Amoxicillin / Clavulanate
Amoxicillin/clavulanate is a combination antibiotic used to treat bacterial infections of the respiratory tract, ears, sinuses, skin, and urinary tract in adults and children.
🧬 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 201 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 →
📖 Amoxicillin / Clavulanate: Patient Information Guide
A plain-language walkthrough of Amoxicillin / Clavulanate — 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▾
Amoxicillin/clavulanate is a combination antibiotic used to treat a range of bacterial infections across several formulations in both adults and children. Not every form is approved for every use — see product-specific notes below.
- Lower respiratory tract infections — tablets, chewable tablets, and oral suspensions (including Augmentin)
- Acute bacterial otitis media (ear infections) — tablets, chewable tablets, and oral suspensions (including Augmentin); Augmentin ES-600 and similar 600 mg/42.9 mg per 5 mL suspensions are specifically for recurrent or persistent ear infections in children aged 3 months to 12 years weighing ≤40 kg with certain risk factors (recent antibiotic use, age ≤2 years, or daycare attendance)
- Sinusitis — tablets, chewable tablets, and oral suspensions (including Augmentin); Amoxicillin and Clavulanate Potassium Extended-Release Tablets treat acute bacterial sinusitis in adults and pediatric patients ≥40 kg who can swallow tablets
- Community-acquired pneumonia — Amoxicillin and Clavulanate Potassium Extended-Release Tablets only, for adults and pediatric patients ≥40 kg who can swallow tablets
- Skin and skin structure infections — tablets, chewable tablets, and oral suspensions (including Augmentin)
- Urinary tract infections — tablets, chewable tablets, and oral suspensions (including Augmentin)
⚙️How it works▾
Amoxicillin is a penicillin-class antibiotic that kills bacteria by interfering with their ability to build a stable cell wall — without a working cell wall, bacteria cannot survive. Clavulanate potassium is a beta-lactamase inhibitor: it blocks the enzyme (beta-lactamase) that some bacteria use to break down and inactivate amoxicillin, restoring amoxicillin's ability to fight those resistant bacteria.
The antibacterial effect depends on keeping amoxicillin levels above the bacteria's minimum inhibitory concentration (the lowest drug level needed to stop bacterial growth) for as much of the dosing period as possible. This is why the timing and frequency of doses matters.
💊How it's taken▾
Amoxicillin/clavulanate is taken by mouth in tablet, chewable tablet, or liquid suspension form. It is generally dosed two or three times daily depending on the specific product and condition being treated — follow your prescriber's schedule exactly. Taking each dose at the start of a meal is strongly recommended: food improves absorption of the clavulanate component and helps prevent stomach upset.
- Tablets and suspensions can technically be taken without food, but starting a meal before each dose is preferred
- Augmentin ES-600 and similar high-dose suspensions should always be taken at the start of a meal
- Finish the full prescribed course even if you feel better — stopping early can allow the infection to return or bacteria to develop resistance
🤒Side effects — in detail▾
The most commonly reported side effects include:
- Diarrhea or loose stools (most common — more likely with higher doses)
- Nausea
- Vomiting
- Skin rash or hives
- Vaginitis
Serious reactions are less common but require immediate medical attention: severe allergic reactions (including anaphylaxis), dangerous skin reactions like Stevens-Johnson syndrome, liver problems (jaundice, hepatitis), and a gut infection called C. difficile — which can cause severe, persistent diarrhea and may appear weeks after finishing antibiotics.
⚠️Warnings & precautions▾
- Serious allergic reactions: Anaphylaxis (a life-threatening whole-body allergic reaction) has occurred. Risk is higher in people with a penicillin or cephalosporin allergy. Stop the medication and get emergency help immediately if you have trouble breathing, swelling, or a sudden drop in blood pressure.
- Severe skin reactions: Rarely, this drug can cause Stevens-Johnson syndrome, toxic epidermal necrolysis, or DRESS — all serious, potentially life-threatening skin conditions. Stop taking the drug and call your doctor if a rash starts to blister, peel, or spread.
- Liver problems: Hepatitis and cholestatic jaundice (bile backup causing yellowing of the skin) have been reported — rarely fatal. Watch for yellow skin or eyes, dark urine, or unusual abdominal pain.
