FDA-filed SPL labeling · retrieved through openFDA

Ampicillin and Sulbactam Injection

Ampicillin and sulbactam injection is a combination antibiotic used to treat bacterial infections of the skin, abdomen, and female reproductive tract.

Brand name Unasyn
Drug classes ⓘ Penicillin-class Antibacterial
Rx Form 1 Routes Intramuscular; Intravenous · Intravenous · Intramuscular, Intravenous
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 28 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveJul 10, 2026
Clinical labels in scope ⓘ28
AvailabilityRx
Earliest approval/marketing year ⓘ1991
FDA-listed product records ⓘ137
Boxed warningNone found in compared labels
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 25, 2026
⭐ Ampicillin and Sulbactam Injection at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Ampicillin and sulbactam injection is a broad-spectrum antibiotic combination given in a clinical setting to treat resistant bacterial infections of the skin, abdomen, and pelvis. It's generally well tolerated, but serious allergic reactions and severe skin reactions are real risks — make sure your care team knows your full allergy history before you receive it. Report any new rash, jaundice, or persistent diarrhea to your doctor promptly.

📖 Ampicillin and Sulbactam Injection: Patient Information Guide

A plain-language walkthrough of Ampicillin and Sulbactam Injection — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for▾

Ampicillin and sulbactam injection treats bacterial infections caused by organisms that are susceptible to this antibiotic combination, including bacteria that produce enzymes (beta-lactamases) to resist standard penicillins.

  • Skin and skin structure infections — caused by resistant strains of bacteria including Staphylococcus aureus, Escherichia coli, Klebsiella species, Proteus mirabilis, Bacteroides fragilis, Enterobacter species, and Acinetobacter calcoaceticus
  • Intra-abdominal infections — caused by resistant E. coli, Klebsiella species, Bacteroides species (including B. fragilis), and Enterobacter species
  • Gynecological infections — caused by resistant E. coli and Bacteroides species (including B. fragilis)
  • Mixed infections involving both ampicillin-susceptible organisms and resistant bacteria may be treated with this combination without adding a second antibiotic
  • For pediatric patients aged 1 year and older, Unasyn is given by intravenous infusion for these same types of infections; the IM route is not established in children
⚙️How it works▾

Ampicillin kills bacteria by interfering with the construction of their cell wall — a structure the bacteria need to survive. Without an intact wall, the bacteria break apart and die. Sulbactam doesn't do much killing on its own, but it plays a critical support role: it permanently disables beta-lactamases, the enzymes some bacteria produce to destroy ampicillin. By blocking those enzymes, sulbactam allows ampicillin to work against bacteria that would otherwise be resistant to it.

This combination gives the antibiotic a much broader reach — covering many gram-positive and gram-negative bacteria, including strains resistant to standard penicillins and cephalosporins.

💊How it's taken▾

Ampicillin and sulbactam injection is always given by a healthcare professional — never at home. It is administered either into a vein (IV) or into a muscle (IM) in adults.

  • It is typically given every 6 hours, though kidney problems may require less frequent dosing (every 8, 12, or 24 hours)
  • IV doses can be given as a slow injection or as a longer infusion, depending on the clinical situation
  • In pediatric patients 1 year or older, it is given only by IV infusion, in divided doses every 6 hours; IV treatment in children should generally not exceed 14 days
  • Children weighing 40 kg or more are dosed like adults

Always follow your prescriber's exact instructions. Do not adjust the schedule without checking with your care team first.

🤒Side effects — in detail▾

Most people tolerate ampicillin and sulbactam injection well. The most commonly reported side effects include:

  • Pain at the injection site (more common with IM injection)
  • Diarrhea
  • Rash
  • Nausea or vomiting
  • Itching
  • Headache
  • Vein irritation or inflammation (thrombophlebitis) at the IV site
  • Fatigue or feeling unwell

More serious reactions — including severe allergic reactions, life-threatening skin conditions, liver problems, and C. difficile diarrhea — can occur and require immediate medical attention. Tell your care team about any new symptoms right away.

