Prescription medicine
Ampicillin and sulbactam Brand names: Unasyn
Ampicillin and sulbactam (Unasyn) is a prescription medicine with an FDA approval on record since 1986. FDA's NDC Directory lists it from 12 generic labelers.
- Generic listed
Check it at the source: the ampicillin and sulbactam FDA label on DailyMed (effective July 10, 2026, Roerig); the NDA 50608 record on Drugs@FDA; every ampicillin and sulbactam label on DailyMed.
Highlights of the record
FDA label of July 10, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageUNASYN is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below.
Forms and strengths
- 1 g / 0.5 g
- 1 g / 2 g
- 1 g/1.5g / 0.5 g/1.5g
- 2 g / 1 g
- 2 g/3g / 1 g/3g
- 10 g / 5 g
- 10 g/15g / 5 g/15g
- 100 mg/ml / 50 mg/ml
Injection (powder) for solution.
On the market
- Earliest approval on file
- December 31, 1986 Unasyn, Pfizer; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 24 first November 25, 1988; 14 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 13 of which 12 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 17 since 2018 2 Class I among all firms' recalls; latest May 15, 2023
- FAERS reports
- 2,564 through July 30, 2026
What is ampicillin and sulbactam used for?
From the label: indications and usageUNASYN is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below. Skin and Skin Structure Infections caused by beta-lactamase producing strains of Staphylococcus aureus, Escherichia coli, Efficacy for this organism in this organ system was studied in fewer than 10 infections. Klebsiella spp. (including K. pneumoniae ), Proteus mirabilis, Bacteroides fragilis, Enterobacter spp., and Acinetobacter calcoaceticus. NOTE: For information on use in pediatric patients (see PRECAUTIONS–Pediatric Use and CLINICAL STUDIES sections). […]
Conditions named in the indications of ampicillin and sulbactam's FDA labels, with every medicine labeled for each:
From other ampicillin and sulbactam labelsBacterial infections: INDICATIONS AND USAGE UNASYN is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below.
FDA pharmacologic class: Penicillin-class Antibacterial and beta Lactamase Inhibitor.
Source: FDA drug label (UNASYN), NDA050608 (Pfizer), as published by Roerig, effective July 10, 2026 (SPL set 155c7ec0-5862-404f-b1d0-f278f8a8bbda), via openFDA; the full label on DailyMed
Is there a generic for ampicillin and sulbactam (Unasyn)?
The FDA approved the first generic ampicillin and sulbactam on November 25, 1988. 24 generic applications are approved; 14 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists ampicillin and sulbactam from 12 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1986 earliest approval on file
- 1988 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has ampicillin and sulbactam been recalled?
The FDA's Enforcement Report lists 17 recalls naming ampicillin and sulbactam since 2018: 2 Class I (the most serious), 15 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| May 15, 2023 | Class II | Astral SteriTech Private Ltd. | Lack of Assurance of Sterility |
| May 29, 2020 | Class II | Pfizer Inc. | Presence of Particulate Matter: particulate matter identified after reconstitution. |
| May 1, 2018 | Class I | AuroMedics Pharma LLC | Presence of Particulate Matter: confirmed customer report of the presence of visible particulate matter believed to be red rubber particles from the … |
| January 2, 2018 | Class I | Aurobindo Pharma Ltd. | Presence of Particulate Matter: A confirmed customer report was received for the presence of visible particulate matter, confirmed as glass, within a single … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the ampicillin and sulbactam label say about other medicines?
The ampicillin and sulbactam label names 2 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Allopurinol | drug interactions | The concurrent administration of allopurinol and ampicillin increases substantially the incidence of rashes in patients receiving both drugs as compared to patients receiving ampicillin alone. |
| Probenecid | drug interactions | Drug Interactions Probenecid decreases the renal tubular secretion of ampicillin and sulbactam. |
Source: FDA drug label (UNASYN), NDA050608 (Pfizer), as published by Roerig, effective July 10, 2026 (SPL set 155c7ec0-5862-404f-b1d0-f278f8a8bbda), via openFDA; the full label on DailyMed
What do FAERS reports show for ampicillin and sulbactam?
The FDA Adverse Event Reporting System holds 2,564 reports that list ampicillin and sulbactam among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 522 are coded as a death and 1,375 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other penicillins
- the pharmacologic class, with prices and generics
- Ampicillin and sulbactam side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other