- C. difficile diarrhea (CDAD): Antibiotics can disrupt normal gut bacteria and allow C. difficile to overgrow, causing severe diarrhea or colitis — even weeks after finishing the course. Seek care for any persistent or bloody diarrhea.
- Mononucleosis: A very high proportion of patients with mono who take amoxicillin-containing products develop a skin rash. Do not use this medication if you have mono.
- Phenylketonuria (PKU): Chewable tablets and some oral suspensions contain phenylalanine and must be used cautiously in people with PKU.
🔀What it interacts with▾
Amoxicillin/clavulanate can interact with several medications — tell your prescriber and pharmacist about everything you take:
- Probenecid (gout medication): raises amoxicillin blood levels; co-use is not recommended
- Oral anticoagulants (blood thinners like warfarin): can increase bleeding risk by prolonging clotting time; more frequent INR monitoring and possible dose adjustment may be needed
- Allopurinol (gout medication): substantially increases the risk of skin rash when combined with amoxicillin
- Oral contraceptives (birth control pills): this antibiotic may reduce their effectiveness by affecting gut bacteria that help recycle estrogen — consider a backup contraceptive method
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▾
- Tell your doctor if you have ever had a serious allergic reaction (especially anaphylaxis or a severe skin reaction) to penicillin, cephalosporins, or any beta-lactam antibiotic
- Do not take this medication if you have previously had jaundice or liver problems caused specifically by amoxicillin/clavulanate
- Inform your doctor if you have mononucleosis (mono) — use should be avoided due to high risk of rash
- Tell your doctor if you have kidney disease — dose adjustment is recommended for severe kidney impairment
- Tell your doctor if you have liver disease — regular liver function monitoring is recommended during treatment
- If you are pregnant or breastfeeding, discuss risks and benefits with your prescriber before use
- People with phenylketonuria (PKU) should note that some chewable tablets and oral suspensions contain phenylalanine
🚑If you take too much▾
Taking too much amoxicillin/clavulanate most commonly causes stomach and abdominal pain, vomiting, and diarrhea; rash, hyperactivity, or drowsiness have also been reported in some patients. In rare cases, overdose has been associated with crystalluria (crystals in the urine) and kidney problems, so staying well-hydrated is important. If you suspect an overdose, stop the medication and contact a poison control center or seek emergency care right away.
📡Pharmacodynamics — effects in the body▾
The antibacterial effect of amoxicillin/clavulanate depends on how long amoxicillin blood levels remain above the minimum concentration needed to stop bacterial growth — a concept called %fT>MIC (percentage of time the free drug exceeds the minimum inhibitory concentration). Clavulanate does not directly kill bacteria; instead, it protects amoxicillin by blocking beta-lactamase enzymes that certain bacteria produce to destroy it, effectively extending amoxicillin's reach to bacteria that would otherwise be resistant.
🔬Pharmacokinetics — how your body processes it▾
After an oral dose, both amoxicillin and clavulanate are absorbed from the gut — peak blood levels occur roughly 1 to 1.5 hours after dosing. Neither component binds tightly to blood proteins (amoxicillin is about 18% bound, clavulanate about 25%), and amoxicillin spreads readily into most body tissues and fluids, though not into the brain or spinal fluid. Amoxicillin has a half-life of about 1.3 hours and clavulanate about 1 hour, both cleared mainly by the kidneys — 50–70% of amoxicillin and 25–40% of clavulanate are excreted unchanged in urine within the first 6 hours. Taking the medication with food enhances clavulanate absorption, though it has little effect on amoxicillin levels.
📦How to store it▾
Dispense in tight container . Store tablets and dry powder at or below 25°C (77°F). Store reconstituted suspension under refrigeration.
📄 Written from Amoxicillin / Clavulanate’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 Amoxicillin / Clavulanate — the kind of thing our pharmacy team would talk through with you at the counter.
What infections does amoxicillin/clavulanate actually treat? ▾
Should I take this with food or on an empty stomach? ▾
I'm getting a lot of diarrhea — is that normal, and when should I be worried? ▾
What allergy symptoms should I watch for, and how serious can they be? ▾
Can this antibiotic affect my birth control pills? ▾
Do I really need to finish the full course even if I feel better? ▾
Is Amoxicillin / Clavulanate available over the counter? ▾
When was Amoxicillin / Clavulanate first available? ▾
Who makes Amoxicillin / Clavulanate? ▾
💬 Answers drafted from Amoxicillin / Clavulanate’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 Amoxicillin / Clavulanate comes
Amoxicillin / Clavulanate is available in 4 forms. 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.
