Amoxicillin
Amoxicillin is a penicillin-type antibiotic used to treat certain bacterial infections of the ear, nose, throat, lungs, urinary tract and skin, and (in adults) H. pylori infection with duodenal ulcer disease.
🧬 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 246 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 is a penicillin-type antibiotic that kills bacteria by blocking how they build their cell walls. It is used for certain ear, nose, throat, lung, urinary and skin infections and, alongside other medicines, for H. pylori ulcers in adults; on the market since about 1974 and available as a generic, it is a familiar first choice. Most people tolerate it well, and loose stools, nausea or a mild rash are what they usually notice. Watch for a serious allergic reaction (trouble breathing, swelling, severe hives), which is more likely after a past penicillin reaction, so stop it and get emergency help. Also call your prescriber if a rash spreads or diarrhea turns watery or bloody, even months later.
Clinical pearls
- Take it at the start of a meal to ease stomach upset, and finish the course even after you feel better.
- If mononucleosis is a possibility, say so first, since amoxicillin very often causes a rash in people with mono.
- If you take an oral blood thinner such as warfarin, your INR (a clotting test) may need checking, since amoxicillin can strengthen its effect.
- Amoxicillin may make combined estrogen-progesterone birth control less effective, so consider backup contraception while taking it.
Patient information guide A plain-language walkthrough of Amoxicillin, written from its FDA label.
What Amoxicillin is used for
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Amoxicillin treats infections caused by susceptible, beta-lactamase-negative bacteria. The supported uses are:
- Infections of the ear, nose and throat
- Infections of the genitourinary tract
- Infections of the skin and skin structure
- Infections of the lower respiratory tract
- Adults only: H. pylori infection and duodenal ulcer disease, as triple therapy with clarithromycin and lansoprazole
- Adults only: H. pylori dual therapy with lansoprazole, for people who are allergic or intolerant to clarithromycin or whose bacteria are resistant to it (Amoxil tablets and several amoxicillin labels)
- Acute uncomplicated gonorrhea (Amoxil and amoxicillin for oral suspension labels only), and only when the bacteria are known to be susceptible
How Amoxicillin works
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Amoxicillin is a penicillin-type antibacterial. It kills susceptible bacteria while they are multiplying by stopping them from building their cell walls.
Resistance happens mainly when bacteria make beta-lactamase enzymes that break amoxicillin apart. That is why it is only indicated for susceptible, beta-lactamase-negative bacteria.
Amoxicillin dosage
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Amoxicillin is taken by mouth, usually every 8 to 12 hours. Your dose depends on the infection, its severity, and (for children) body weight.
- Take it at the start of a meal to reduce stomach upset.
- Keep taking it for at least 48 to 72 hours after symptoms resolve, and at least 10 days for Streptococcus pyogenes infections.
- People with severe kidney problems may need a lower dose.
- H. pylori treatment is given with other medicines, usually for 14 days.
Follow your prescriber’s directions and the label.
