement reports list 1 recall of Protonix I.V. products; the newest started November 22, 2016. A recall usually concerns specific lots, not every product.
What Protonix I.V. is
Each Protonix I.V. 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.
Pantoprazole sodium · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| pantoprazole sodium 40 mg/10 mL injection, powder, for solution (intravenous) | Protonix I.V. | 7 products, 7 companies | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Pantoprazole sodium →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA020988 | Wyeth Pharms | March 22, 2001 | 4 |
Companies that list Protonix I.V.
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Protonix I.V. products.
- Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.2 products
- Cardinal Health 107, LLC2 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.
-
November 22, 2016 · Class III · Terminated · D-0516-2017
Subpotent Drug: Out of Specification (OOS) for potency at the 6-month stability time point.
PROTONIX I.V. (pantoprazole sodium) for Injection, Equivalent to 40 mg pantoprazole per vial, For I.V. infusion only, Rx Only, Distributed by Wyeth Pharmaceuticals Inc, A subsidiary of Pfizer Inc, Philadelphia, PA 19101, — Pfizer Inc.
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.