Tablet
How this form is used
- Amoxicillin and Clavulanate Potassium Tablets treat lower respiratory tract infections, acute bacterial otitis media, sinusitis, skin and skin structure infections, and urinary tract infections in adults and pediatric patients
- Indicated only when bacteria are confirmed or suspected to produce beta-lactamase enzymes
- Amoxicillin and Clavulanate Potassium Tablets may be taken with or without food, but taking them at the start of a meal improves clavulanate absorption and reduces stomach upset
- Swallow tablets whole — do not crush or split
Oral suspension
How this form is used
- Augmentin oral suspension treats lower respiratory tract infections, ear infections, sinusitis, skin and skin structure infections, and urinary tract infections in adults and pediatric patients
- Augmentin ES-600 oral suspension is specifically indicated for recurrent or persistent acute otitis media in children aged 3 months to 12 years weighing 40 kg or less, with specific risk factors such as recent antibiotic use or daycare attendance
- Amoxicillin and Clavulanate Potassium oral suspension is indicated for pediatric patients weighing less than 40 kg and for adults or children who cannot swallow tablets, for lower respiratory tract infections, sinusitis, ear infections, skin infections, and urinary tract infections
- Augmentin ES-600 and other 600 mg/42.9 mg per 5 mL suspensions should be taken at the start of a meal to reduce stomach upset and improve clavulanate absorption
- Augmentin oral suspension and Amoxicillin and Clavulanate Potassium oral suspension can be taken with or without food, but starting a meal before dosing is recommended
- Shake the suspension well before each use and follow your pharmacist's instructions for storage and any discard date after reconstitution
Show 6 more strengths Show fewer strengths
Chewable tablet
How this form is used
- Chewable tablets are indicated for lower respiratory tract infections, acute bacterial otitis media, sinusitis, skin and skin structure infections, and urinary tract infections in adults and pediatric patients
- Chewable tablets may be taken with or without food, but taking them at the start of a meal is recommended to improve clavulanate absorption and minimize stomach upset
- People with phenylketonuria (PKU) should know that chewable tablets contain phenylalanine — check with your doctor or pharmacist before use
Extended-release tablet
How this form is used
- Amoxicillin and Clavulanate Potassium Extended-Release Tablets treat community-acquired pneumonia in adults and pediatric patients weighing at least 40 kg who can swallow tablets
- Amoxicillin and Clavulanate Potassium Extended-Release Tablets treat acute bacterial sinusitis in adults and pediatric patients weighing at least 40 kg who can swallow tablets
- Amoxicillin and Clavulanate Potassium Extended-Release Tablets are for patients who weigh at least 40 kg and are able to swallow tablets
- Follow your prescriber's instructions for timing and duration of the full course
📊 Amoxicillin / Clavulanate across the U.S. market
How Amoxicillin / Clavulanate 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.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (1) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Amoxicillin / Clavulanate is used
A general measure of how commonly Amoxicillin / Clavulanate 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 Amoxicillin / Clavulanate 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.
How commonly is Amoxicillin / Clavulanate prescribed? Of the 1,596 medications we measure, Amoxicillin / Clavulanate ranks #37 by Medicaid prescriptions — more than 98% of them.
Utilization by Amoxicillin / Clavulanate 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.
amoxicillin 875 MG / clavulanate 125 MG Oral Tablet Most dispensed
Summed across the 14 of 318 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 562508
amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral Suspension
Summed across the 20 of 59 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 617993
amoxicillin 80 MG/ML / clavulanate 11.4 MG/ML Oral Suspension
Summed across the 13 of 46 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 617430
amoxicillin 500 MG / clavulanate 125 MG Oral Tablet
Summed across the 8 of 140 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 617296
amoxicillin 50 MG/ML / clavulanate 12.5 MG/ML Oral Suspension
Summed across the 12 of 22 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 617322
amoxicillin 40 MG/ML / clavulanate 5.7 MG/ML Oral Suspension
Summed across the 11 of 32 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 617423
12 HR amoxicillin 1000 MG / clavulanate 62.5 MG Extended Release Oral Tablet
Summed across the 2 of 7 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 617995
amoxicillin 250 MG / clavulanate 125 MG Oral Tablet
Summed across the 5 of 19 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 562251
Other Amoxicillin / Clavulanate products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)
Summed across the 1 of 34 listed NDC products with Medicaid activity.