Dosing details from the FDA-approved label
From the Amoxicillin prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Ear/Nose/Throat, Skin/Skin Structure, Genitourinary Tract infections - Mild/Moderate (adults)
- 500 mg every 12 hours or 250 mg every 8 hours
- Continue at least 48 to 72 hours beyond asymptomatic; at least 10 days for Streptococcus pyogenes
- Ear/Nose/Throat, Skin/Skin Structure, Genitourinary Tract infections - Mild/Moderate (children > 3 months)
- 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours
- Children's dosage for weight less than 40 kg; 40 kg or more dosed per adult recommendations
- Ear/Nose/Throat, Skin/Skin Structure, Genitourinary Tract infections - Severe (adults)
- 875 mg every 12 hours or 500 mg every 8 hours
- Also used for infections with bacteria intermediate in susceptibility
- Ear/Nose/Throat, Skin/Skin Structure, Genitourinary Tract infections - Severe (children > 3 months)
- 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours
- Children's dosage for weight less than 40 kg
- Lower Respiratory Tract infections - Mild/Moderate or Severe (adults)
- 875 mg every 12 hours or 500 mg every 8 hours
- Lower Respiratory Tract infections - Mild/Moderate or Severe (children > 3 months)
- 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours
- Children's dosage for weight less than 40 kg
- Gonorrhea, acute uncomplicated ano-genital and urethral infections (adults)
- 3 grams as single oral dose
- Gonorrhea (prepubertal children)
- 50 mg/kg amoxicillin combined with 25 mg/kg probenecid as a single dose
- Do not use this regimen in children under 2 years of age
- Neonates and infants aged ≤ 12 weeks (≤ 3 months)
- Recommended upper dose 30 mg/kg/day divided every 12 hours
- Maximum: 30 mg/kg/day
- Incompletely developed renal function; no dosing recommendations for pediatric patients with impaired renal function
- H. pylori infection (adults)
- Triple therapy: 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all twice daily (every 12 hours) for 14 days
- Dual therapy: 1 gram amoxicillin and 30 mg lansoprazole, each three times daily (every 8 hours) for 14 days
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION • In adults, 750-1750 mg/day in divided doses every 8-12 hours. In Pediatric Patients > 3 Months of Age, 20-45 mg/kg/day in divided doses every 8-12 hours. Refer to full prescribing information for specific dosing regimens. ( 2.1 , 2.2 , 2.3 ) • Treatment of gonorrhea is 3 grams as a single oral dose. ( 2.1 ) • The upper dose for neonates and infants ≤ 3 months is 30 mg/kg/day divided every 12 hours. ( 2.2 ) • Dosing for H. pylori Infection: Triple therapy: 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days. Dual therapy: 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days. ( 2.3 ) • Reduce the dose in patients with severe renal impairment (GFR <30mL/min). ( 2.4 ) 2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age Infection Severity a Usual Adult Dose Usual Dose for Children > 3 Months b Ear/Nose/Throat Skin/ Skin Structure Genitourinary Tract Mild/ Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours Lower Respiratory Tract Mild/ Moderate or Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours Gonorrhea Acute, uncomplicated ano-genital and urethral infections in males and females 3 grams as single oral dose Prepubertal children: 50 mg/kg amoxicillin, combined with 25 mg/kg probenecid as a single dose. Note: since probenecid is contraindicated in children under 2 years.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Amoxicillin side effects
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The most common side effects in clinical trials were:
Common side effects
- Diarrhea
- Rash
- Nausea
- Vomiting
- Headache (when used in H. pylori combination therapy)
- Taste changes (when used in H. pylori triple therapy)
When to get medical help
- Seek emergency help for signs of a serious allergic reaction (anaphylaxis), such as trouble breathing, swelling or severe hives.
- Stop the medicine and call your doctor if a skin rash spreads or worsens, since severe skin reactions can occur.
- Call your doctor if you have severe vomiting 1 to 4 hours after a dose, especially in a child, as it may be drug-induced enterocolitis syndrome (DIES).
- Call your doctor if you have watery or bloody diarrhea, which can start even more than 2 months after treatment.
- Report yellowing of the skin or eyes, unusual bruising or bleeding, confusion or seizures.
Amoxicillin warnings and precautions
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- Serious allergic reactions: Anaphylaxis can be fatal and is more likely in people with a penicillin allergy history. Stop the drug if it occurs.
- Severe skin reactions: Includes SJS, TEN, DRESS and AGEP. Stop if a rash progresses.
- DIES: Protracted vomiting 1 to 4 hours after a dose, mostly in children under 18.
- C. difficile diarrhea: Can range from mild to fatal and can appear over 2 months after treatment.
- Mononucleosis: A high percentage develop a rash, so amoxicillin should not be given.
- Resistance: Use without a bacterial infection offers no benefit and promotes resistant bacteria.
Amoxicillin interactions
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These are the key interactions:
- Probenecid: slows amoxicillin clearance, raising blood levels.
- Oral anticoagulants: INR may rise, so monitoring is needed.
- Allopurinol: increases the rate of rash.
- Combined oral contraceptives: may be less effective.
- Chloramphenicol, macrolides, sulfonamides, tetracyclines: may interfere with amoxicillin’s killing effect.
- Urine glucose tests: some tests may give false positives.
