Prescription medicine
Amoxicillin Brand names: Amoxil
Amoxicillin (Amoxil) is a prescription medicine with an FDA approval on record since 1974. FDA's NDC Directory lists it from 38 generic labelers, and pharmacies paid $0.0788 per amoxicillin 500 mg capsule in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the amoxicillin FDA label on DailyMed (effective February 22, 2024, Sandoz Inc); the NDA 50459 record on Drugs@FDA; every amoxicillin label on DailyMed.
Highlights of the record
FDA label of February 22, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageAdults and Pediatric Patients
Upper Respiratory Tract Infections of the Ear, Nose, and Throat Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus species.
Forms and strengths
- 125 mg
- 250 mg
- 500 mg
- 875 mg
- 125 mg/5ml
- 200 mg/5ml
- 250 mg/5ml
- 400 mg/5ml
Capsule; powder for suspension; film-coated tablet; chewable tablet; coated tablet.
On the market
- Earliest approval on file
- January 18, 1974 Amoxil, Glaxosmithkline; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 50 first December 9, 1974; 22 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 39 of which 38 under generic applications, 0 under brand applications, repackagers included
- Last listed patent
- May 7, 2027 Moxatag tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.0788 per capsule Amoxicillin 500 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 12 since 2013 0 Class I among all firms' recalls; latest April 13, 2022; 1 more by firms not listed as its makers
- FAERS reports
- 75,926 through July 30, 2026
What is amoxicillin used for?
From the label: indications and usageAdults and Pediatric Patients
Upper Respiratory Tract Infections of the Ear, Nose, and Throat Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus species. (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp. , or Haemophilus influenzae.
Infections of the Genitourinary Tract Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Escherichia coli, Proteus mirabilis, or Enterococcus faecalis. […]
Conditions named in the indications of amoxicillin's FDA labels, with every medicine labeled for each:
From other amoxicillin labelsAcid reflux and ulcers: Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
FDA pharmacologic class: Penicillin-class Antibacterial.
Source: FDA drug label (Amoxicillin), Sandoz Inc, effective February 22, 2024 (SPL set 13bd4214-9b7f-425b-af5f-fc1ddc678230), via openFDA; the full label on DailyMed
Is there a generic for amoxicillin (Amoxil)?
The FDA approved the first generic amoxicillin on December 9, 1974. 50 generic applications are approved; 22 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists amoxicillin from 38 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Amoxil for oral suspension; a patent listed only for Moxatag tablets runs to May 7, 2027. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1974 earliest approval on file
- 1974 first generic approved
- 2027 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for amoxicillin (Amoxil)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0788 per Amoxicillin 500 mg capsule, down 12% from $0.0896 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Amoxicillin 400 mg/5 mL suspension (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Amoxicillin 125 mg tablet chewable | Generic | $0.208 per tablet | $6.23 | n/a |
| Amoxicillin 125 mg/5 mL suspension | Generic | $0.0211 per mL | n/a | -2% |
| Amoxicillin 200 mg/5 mL suspension | Generic | $0.039 per mL | n/a | +10% |
| Amoxicillin 250 mg capsule | Generic | $0.0687 per capsule | $2.06 | +6% |
| Amoxicillin 250 mg tablet chewable | Generic | $0.304 per tablet | $9.13 | +5% |
| Amoxicillin 250 mg/5 mL suspension | Generic | $0.0245 per mL | n/a | -1% |
| Amoxicillin 400 mg/5 mL suspension | Generic | $0.0396 per mL | n/a | -7% |
| Amoxicillin 500 mg capsule | Generic | $0.0788 per capsule | $2.36 | -12% |
| Amoxicillin 500 mg tablet | Generic | $0.085 per tablet | $2.55 | -18% |
| Amoxicillin 875 mg tablet | Generic | $0.154 per tablet | $4.61 | -5% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has amoxicillin been recalled?