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 Amoxicillin / Clavulanate, 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 86 of 677 listed Amoxicillin / Clavulanate NDCs with Medicaid activity.
🔍 Compare Amoxicillin / Clavulanate products
A representative set of FDA-listed product records for Amoxicillin / Clavulanate — 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.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Oral suspension | ||||
| AMOXICILLIN 200 mg/5 mL; CLAVULANATE POTASSIUM 28.5 mg/5 mL | Oral | A-S Medication Solutions × 2 listings | ANDA | View NDC → |
| AMOXICILLIN 400 mg/5 mL; CLAVULANATE POTASSIUM 57 mg/5 mL | Oral | A-S Medication Solutions × 6 listings | ANDA | View NDC → |
| AMOXICILLIN 400 mg/5 mL; CLAVULANIC ACID 57 mg/5 mL | Oral | A-S Medication Solutions | ANDA | View NDC → |
| AMOXICILLIN 600 mg/5 mL; CLAVULANATE POTASSIUM 42.9 mg/5 mL | Oral | A-S Medication Solutions × 2 listings | ANDA | View NDC → |
| 200; 28.5 mg/5 mL; mg/5 mL | Oral | A-S Medication Solutions × 5 listings | ANDA | View NDC → |
| 400; 57 mg/5 mL; mg/5 mL | Oral | A-S Medication Solutions × 9 listings | ANDA | View NDC → |
| 600; 42.9 mg/5 mL; mg/5 mL | Oral | A-S Medication Solutions × 5 listings | ANDA | View NDC → |
| AMOXICILLIN 125 mg/5 mL; CLAVULANATE POTASSIUM 31.25 mg/5 mL | Oral | Allegis Holdings, LLC | NDA | View NDC → |
| 125; 31.25 mg/5 mL; mg/5 mL | Oral | Allegis Holdings, LLC | NDA | View NDC → |
| 125; 31.25 mg/5 mL; mg/5 mL | Oral | Allegis Pharmaceuticals, LLC | NDA | View NDC → |
| AMOXICILLIN 200 mg/5 mL; CLAVULANATE POTASSIUM 28.5 mg/5 mL | Oral | Asclemed USA, Inc. | ANDA | View NDC → |
| AMOXICILLIN 400 mg/5 mL; CLAVULANATE POTASSIUM 57 mg/5 mL | Oral | Asclemed USA, Inc. | ANDA | View NDC → |
| AMOXICILLIN 125 mg/5 mL; CLAVULANATE POTASSIUM 31.25 mg/5 mL | Oral | Aurobindo Pharma Limited × 2 listings | ANDA | View NDC → |
| AMOXICILLIN 200 mg/5 mL; CLAVULANATE POTASSIUM 28.5 mg/5 mL | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| AMOXICILLIN 250 mg/5 mL; CLAVULANATE POTASSIUM 62.5 mg/5 mL | Oral | Aurobindo Pharma Limited × 2 listings | ANDA | View NDC → |
| AMOXICILLIN 400 mg/5 mL; CLAVULANATE POTASSIUM 57 mg/5 mL | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| AMOXICILLIN 600 mg/5 mL; CLAVULANATE POTASSIUM 42.9 mg/5 mL | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 125; 31.25 mg/5 mL; mg/5 mL | Oral | Aurobindo Pharma Limited × 2 listings | ANDA | View NDC → |
| 200; 28.5 mg/5 mL; mg/5 mL | Oral | Aurobindo Pharma Limited × 2 listings | ANDA | View NDC → |
| 250; 62.5 mg/5 mL; mg/5 mL | Oral | Aurobindo Pharma Limited × 2 listings | ANDA | View NDC → |
| 400; 57 mg/5 mL; mg/5 mL | Oral | Aurobindo Pharma Limited × 2 listings | ANDA | View NDC → |
| 600; 42.9 mg/5 mL; mg/5 mL | Oral | Aurobindo Pharma Limited × 2 listings | ANDA | View NDC → |