Interactions listed in the FDA-approved label
From the Amoxicillin prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Probenecid: Probenecid decreases renal tubular secretion of amoxicillin, which may result in increased and prolonged blood levels of amoxicillin.
- Oral anticoagulants: Abnormal prolongation of prothrombin time (increased INR) has been reported in patients receiving amoxicillin and oral anticoagulants. Appropriate monitoring should be undertaken; adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation.
- Allopurinol: Concurrent use increases the incidence of rashes compared to amoxicillin alone.
- Oral contraceptives: Amoxicillin may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.
- Other antibacterials (chloramphenicol, macrolides, sulfonamides, tetracyclines): May interfere with the bactericidal effects of penicillin, demonstrated in vitro; clinical significance is not well documented.
- Urine glucose tests (CLINITEST, Benedict's Solution, Fehling's Solution): High urine concentrations of ampicillin may cause false-positive urine glucose results, and this may also occur with amoxicillin. Use glucose tests based on enzymatic glucose oxidase reactions (such as CLINISTIX).
Read the label’s full interactions text
7 DRUG INTERACTIONS • Probenicid decreases renal tubular secretion of amoxicillin which may result in increased blood levels of amoxicillin. ( 7.1 ) • Concomitant use of amoxicillin and oral anticoagulants may increase the prolongation of prothrombin time. ( 7.2 ) • Coadministration with allopurinol increases the risk of rash. ( 7.3 ) • Amoxicillin may reduce the efficacy of oral contraceptives. ( 7.4 ) 7.1 Probenecid Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use of amoxicillin and probenecid may result in increased and prolonged blood levels of amoxicillin. 7.2 Oral Anticoagulants Abnormal prolongation of prothrombin time (increased international normalized ratio [INR]) has been reported in patients receiving amoxicillin and oral anticoagulants. Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation. 7.3 Allopurinol The concurrent administration of allopurinol and amoxicillin increases the incidence of rashes in patients receiving both drugs as compared to patients receiving amoxicillin alone. It is not known whether this potentiation of amoxicillin rashes is due to allopurinol or the hyperuricemia present in these patients. 7.4 Oral Contraceptives Amoxicillin may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives. 7.5 Other Antibacterials Chloramphenicol, macrolides, sulfonamides, and tetracyclines may interfere with the bactericidal effects of penicillin. This has been demonstrated in vitro ; however, the clinical significance of this interaction is notwell documented.
Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Amoxicillin
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- Do not use it after a serious allergic reaction to amoxicillin, penicillins or cephalosporins.
- Tell your prescriber about past reactions to penicillins, cephalosporins or other allergens.
- Pregnancy: use only if clearly needed.
- Breastfeeding: amoxicillin passes into milk and may sensitize the infant.
- Children: infants 3 months or younger need modified dosing. H. pylori use has not been established in children.
- Older adults: kidney function may be lower, so dose selection and monitoring matter.
- Kidney impairment: dose adjustment is usually needed in severe impairment.
- Phenylketonuria: chewable tablets contain phenylalanine.
Amoxicillin overdose
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Large overdoses can cause kidney problems, including crystals in the urine (crystalluria) and, rarely, kidney inflammation or kidney failure. The label says to stop amoxicillin, treat symptoms, and keep up good fluid intake. Kidney problems appear reversible once the drug is stopped, and hemodialysis can remove amoxicillin.
What Amoxicillin does in the body
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Amoxicillin has bactericidal (bacteria-killing) action against susceptible bacteria that are actively multiplying. It works by inhibiting cell wall synthesis. It is active against most isolates of several bacteria, including Streptococcus, Staphylococcus, E. coli, H. influenzae, Proteus mirabilis, E. faecalis, N. gonorrhoeae and H. pylori.
How your body processes Amoxicillin
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Amoxicillin is stable in stomach acid and is absorbed rapidly after you swallow it. Blood levels peak about 1 to 2 hours after a dose. It spreads into most body tissues and fluids, but not into brain or spinal fluid unless the meninges are inflamed.
Its half-life is about 61 minutes. About 60% of a dose leaves in urine within 6 to 8 hours, mostly unchanged. Probenecid can delay this.