The FDA's Enforcement Report lists 13 recalls naming amoxicillin since 2013: 0 Class I (the most serious), 9 Class II, 4 Class III; 0 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of amoxicillin and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| April 13, 2022 | Class II | Mckesson Medical-Surgical Inc. Corporate Office | cGMP deviations: Temperature abuse |
| January 26, 2022 | Class II | CARDINAL HEALTHCARE | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. |
| March 15, 2021 | Class II | Cardinal Health Inc. not a listed maker | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
| April 12, 2019 | Class II | Teva Pharmaceuticals USA | Subpotent Product: assay results for Amoxicillin were below the specification limits. |
| December 21, 2016 | Class II | Teva Pharmaceuticals USA | Subpotency: due to a low, out of specification test result for assay during stability testing. |
| November 4, 2016 | Class III | West-Ward Pharmaceuticals Corp. | Labeling: Label Error on Declared Strength: Some bottles miss a color coded panel where the strength of the product is typically displayed. |
| August 18, 2016 | Class III | West-Ward Pharmaceuticals Corp. | Labeling: Label Error on Declared Strength- bottles missing colored coded panel where strength of the product is displayed. |
| June 24, 2016 | Class II | Teva North America | Superpotent drug: Out of specification test result for assay during stability testing. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the amoxicillin label say about other medicines?
The amoxicillin label names 7 other medicines in its interaction, contraindication or warning sections. The labels of 14 other medicines name amoxicillin. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Allopurinol | drug interactions | Coadministration with allopurinol increases the risk of rash. |
| Ampicillin | drug interactions | High urine concentrations of ampicillin may result in false-positive reactions when testing for the presence of glucose in urine using CLINITEST ® , Benedict’s Solution, or Fehling’s Solution. |
| Chloramphenicol | drug interactions | Other Antibacterials Chloramphenicol, macrolides, sulfonamides, and tetracyclines may interfere with the bactericidal effects of penicillin. |
| Estradiol | drug interactions | Following administration of ampicillin or amoxicillin to pregnant women, a transient decrease in plasma concentration of total conjugated estriol, estriol-glucuronide, conjugated estrone, and estradiol has been noted. |
| Estriol | drug interactions | Following administration of ampicillin or amoxicillin to pregnant women, a transient decrease in plasma concentration of total conjugated estriol, estriol-glucuronide, conjugated estrone, and estradiol has been noted. |
| Probenecid | drug interactions | Probenecid decreases the renal tubular secretion of amoxicillin. |
| Progesterone | drug interactions | Amoxicillin may affect the intestinal flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives. |
Other labels that name amoxicillin
Source: FDA drug label (Amoxicillin), Sandoz Inc, effective February 22, 2024 (SPL set 13bd4214-9b7f-425b-af5f-fc1ddc678230), via openFDA; the full label on DailyMed
What do FAERS reports show for amoxicillin?
The FDA Adverse Event Reporting System holds 75,926 reports that list amoxicillin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 5,023 are coded as a death and 27,897 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as amoxicillin?
23 other medicines are given the same way (oral) and in the same FDA class as amoxicillin or labeled mainly for the same use (bacterial infections), the same class first. Bacterial infections lists all 51 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Ampicillin | Bacterial infections | 3 labelers | $0.441 per capsule 500 mg capsule | A presentation being discontinued |
| Azithromycin | Bacterial infections | 47 labelers | $0.266 per tablet 250 mg tablet | A presentation being discontinued |
| Cephalexin | Bacterial infections | 36 labelers | $0.120 per capsule 500 mg capsule | No current entry |
| Metronidazole | Bacterial infections | 40 labelers | $0.102 per tablet 250 mg tablet | In shortage |
| Clindamycin | Bacterial infections | 40 labelers | $0.103 per capsule 150 mg capsule | In shortage |
| Sulfamethoxazole and trimethoprim | Bacterial infections | 42 labelers | $0.0448 per tablet Sulfamethoxazole-tmp ds tablet | No current entry |
| Levofloxacin | Bacterial infections | 35 labelers | $0.259 per tablet 750 mg tablet | No current entry |
| Cefdinir | Bacterial infections | 26 labelers | $0.458 per capsule 300 mg capsule | No current entry |
Every medicine labeled for the same conditions as amoxicillin
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does amoxicillin compare with medicines for the same use?
20 side-by-side pages set amoxicillin beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to amoxicillin
- 23 medicines for the same use
- Other penicillins
- the pharmacologic class, with prices and generics
- Amoxicillin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other