| 200; 28.5 mg/5 mL; mg/5 mL | Oral | Bionpharma Inc. | ANDA | View NDC → |
| 400; 57 mg/5 mL; mg/5 mL | Oral | Bionpharma Inc. | ANDA | View NDC → |
| AMOXICILLIN 200 mg/5 mL; CLAVULANATE POTASSIUM 28.5 mg/5 mL | Oral | Chartwell RX, LLC × 3 listings | ANDA | View NDC → |
| AMOXICILLIN 400 mg/5 mL; CLAVULANATE POTASSIUM 57 mg/5 mL | Oral | Chartwell RX, LLC × 3 listings | ANDA | View NDC → |
| AMOXICILLIN 600 mg/5 mL; CLAVULANATE POTASSIUM 42.9 mg/5 mL | Oral | Chartwell RX, LLC | ANDA | View NDC → |
| AMOXICILLIN 250 mg/5 mL; CLAVULANATE POTASSIUM 62.5 mg/5 mL | Oral | Cipla USA Inc. | ANDA | View NDC → |
| 250; 62.5 mg/5 mL; mg/5 mL | Oral | Cronus Pharma LLC | ANDA | Find on DailyMed ↗ |
| AMOXICILLIN 250 mg/5 mL; CLAVULANATE POTASSIUM 62.5 mg/5 mL | Oral | Devatis, Inc. | ANDA | View NDC → |
| AMOXICILLIN 400 mg/5 mL; CLAVULANATE POTASSIUM 57 mg/5 mL | Oral | Devatis, Inc. | ANDA | View NDC → |
| AMOXICILLIN 600 mg/5 mL; CLAVULANATE POTASSIUM 42.9 mg/5 mL | Oral | Devatis Inc. | ANDA | View NDC → |
| AMOXICILLIN 200 mg/5 mL; CLAVULANATE POTASSIUM 28.5 mg/5 mL | Oral | Hawaii Repack, Inc. | ANDA | View NDC → |
| AMOXICILLIN 400 mg/5 mL; CLAVULANATE POTASSIUM 57 mg/5 mL | Oral | Hawaii Repack, Inc. | ANDA | View NDC → |
| AMOXICILLIN 200 mg/5 mL; CLAVULANIC ACID 28.5 mg/5 mL | Oral | Hikma Pharmaceuticals USA Inc. | ANDA | View NDC → |
| AMOXICILLIN 400 mg/5 mL; CLAVULANIC ACID 57 mg/5 mL | Oral | Hikma Pharmaceuticals USA Inc. | ANDA | View NDC → |
| AMOXICILLIN 600 mg/5 mL; CLAVULANATE POTASSIUM 42.9 mg/5 mL | Oral | Hikma Pharmaceuticals USA Inc. | ANDA | View NDC → |
| 200; 28.5 mg/5 mL; mg/5 mL | Oral | Hikma Pharmaceuticals USA Inc. × 2 listings | ANDA | View NDC → |
| 400; 57 mg/5 mL; mg/5 mL | Oral | Hikma Pharmaceuticals USA Inc. × 2 listings | ANDA | View NDC → |
| 600; 42.9 mg/5 mL; mg/5 mL | Oral | Hikma Pharmaceuticals USA Inc. × 2 listings | ANDA | View NDC → |
| 400; 57 mg/5 mL; mg/5 mL | Oral | medsource pharmaceuticals | ANDA | View NDC → |
| AMOXICILLIN 200 mg/5 mL; CLAVULANATE POTASSIUM 28.5 mg/5 mL | Oral | Micro Labs Limited | ANDA | View NDC → |
| AMOXICILLIN 400 mg/5 mL; CLAVULANATE POTASSIUM 57 mg/5 mL | Oral | Micro Labs Limited | ANDA | View NDC → |
| AMOXICILLIN 600 mg/5 mL; CLAVULANATE POTASSIUM 42.9 mg/5 mL | Oral | Micro Labs Limited | ANDA | View NDC → |
| 200; 28.5 mg/5 mL; mg/5 mL | Oral | Micro Labs Limited | ANDA | View NDC → |
| 400; 57 mg/5 mL; mg/5 mL | Oral | Micro Labs Limited | ANDA | View NDC → |
| 250; 62.5 mg/5 mL; mg/5 mL | Oral | Morton Grove Pharmaceuticals, Inc. × 2 listings | ANDA | View NDC → |
| AMOXICILLIN 200 mg/5 mL; CLAVULANATE POTASSIUM 28.5 mg/5 mL | Oral | NorthStar Rx LLC | ANDA | View NDC → |
| AMOXICILLIN 400 mg/5 mL; CLAVULANATE POTASSIUM 57 mg/5 mL | Oral | NorthStar Rx LLC | ANDA | View NDC → |
| AMOXICILLIN 600 mg/5 mL; CLAVULANATE POTASSIUM 42.9 mg/5 mL | Oral | NorthStar Rx LLC | ANDA | View NDC → |