⚠️Warnings & precautions▾
  • Severe allergic reactions: Life-threatening anaphylaxis (a sudden, whole-body allergic reaction) has been reported. People with a history of penicillin or cephalosporin allergy are at higher risk. Emergency treatment must be available.
  • Serious skin reactions: Rare but potentially fatal skin conditions including Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), and DRESS syndrome have occurred. Any new rash during treatment must be evaluated promptly — if it progresses, the drug must be stopped.
  • Liver toxicity: Hepatitis and cholestatic jaundice (liver inflammation that impairs bile flow) have been reported, rarely with fatal outcomes. Patients with liver disease should have their liver function monitored regularly during treatment.
  • Clostridioides difficile (C. difficile) infection: Like all antibiotics, this medication can disrupt normal gut bacteria and allow C. difficile to overgrow, causing severe diarrhea or colitis. This can occur during treatment or up to two months afterward.
  • Antibiotic resistance: This medication should only be used for proven or strongly suspected bacterial infections to help prevent the development of resistant bacteria.
🔀What it interacts with▾

Ampicillin and sulbactam injection can interact with a few other medications. Be sure your care team knows everything you take:

  • Probenecid (used for gout) — slows the kidneys' removal of ampicillin and sulbactam, increasing and prolonging blood levels of both drugs
  • Allopurinol (used for gout or high uric acid) — substantially increases the risk of developing a skin rash when taken at the same time as ampicillin
  • Aminoglycoside antibiotics (such as gentamicin or tobramycin) — must never be mixed in the same IV bag or syringe as ampicillin and sulbactam, because the ampicillin component can inactivate the aminoglycoside

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it▾
  • Do not use this medication if you have ever had a serious allergic reaction — such as anaphylaxis or Stevens-Johnson syndrome — to penicillins, cephalosporins, or other beta-lactam antibiotics
  • Do not use this medication if you have previously developed jaundice or liver problems specifically linked to ampicillin and sulbactam
  • Tell your doctor about any past antibiotic allergies or reactions to multiple allergens before starting treatment
  • Tell your doctor if you have kidney disease — the dosing schedule will need to be adjusted based on how well your kidneys work
  • Tell your doctor if you have liver disease — liver function should be checked regularly during treatment
  • Tell your doctor if you are pregnant, planning to become pregnant, or breastfeeding
  • In children aged 1 year and older, the IV route is used; the IM route has not been shown to be safe and effective in pediatric patients
🚑If you take too much▾

Taking too much of this medication can cause neurological side effects, including seizures (convulsions), especially if high levels build up in the fluid around the brain and spinal cord. If an overdose is suspected, seek emergency medical care immediately. The label notes that ampicillin — and likely sulbactam — can be partially removed from the blood by hemodialysis (a kidney-filtering procedure).

📡Pharmacodynamics — effects in the body▾

Ampicillin and sulbactam injection works by killing susceptible bacteria during their active growth phase — it disrupts the construction of the bacterial cell wall, which is essential for bacterial survival. Sulbactam permanently disables the beta-lactamase enzymes that would otherwise break down ampicillin, extending the antibiotic's reach to bacteria that carry resistance. The result is a broad-spectrum antibacterial effect covering many gram-positive and gram-negative bacteria, including resistant strains.

🔬Pharmacokinetics — how your body processes it▾

When given as a 15-minute IV infusion, peak blood levels of both ampicillin and sulbactam are reached immediately after the infusion is complete. After an IM injection, drug levels in the blood are lower but still therapeutic. Both drugs have a short half-life of about 1 hour in people with normal kidney function, meaning they are cleared fairly quickly. Approximately 75–85% of both drugs are eliminated unchanged through the urine within the first 8 hours, so kidney function has a direct impact on how long the drugs stay in the body and how often they need to be given.

📦How to store it▾

stored at 20° to 25°C (68° to 77°F) prior to reconstitution.

📄 Written from Ampicillin and Sulbactam Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Ampicillin and Sulbactam Injection — the kind of thing our pharmacy team would talk through with you at the counter.

