Quick answers
- What is Unasyn?
- Unasyn is a brand name of Ampicillin sodium and sulbactam sodium, a prescription medicine. The FDA NDC Directory lists 3 Unasyn products in 3 strengths and forms.
- Who makes Unasyn?
- Pfizer holds the FDA application for Unasyn (NDA050608, approved December 31, 1986).
- Is there a generic or store brand of Unasyn?
- Yes. The FDA NDC Directory lists 26 other products with the same active ingredients, strength and form as a Unasyn product, 26 of them generic. Ask your pharmacist whether one is right for you.
- Has Unasyn been recalled?
- FDA enforcement reports list 1 recall of Unasyn products; the newest started May 29, 2020. A recall usually concerns specific lots, not every product.
What Unasyn is
Each Unasyn 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.
Ampicillin sodium and sulbactam sodium · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| ampicillin sodium 1 g · sulbactam sodium 0.5 g injection, powder, for solution (intramuscular, intravenous) | Unasyn | 11 products, 10 companies | DailyMed |
| ampicillin sodium 100 mg/mL · sulbactam sodium 50 mg/mL injection, powder, for solution (intramuscular, intravenous) | Unasyn | 3 products, 3 companies | DailyMed |
| ampicillin sodium 2 g · sulbactam sodium 1 g injection, powder, for solution (intramuscular, intravenous) | Unasyn | 12 products, 10 companies | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Ampicillin sodium and sulbactam sodium →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA050608 | Pfizer | December 31, 1986 | 3 |
Companies that list Unasyn
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Unasyn products.
- Roerig3 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 29, 2020 · Class II · Terminated · D-1306-2020
Presence of Particulate Matter: particulate matter identified after reconstitution.
Unasyn (ampicillin sodium/sulbacatam) for injection, 1.5 g* per vial, Rx Only, 10 vials/carton, Made in Italy Distributed by Roerig Division of Pfizer Inc. New York, NY 10017 vial NDC 0049-0013-81, carton NDC 0049-0013-8 — 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.