| 200; 28.5 mg/5 mL; mg/5 mL | Oral | NorthStar Rx LLC × 2 listings | ANDA | View NDC → |
| 400; 57 mg/5 mL; mg/5 mL | Oral | NorthStar Rx LLC × 2 listings | ANDA | View NDC → |
| 600; 42.9 mg/5 mL; mg/5 mL | Oral | NorthStar Rx LLC × 2 listings | ANDA | View NDC → |
| AMOXICILLIN 200 mg/5 mL; CLAVULANATE POTASSIUM 28.5 mg/5 mL | Oral | NuCare Pharmaceuticals, Inc. | ANDA | View NDC → |
| AMOXICILLIN 400 mg/5 mL; CLAVULANATE POTASSIUM 57 mg/5 mL | Oral | NuCare Pharmaceuticals,Inc. × 2 listings | ANDA | View NDC → |
| AMOXICILLIN 400 mg/5 mL; CLAVULANIC ACID 57 mg/5 mL | Oral | NuCare Pharmaceuticals,Inc. | ANDA | View NDC → |
| AMOXICILLIN 600 mg/5 mL; CLAVULANATE POTASSIUM 42.9 mg/5 mL | Oral | NuCare Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | View NDC → |
| AMOXICILLIN 600 mg/5 mL; CLAVULANATE POTASSIUM 42.9 mg/5 mL | Oral | NuCare Pharmaceuticals,Inc. × 4 listings | ANDA | View NDC → |
| 200; 28.5 mg/5 mL; mg/5 mL | Oral | NuCare Pharmaceuticals,Inc. × 2 listings | ANDA | View NDC → |
| 400; 57 mg/5 mL; mg/5 mL | Oral | NuCare Pharmaceuticals,Inc. × 8 listings | ANDA | View NDC → |
| 600; 42.9 mg/5 mL; mg/5 mL | Oral | NuCare Pharmaceuticals,Inc. × 8 listings | ANDA | View NDC → |
| AMOXICILLIN 600 mg/5 mL; CLAVULANATE POTASSIUM 42.9 mg/5 mL | Oral | Preferred Pharmaceuticals, Inc. | ANDA | View NDC → |
| 200; 28.5 mg/5 mL; mg/5 mL | Oral | Preferred Pharmaceuticals, Inc. × 2 listings | ANDA | View NDC → |
| 400; 57 mg/5 mL; mg/5 mL | Oral | Preferred Pharmaceuticals, Inc. × 2 listings | ANDA | View NDC → |
| 600; 42.9 mg/5 mL; mg/5 mL | Oral | Preferred Pharmaceuticals, Inc. × 2 listings | ANDA | View NDC → |
| AMOXICILLIN 200 mg/5 mL; CLAVULANATE POTASSIUM 28.5 mg/5 mL | Oral | Preferred Pharmaceuticals Inc. | ANDA | View NDC → |
| AMOXICILLIN 400 mg/5 mL; CLAVULANATE POTASSIUM 57 mg/5 mL | Oral | Preferred Pharmaceuticals Inc. | ANDA | View NDC → |
| AMOXICILLIN 400 mg/5 mL; CLAVULANIC ACID 57 mg/5 mL | Oral | Preferred Pharmaceuticals Inc. | ANDA | View NDC → |
| AMOXICILLIN 600 mg/5 mL; CLAVULANATE POTASSIUM 42.9 mg/5 mL | Oral | Preferred Pharmaceuticals Inc. × 3 listings | ANDA | View NDC → |
| 200; 28.5 mg/5 mL; mg/5 mL | Oral | Preferred Pharmaceuticals Inc. × 4 listings | ANDA | View NDC → |
| 400; 57 mg/5 mL; mg/5 mL | Oral | Preferred Pharmaceuticals Inc. × 3 listings | ANDA | View NDC → |
| 600; 42.9 mg/5 mL; mg/5 mL | Oral | Preferred Pharmaceuticals Inc. × 5 listings | ANDA | View NDC → |
| AMOXICILLIN 400 mg/5 mL; CLAVULANATE POTASSIUM 57 mg/5 mL | Oral | Proficient Rx LP × 2 listings | ANDA | View NDC → |
| AMOXICILLIN 400 mg/5 mL; CLAVULANATE POTASSIUM 57 mg/5 mL | Oral | Proficient Rx LP | NDA | View NDC → |
| AMOXICILLIN 400 mg/5 mL; CLAVULANIC ACID 57 mg/5 mL | Oral | Proficient Rx LP | ANDA | View NDC → |
| AMOXICILLIN 600 mg/5 mL; CLAVULANATE POTASSIUM 42.9 mg/5 mL | Oral | Proficient Rx LP × 4 listings | ANDA | View NDC → |