What kinds of infections does this antibiotic treat? ▾
This injection is used to fight specific bacterial infections — mainly skin and wound infections, infections inside the abdomen, and gynecological (pelvic) infections. It's especially useful when the bacteria involved have developed resistance to standard penicillin-type antibiotics. Your doctor will order it only when tests (or strong clinical suspicion) point to bacteria that this drug can handle.
Why does this antibiotic have two drugs in it? ▾
Great question. Ampicillin is the main antibiotic that kills bacteria, but some bacteria make an enzyme called a beta-lactamase that destroys ampicillin before it can work. Sulbactam is added specifically to block that enzyme — think of it as a shield that protects the ampicillin and lets it do its job. Together, they cover a much wider range of bacteria than ampicillin alone could.
What side effects should I watch out for while I'm getting this? ▾
The most common ones are pain at the injection site, diarrhea, and a mild rash. These are usually manageable. What you should act on right away: any signs of a serious allergic reaction — hives, trouble breathing, or swelling of the face or throat — and any severe or spreading rash, which could signal a rare but serious skin reaction. Also let your team know if you develop yellowing of the skin or eyes, or if diarrhea becomes severe or bloody, even weeks after finishing the antibiotic.
I've had a penicillin allergy before. Is this safe for me? ▾
You need to tell your doctor or nurse about that before receiving this medication. Ampicillin is a penicillin-type antibiotic, and if you've had a serious reaction — like severe hives, swelling, or anaphylaxis — to penicillins or related antibiotics, you should not receive this drug. Your care team will review your allergy history carefully and choose a safe alternative if needed.
I'm also taking allopurinol for gout. Is that a problem? ▾
Yes, it's worth flagging. Taking allopurinol at the same time as ampicillin significantly raises the chance of developing a skin rash. Make sure your prescribing doctor knows you're on allopurinol so they can keep an eye out and decide if any adjustments are needed.
I have kidney disease — does that affect how I get this antibiotic? ▾
Yes, it does. Both ampicillin and sulbactam are cleared from your body mainly through the kidneys. If your kidneys aren't working at full capacity, the drugs stay in your system longer, so your doctor will space out the doses — giving them every 8, 12, or 24 hours instead of every 6 hours — to prevent the drug from building up too much. Make sure your kidney function is known to your care team before you start.
Is Ampicillin and Sulbactam Injection available over the counter? ▾
Ampicillin and Sulbactam Injection is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Ampicillin and Sulbactam Injection first available? ▾
Ampicillin and Sulbactam Injection has been available in the United States since at least 1991, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Ampicillin and Sulbactam Injection? ▾
Ampicillin and Sulbactam Injection is supplied by 23 manufacturers listed in the FDA NDC Directory, including Eugia US LLC, Meitheal Pharmaceuticals Inc., WG Critical Care, LLC.

💬 Answers drafted from Ampicillin and Sulbactam Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Ampicillin and Sulbactam Injection comes

Ampicillin and Sulbactam Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Injection

Into a muscle · Into a vein
Brands Unasyn
How this form is used
What it may be used for
  • Unasyn treats skin and skin structure infections caused by resistant bacteria including Staphylococcus aureus, E. coli, and Klebsiella
  • Unasyn treats intra-abdominal infections caused by bacteria such as E. coli, Klebsiella, Bacteroides, and Enterobacter
  • Unasyn treats gynecological infections caused by E. coli and Bacteroides species
Important instructions
  • Unasyn can be given into a vein (IV) as a slow injection over at least 10–15 minutes, or as a longer infusion over 15–30 minutes
  • Unasyn can also be given by deep intramuscular (IM) injection in adults; however, the IM route has not been established for pediatric patients
  • In pediatric patients 1 year of age or older, Unasyn is given by intravenous infusion in divided doses every 6 hours; IV treatment generally should not exceed 14 days
  • Patients with kidney impairment may receive Unasyn less frequently — dosing intervals are adjusted based on kidney function
Available strengths 18 strengths
Show 12 more strengths Show fewer strengths
133 FDA-listed product records ⓘ

📊 Ampicillin and Sulbactam Injection across the U.S. market

How Ampicillin and Sulbactam Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1
Dose forms ⓘ
23
Manufacturers
3
Brand names
137
FDA-listed product records ⓘ
1991
First marketed ⓘ