How to store Amoxicillin
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Store at or below 25° C (77° F) . Dispense in a tight container.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Amoxicillin
96 supplements and herbal products have documented interactions with Amoxicillin in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 6
- Moderate · 76
- Minor · 14
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Nutrient depletion considerations
Amoxicillin has been associated with lower levels of 8 nutrients in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.
- Higher significance · 6
- Moderate · 2
Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.
Amoxicillin: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Amoxicillin — the kind of thing our pharmacy team would talk through with you at the counter.
What is amoxicillin treating?
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How should I take it?
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What side effects are normal, and when should I call?
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I’m allergic to penicillin. Can I take this?
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Does it interact with my other medicines?
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Is it safe in pregnancy or while breastfeeding?
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Is Amoxicillin available over the counter?
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When was Amoxicillin first available?
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Who makes Amoxicillin?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Amoxicillin on HelloPharmacist
Amoxicillin forms and strengths (how it comes)
Amoxicillin 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.
Capsule
How this form is used
- Amoxicillin capsules are indicated for ear, nose and throat, genitourinary tract, skin and lower respiratory tract infections caused by susceptible bacteria.
- Amoxicillin is taken at the start of a meal to reduce stomach upset.
Oral suspension
How this form is used
- Amoxil for oral suspension is indicated for ear, nose and throat, genitourinary, skin and lower respiratory tract infections, acute uncomplicated gonorrhea, and H. pylori triple therapy.
- Amoxicillin for oral suspension is not recommended for first-choice treatment of gonorrhea because of high resistance rates.
- Amoxicillin oral suspension is taken at the start of a meal to reduce stomach upset.
- Amoxicillin oral suspension formulations do not contain phenylalanine.
Tablet
How this form is used
- Amoxil tablets are indicated for ear, nose and throat, genitourinary tract, skin and lower respiratory tract infections caused by susceptible bacteria.
- Amoxil tablets are also used with other medicines for H. pylori infection with duodenal ulcer disease.
- Amoxicillin tablets are taken at the start of a meal to reduce stomach upset.
Chewable tablet
How this form is used
- Amoxicillin chewable tablets are indicated for ear, nose and throat, genitourinary tract, skin and lower respiratory tract infections caused by susceptible bacteria.
- Amoxicillin is taken at the start of a meal to reduce stomach upset.
- Amoxicillin chewable tablets contain aspartame (phenylalanine), which matters for people with phenylketonuria.
Amoxicillin on the U.S. market: products, makers and brands
How Amoxicillin 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.
31 companies list 271 Amoxicillin product records with the FDA, mostly as capsule, oral suspension, tablet; the earliest marketing or approval year on record is 1974. Brand names on the directory include Amoxil, Larotid Suspension, Moxtag and 10 more; the rest are generics.
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 (23) — 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 is used (Medicaid data)
A general measure of how commonly Amoxicillin 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 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 prescribed? Of the 1,601 medications we measure, Amoxicillin ranks #7 by Medicaid prescriptions — more than 100% of them.
Utilization by Amoxicillin 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 80 MG/ML Oral Suspension Most dispensed
Summed across the 18 of 56 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 308189
amoxicillin 500 MG Oral Capsule
Summed across the 20 of 428 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 308191
amoxicillin 875 MG Oral Tablet
Summed across the 8 of 109 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 308194
amoxicillin 500 MG Oral Tablet
Summed across the 3 of 23 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 308192
amoxicillin 50 MG/ML Oral Suspension
Summed across the 12 of 50 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 239191
amoxicillin 25 MG/ML Oral Suspension
Summed across the 9 of 30 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 313797
amoxicillin 40 MG/ML Oral Suspension
Summed across the 11 of 27 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 313850
amoxicillin 250 MG Oral Capsule
Summed across the 10 of 106 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 308182
amoxicillin 250 MG Chewable Tablet
Summed across the 1 of 34 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 598025
amoxicillin 125 MG Chewable Tablet
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 308177
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, 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 93 of 864 listed Amoxicillin NDCs with Medicaid activity.