| 200; 28.5 mg/5 mL; mg/5 mL | Oral | Proficient Rx LP | ANDA | View NDC → |
| 400; 57 mg/5 mL; mg/5 mL | Oral | Proficient Rx LP × 2 listings | ANDA | View NDC → |
| AMOXICILLIN 600 mg/5 mL; CLAVULANATE POTASSIUM 42.9 mg/5 mL | Oral | Redpharm Drug | NDA AUTHORIZED GENERIC | View NDC → |
| AMOXICILLIN 600 mg/5 mL; CLAVULANATE POTASSIUM 42.9 mg/5 mL | Oral | Redpharm Drug | ANDA | View NDC → |
| 200; 28.5 mg/5 mL; mg/5 mL | Oral | RPK Pharmaceuticals, Inc. × 3 listings | ANDA | View NDC → |
| 400; 57 mg/5 mL; mg/5 mL | Oral | RPK Pharmaceuticals, Inc. × 2 listings | ANDA | View NDC → |
| 600; 42.9 mg/5 mL; mg/5 mL | Oral | RPK Pharmaceuticals, Inc. × 4 listings | ANDA | View NDC → |
| AMOXICILLIN 200 mg/5 mL; CLAVULANATE POTASSIUM 28.5 mg/5 mL | Oral | Sandoz Inc | ANDA | View NDC → |
| AMOXICILLIN 400 mg/5 mL; CLAVULANATE POTASSIUM 57 mg/5 mL | Oral | Sandoz Inc | ANDA | View NDC → |
| 200; 28.5 mg/5 mL; mg/5 mL | Oral | Sandoz Inc × 4 listings | ANDA | View NDC → |
| 400; 57 mg/5 mL; mg/5 mL | Oral | Sandoz Inc × 4 listings | ANDA | View NDC → |
| AMOXICILLIN 200 mg/5 mL; CLAVULANATE POTASSIUM 28.5 mg/5 mL | Oral | Teva Pharmaceuticals USA, Inc. | ANDA | View NDC → |
| AMOXICILLIN 400 mg/5 mL; CLAVULANATE POTASSIUM 57 mg/5 mL | Oral | Teva Pharmaceuticals USA, Inc. | ANDA | View NDC → |
| AMOXICILLIN 600 mg/5 mL; CLAVULANATE POTASSIUM 42.9 mg/5 mL | Oral | Teva Pharmaceuticals USA, Inc. | ANDA | View NDC → |
| 200; 28.5 mg/5 mL; mg/5 mL | Oral | Teva Pharmaceuticals USA, Inc. × 2 listings | ANDA | View NDC → |
| 400; 57 mg/5 mL; mg/5 mL | Oral | Teva Pharmaceuticals USA, Inc. × 2 listings | ANDA | View NDC → |
| 600; 42.9 mg/5 mL; mg/5 mL | Oral | Teva Pharmaceuticals USA, Inc. × 2 listings | ANDA | View NDC → |
| AMOXICILLIN 125 mg/5 mL; CLAVULANATE POTASSIUM 31.25 mg/5 mL | Oral | USAntibiotics, LLC × 2 listings | NDA AUTHORIZED GENERIC | View NDC → |
| AMOXICILLIN 250 mg/5 mL; CLAVULANATE POTASSIUM 62.5 mg/5 mL | Oral | USAntibiotics, LLC × 2 listings | NDA AUTHORIZED GENERIC | View NDC → |
| AMOXICILLIN 600 mg/5 mL; CLAVULANATE POTASSIUM 42.9 mg/5 mL | Oral | USAntibiotics, LLC × 2 listings | NDA | View NDC → |
| AMOXICILLIN 600 mg/5 mL; CLAVULANATE POTASSIUM 42.9 mg/5 mL | Oral | USAntibiotics, LLC × 2 listings | NDA AUTHORIZED GENERIC | View NDC → |
| 125; 31.25 mg/5 mL; mg/5 mL | Oral | USAntibiotics, LLC | NDA AUTHORIZED GENERIC | View NDC → |
| 250; 62.5 mg/5 mL; mg/5 mL | Oral | USAntibiotics, LLC | NDA AUTHORIZED GENERIC | View NDC → |
| 600; 42.9 mg/5 mL; mg/5 mL | Oral | USAntibiotics, LLC | NDA | View NDC → |
| 600; 42.9 mg/5 mL; mg/5 mL | Oral | USAntibiotics, LLC | NDA AUTHORIZED GENERIC | View NDC → |
| 💊Bulk drug substance | ||||
| AMOXICILLIN 0.8 kg/kg; CLAVULANATE POTASSIUM 0.2 kg/kg | — | Shandong New Time Pharmaceutical Co., Ltd. | DRUG FOR FURTHER PROCESSING | View NDC → |