Also listed with the FDA, not a patient dose form: Powder (4) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Eugia US LLC15%
Meitheal Pharmaceuticals Inc.13%
WG Critical Care, LLC10%
Hikma Pharmaceuticals USA Inc.9%
Roerig9%
Sagent Pharmaceuticals6%
Other makers37%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Ampicillin and Sulbactam Injection is used

A general measure of how commonly Ampicillin and Sulbactam Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Ampicillin and Sulbactam Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

26,484
Medicaid prescriptions filled (Q1–Q4 2025)
$1.6M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Ampicillin and Sulbactam Injection prescribed? Of the 1,597 medications we measure, Ampicillin and Sulbactam Injection ranks #758 by Medicaid prescriptions — more than 53% of them.

Where Ampicillin and Sulbactam Injection ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Ampicillin and Sulbactam Injection product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 2000 mg / 1000 mg injection is the most-dispensed Ampicillin and Sulbactam Injection product — about 90% of these Medicaid prescriptions.

ampicillin 2000 MG / sulbactam 1000 MG Injection Most dispensed

23,745 Medicaid prescriptions (Q1–Q4 2025) 90% of Ampicillin and Sulbactam Injection prescriptions shown $1.4M gross reimbursement (before rebates) ≈ $60 per prescription (gross)

Summed across the 12 of 44 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1659598

ampicillin 100 MG/ML / sulbactam 50 MG/ML Injectable Solution

1,399 Medicaid prescriptions (Q1–Q4 2025) 5% of Ampicillin and Sulbactam Injection prescriptions shown $114,875 gross reimbursement (before rebates) ≈ $82 per prescription (gross)

Summed across the 7 of 23 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 240984

ampicillin 1000 MG / sulbactam 500 MG Injection

1,340 Medicaid prescriptions (Q1–Q4 2025) 5% of Ampicillin and Sulbactam Injection prescriptions shown $83,793 gross reimbursement (before rebates) ≈ $63 per prescription (gross)

Summed across the 5 of 40 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1659592

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Ampicillin and Sulbactam Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 24 of 107 listed Ampicillin and Sulbactam Injection NDCs with Medicaid activity.

🔍 Compare Ampicillin and Sulbactam Injection products

A representative set of FDA-listed product records for Ampicillin and Sulbactam Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 137 of 137 products — FDA National Drug Code Directory. See every product, package size and price: browse all 137 Ampicillin and Sulbactam Injection NDCs →

🏷️ Sold under these brand names

Unasyn

🏭 Manufacturers & labelers

Eugia US LLC 21 Meitheal Pharmaceuticals Inc. 18 WG Critical Care, LLC 14 Hikma Pharmaceuticals USA Inc. 13 Roerig 12 Sagent Pharmaceuticals 8 Hospira, Inc 6 Xellia Pharmaceuticals USA LLC 6 Piramal Critical Care Inc 6 Civica, Inc. 5 Armas Pharmaceuticals Inc. 5 Mylan Institutional LLC 4 NorthStar Rx, LLC 3 Onesource Specialty Pharma Limited 3 Avenacy, LLC 3 Methapharm, Inc. 2 Steriscience Specialties Private Limited 2 West-Ward Pharmaceuticals Corp. 1 ACS Dobfar S.p.A 1 Fresenius Kabi iPSUM S.r.l. 1 Aurobindo Pharma Limited 1 Medical Purchasing Solutions, LLC. 1 Eumedica Pharmaceuticals Industries Sociedad Limitada 1

RxNorm drug class

Ampicillin and Sulbactam Injection belongs to the beta Lactamase Inhibitor class.

Pharmacologic class beta Lactamase Inhibitor
Drug family (ATC) Beta-lactamase inhibitors
How it works beta Lactamase Inhibitors

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jul 10, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Ampicillin and Sulbactam Injection.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Ampicillin and Sulbactam Injection after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
28
NDC products indexed
137
Distinct labelers/manufacturers represented
23
Linked representative label ⓘ
Roerig
Linked label effective
Jul 10, 2026
Composite sections available
18
Linked SPL Set ID
155c7ec0-5862-404f-b1d0-f278f8a8bbda
Linked SPL Document ID
04da40ca-b337-4cac-a8d7-8dc9d5301c23
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 28 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Roerig is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.