Compare Amoxicillin products
A representative set of FDA-listed product records for Amoxicillin — 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 |
|---|---|---|---|---|
| 💊Capsule | ||||
| 250 mg | Oral | A-S Medication Solutions | ANDA | View NDC → |
| 500 mg | Oral | A-S Medication Solutions × 16 listings | ANDA | View NDC → |
| 500 mg | Oral | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | View NDC → |
| 250 mg | Oral | American Health Packaging | ANDA | View NDC → |
| 500 mg | Oral | American Health Packaging | ANDA | View NDC → |
| 250 mg | Oral | Asclemed USA, Inc. | ANDA | View NDC → |
| 500 mg | Oral | Asclemed USA, Inc. × 6 listings | ANDA | View NDC → |
| 250 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 500 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 250 mg | Oral | Bryant Ranch Prepack × 2 listings | ANDA | View NDC → |
| 500 mg | Oral | Bryant Ranch Prepack × 9 listings | ANDA | View NDC → |
| 250 mg | Oral | Chartwell Governmental & Specialty RX, LLC | ANDA | View NDC → |
| 500 mg | Oral | Chartwell Governmental & Specialty RX, LLC × 2 listings | ANDA | View NDC → |
| 250 mg | Oral | Chartwell RX, LLC | ANDA | View NDC → |
| 500 mg | Oral | Chartwell RX, LLC | ANDA | View NDC → |
| 250 mg | Oral | Coupler LLC | ANDA | View NDC → |
| 500 mg | Oral | Coupler LLC × 2 listings | ANDA | View NDC → |
| 500 mg | Oral | Hawaii Repack, Inc. | ANDA | View NDC → |
| 500 mg | Oral | Health Department, Oklahoma State | ANDA | View NDC → |
| 500 mg | Oral | Hikma Pharmaceuticals USA Inc. | ANDA | View NDC → |
| 250 mg | Oral | Micro Labs Limited | ANDA | View NDC → |
| 500 mg | Oral | Micro Labs Limited | ANDA | View NDC → |
| 250 mg | Oral | NorthStar Rx LLC | ANDA | View NDC → |
| 500 mg | Oral | NorthStar Rx LLC | ANDA | View NDC → |
| 250 mg | Oral | Northwind Health Company, LLC | ANDA | View NDC → |
| 500 mg | Oral | Northwind Health Company, LLC | ANDA | View NDC → |
| 500 mg | Oral | Northwind Pharmaceuticals, LLC | ANDA | View NDC → |
| 500 mg | Oral | NuCare Pharmaceutials,Inc. | ANDA | View NDC → |
| 250 mg | Oral | NuCare Pharmaceuticals, Inc. | ANDA | View NDC → |
| 250 mg | Oral | NuCare Pharmaceuticals,Inc. × 5 listings | ANDA | View NDC → |
| 500 mg | Oral | NuCare Pharmaceuticals, Inc. | ANDA | View NDC → |
| 500 mg | Oral | NuCare Pharmaceuticals,Inc. × 10 listings | ANDA | View NDC → |
| 250 mg | Oral | PD-Rx Pharmaceuticals, Inc. | ANDA | View NDC → |
| 500 mg | Oral | PD-Rx Pharmaceuticals, Inc. × 4 listings | ANDA | View NDC → |
| 500 mg | Oral | Preferred Phamraceuticals Inc. | ANDA | View NDC → |
| 250 mg | Oral | Preferred Pharmaceuticals Inc. | ANDA | View NDC → |
| 250 mg | Oral | Proficient Rx LP | ANDA | View NDC → |
| 500 mg | Oral | Proficient Rx LP × 3 listings | ANDA | View NDC → |
| 500 mg | Oral | QPharma, Inc | ANDA | View NDC → |
| 500 mg | Oral | QPharma Inc × 2 listings | ANDA | View NDC → |
| 250 mg | Oral | Redpharm Drug × 3 listings | ANDA | View NDC → |
| 500 mg | Oral | Redpharm Drug × 2 listings | ANDA | View NDC → |
| 250 mg | Oral | Remedyrepack Inc. | ANDA | View NDC → |
| 500 mg | Oral | Remedyrepack Inc. × 4 listings | ANDA | View NDC → |
Showing 100 of 271 products — FDA National Drug Code Directory. See every product, package size and price: browse all 271 Amoxicillin NDCs →
Amoxicillin side effects reported to the 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 — a signal of what to watch for, not proof the drug caused it.