Showing 200 of 572 products — FDA National Drug Code Directory. See every product, package size and price: browse all 572 Amoxicillin / Clavulanate NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Amoxicillin / Clavulanate — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Amoxicillin / Clavulanate in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Amoxicillin / Clavulanate went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one exact multiple-ingredient concept (MIN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). A product with a different ingredient combination belongs on a different page.
RxCUI 19711 4 dose forms · 22 strengths
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Dose form (SCDF) Chewable Tablet RxCUI 562252In current FDA listingsClinical drug / strength (SCD) amoxicillin 100 MG / clavulanate 25 MGRxCUI 2105786amoxicillin 125 MG / clavulanate 31.2 MGRxCUI 562253amoxicillin 200 MG / clavulanate 28.5 MGRxCUI 617309amoxicillin 200 MG / clavulanate 50 MGRxCUI 2105792amoxicillin 250 MG / clavulanate 62.5 MGRxCUI 617304amoxicillin 300 MG / clavulanate 75 MGRxCUI 2105795amoxicillin 400 MG / clavulanate 57 MGRxCUI 617316amoxicillin 50 MG / clavulanate 12.5 MGRxCUI 2105798 -
Dose form (SCDF) Extended Release Oral Tablet RxCUI 617988In current FDA listingsClinical drug / strength (SCD) 12 HR amoxicillin 1000 MG / clavulanate 62.5 MGRxCUI 617995 -
Dose form (SCDF) Oral Suspension RxCUI 617301In current FDA listingsClinical drug / strength (SCD) amoxicillin 120 MG/ML / clavulanate 8.58 MG/MLRxCUI 617993amoxicillin 25 MG/ML / clavulanate 6.25 MG/MLRxCUI 617302amoxicillin 40 MG/ML / clavulanate 5.7 MG/MLRxCUI 617423amoxicillin 50 MG/ML / clavulanate 12.5 MG/MLRxCUI 617322amoxicillin 80 MG/ML / clavulanate 11.4 MG/MLRxCUI 617430 -
Dose form (SCDF) Oral Tablet RxCUI 562250In current FDA listingsClinical drug / strength (SCD) amoxicillin 100 MG / clavulanate 25 MGRxCUI 2105776amoxicillin 200 MG / clavulanate 50 MGRxCUI 1810270amoxicillin 250 MG / clavulanate 125 MGRxCUI 562251amoxicillin 300 MG / clavulanate 75 MGRxCUI 1810273amoxicillin 50 MG / clavulanate 12.5 MGRxCUI 1810268amoxicillin 500 MG / clavulanate 125 MGRxCUI 617296amoxicillin 800 MG / clavulanate 125 MGRxCUI 617996amoxicillin 875 MG / clavulanate 125 MGRxCUI 562508
Look up RxCUI 19711 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Amoxicillin / Clavulanate is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
…and 16 more on the FDA NDC directory.
RxNorm drug class
Amoxicillin / Clavulanate belongs to the beta Lactamase Inhibitor class.
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.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 201 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.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. 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. USAntibiotics, LLC 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.