The effects most often named in FDA reports that mention Amoxicillin are diarrhoea, drug hypersensitivity, nausea; about 79% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.
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 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.
Amoxicillin FDA approval history
How Amoxicillin went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Amoxicillin was first approved by the FDA in 1974 (Brand: AMOXIL · Glaxosmithkline). It remains available in U.S. pharmacies today.
Source: Drugs@FDA.
Amoxicillin 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.
The FDA’s enforcement reports list 2 Amoxicillin recalls since July 2021, covering 3 product listings. None of them is still listed as ongoing. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.
- Amoxicillin Capsules, USP, 500 mg, 100-count bottle, Rx only, MFG: Sandoz Pharma, NDC 0781-2613-01 Lots: McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that i… FDA record D-1025-2022 →
- AMOXICILLIN Tablets, USP, 875MG, 20 Tablets, Rx Only, Manufactured by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540. NDC: 0781-5060-20 Lots: Batch LJ9004 FDA record D-0166-2024 →
- AMOXICILLIN for Oral Suspension USP, 400MG/5ML, 100ML (when reconstituted), Manufactured In Canada By: TEVA CANA LIMITED, Toronto, Canada M1B 2K9; Manufactured For: TEVA PHARMACEUTICALS USA, INC., No… Lots: Batch 35447184A FDA record D-0165-2024 →
Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 723 5 dose forms · 19 strengths
-
Dose form (SCDF) Chewable Tablet RxCUI 370577In current FDA listings -
Dose form (SCDF) Extended Release Oral Tablet RxCUI 802549No current FDA listingClinical drug / strength (SCD) 775 MGRxCUI 802550 -
Dose form (SCDF) Oral Capsule RxCUI 370578In current FDA listings -
Dose form (SCDF) Oral Suspension RxCUI 370576In current FDA listings -
Dose form (SCDF) Oral Tablet RxCUI 370579In current FDA listings
Look up RxCUI 723 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.
Amoxicillin supply and shortage status
Whether Amoxicillin 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.
💵 What Amoxicillin costs pharmacies (NADAC benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Capsule · Oral | 500 mg | $0.079 per capsule | NDC details & price history |
| Capsule · Oral | 250 mg | $0.069 per capsule | NDC details & price history |
| Powder, For Suspension · Oral | 400 mg/5 mL | $0.034–$0.044 per mL | NDC details & price history |
| Powder, For Suspension · Oral | 250 mg/5 mL | $0.024–$0.030 per mL | NDC details & price history |
| Powder, For Suspension · Oral | 125 mg/5 mL | $0.018–$0.023 per mL | NDC details & price history |
| Powder, For Suspension · Oral | 200 mg/5 mL | $0.036–$0.039 per mL | NDC details & price history |
| Tablet, Film Coated · Oral | 875 mg | $0.154 per tablet | NDC details & price history |
| Tablet, Film Coated · Oral | 500 mg | $0.085 per tablet | NDC details & price history |
| Tablet, Chewable · Oral | 250 mg | $0.304 per tablet | NDC details & price history |
| Tablet, Chewable · Oral | 125 mg | $0.208 per tablet | NDC details & price history |
Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.
Amoxicillin brand names
Amoxicillin is sold under 13 brand names in the FDA directory — Amoxil, Larotid Suspension, Moxtag, Amoxil Pediatric Drops and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Amoxicillin: manufacturers and labelers
31 companies list Amoxicillin products with the FDA. By number of product records, the largest are A-S Medication Solutions, NuCare Pharmaceuticals,Inc., Proficient Rx LP. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
…and 7 more on the FDA NDC directory.
Amoxicillin drug class (RxNorm)
Amoxicillin belongs to the Penicillin-class Antibacterial 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.
Sources for this Amoxicillin page
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 this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. USAntibiotics, LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →