Prescription medicine
Amoxicillin and clavulanate Brand names: Augmentin; first approved as Augmentin '250'
Amoxicillin and clavulanate (Augmentin) is a prescription medicine with an FDA approval on record since 1984. FDA's NDC Directory lists it from 31 generic labelers, and pharmacies paid $0.0693 per mL (Amox-clav 600-42.9 mg/5 mL sus) in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the amoxicillin and clavulanate FDA label on DailyMed (effective May 1, 2025, Sandoz Inc); the NDA 50564 record on Drugs@FDA; every amoxicillin and clavulanate label on DailyMed.
Highlights of the record
FDA label of May 1, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageAmoxicillin and clavulanate potassium is indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below:
Lower Respiratory Tract Infections - caused by beta‑lactamase‑producing isolates of Haemophilus influenzae and Moraxella catarrhalis.
Forms and strengths
- 62.5 mg / 562.5 mg / 437.5 mg
- 125 mg/5ml / 31.25 mg/5ml
- 125 mg / 875 mg
- 125 mg / 500 mg
- 200 mg/5ml / 28.5 mg/5ml
- 200 mg / 28.5 mg
- 250 mg / 125 mg
- 250 mg/5ml / 62.5 mg/5ml
- 400 mg/5ml / 57 mg/5ml
- 400 mg / 57 mg
- 500 mg / 125 mg
- 562.5 mg / 437.5 mg / 62.5 mg
Film-coated tablet; powder for suspension; tablet; for suspension; suspension.
On the market
- Earliest approval on file
- August 6, 1984 Augmentin '250', Us Antibiotics; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 41 first March 14, 2002; 30 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 33 of which 31 under generic applications, 3 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.0693 per mL Amox-clav 600-42.9 mg/5 mL sus
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 5 since 2017 0 Class I among all firms' recalls; latest October 13, 2025
- FAERS reports
- 27,019 through July 30, 2026
What is amoxicillin and clavulanate used for?
From the label: indications and usageAmoxicillin and clavulanate potassium is indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below:
Lower Respiratory Tract Infections - caused by beta‑lactamase‑producing isolates of Haemophilus influenzae and Moraxella catarrhalis.
Acute Bacterial Otitis Media - caused by beta‑lactamase‑producing isolates of H. influenzae and M. catarrhalis.
Sinusitis - caused by beta‑lactamase‑producing isolates of H. influenzae and M. catarrhalis.
Skin and Skin Structure Infections - caused by beta‑lactamase‑producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species. […]
Conditions named in the indications of amoxicillin and clavulanate's FDA labels, with every medicine labeled for each:
From other amoxicillin and clavulanate labelsUrinary tract infections: Urinary Tract Infections - caused by beta‑lactamase‑producing isolates of E. coli, Klebsiella species, and Enterobacter species.
Bacterial infections: Amoxicillin and clavulanate potassium tablets USP is a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated in the treatment of infections due to susceptible isolates of the designated bacteria in the …
FDA pharmacologic class: Penicillin-class Antibacterial and beta Lactamase Inhibitor.
Source: FDA drug label (Amoxicillin and Clavulanate Potassium), Sandoz Inc, effective May 1, 2025 (SPL set 7cba82f0-9886-46e9-8dbd-43a448aade29), via openFDA; the full label on DailyMed
Is there a generic for amoxicillin and clavulanate (Augmentin)?
The FDA approved the first generic amoxicillin and clavulanate on March 14, 2002. 41 generic applications are approved; 30 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 and clavulanate from 31 labelers under a generic (ANDA) application and from 3 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1984 earliest approval on file
- 2002 first generic approved
- 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 and clavulanate (Augmentin)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0693 per mL (Amox-clav 600-42.9 mg/5 mL sus), up 2% from $0.0678 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. 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.
- Amox-clav 600-42.9 mg/5 mL sus (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Amox-clav 200-28.5 mg/5 mL sus | Generic | $0.0593 per mL | n/a | +3% |
| Amox-clav 250-125 mg tablet | Generic | $1.53 per tablet | $45.93 | +3% |
| Amox-clav 250-62.5 mg/5 mL sus | Generic | $0.435 per mL | n/a | +3% |
| Amox-clav 400-57 mg/5 mL suspension | Generic | $0.0658 per mL | n/a | -7% |
| Amox-clav 500-125 mg tablet | Generic | $0.253 per tablet | $7.60 | -20% |
| Amox-clav 600-42.9 mg/5 mL sus | Generic | $0.0693 per mL | n/a | +2% |
| Amox-clav 875-125 mg tablet | Generic | $0.284 per tablet | $8.52 | -0.6% |
| Amox-clav ER 1,000-62.5 mg tablet | Generic | $5.81 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $174.31 | -2% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has amoxicillin and clavulanate been recalled?
The FDA's Enforcement Report lists 5 recalls naming amoxicillin and clavulanate since 2017: 0 Class I (the most serious), 4 Class II, 1 Class III; 2 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| October 13, 2025 | Class II | Teva Pharmaceuticals USA, Inc | Subpotent drug; Clavulanate Potassium component |
| June 4, 2024 | Class II | Teva Pharmaceuticals USA, Inc | Subpotent Drug |
| February 7, 2020 | Class II | AuroMedics Pharma LLC | Presence of Foreign Substance: Customer complaint of a foreign substance identified as nylon cable tie |
| August 10, 2017 | Class II | Morton Grove Pharmaceuticals, Inc. | Presence of Foreign Substance: customer complaint of blue foreign material identified as a portion of a nitrile glove was discovered in product. |
| April 26, 2017 | Class III | Sandoz Inc | Subpotent Drug; Clavulanic Acid |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the amoxicillin and clavulanate label say about other medicines?
The amoxicillin and clavulanate label names 5 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Allopurinol | drug interactions | Co-administration with allopurinol increases the risk of rash. |
| Estradiol | drug interactions | Following administration of 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 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 | Co-administration with probenecid is not recommended. |
| Progesterone | drug interactions | Amoxicillin and clavulanate potassium may affect intestinal flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives. |
Source: FDA drug label (Amoxicillin and Clavulanate Potassium), Sandoz Inc, effective May 1, 2025 (SPL set 7cba82f0-9886-46e9-8dbd-43a448aade29), via openFDA; the full label on DailyMed
What do FAERS reports show for amoxicillin and clavulanate?
The FDA Adverse Event Reporting System holds 27,019 reports that list amoxicillin and clavulanate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2,605 are coded as a death and 13,277 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 and clavulanate?
19 other medicines are given the same way (oral) and in the same FDA class as amoxicillin and clavulanate or labeled mainly for the same use (urinary tract infections), the same class first. Urinary tract infections lists all 39 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 |
| Doxycycline | Bacterial infections, Urinary tract infections | 71 labelers | $0.118 per tablet 100 mg tablet | A presentation being discontinued |
| Cephalexin | Bacterial infections, Urinary tract infections | 36 labelers | $0.120 per capsule 500 mg capsule | No current entry |
| Nitrofurantoin | Bacterial infections, Urinary tract infections | 47 labelers | $0.165 per capsule 50 mg capsule | A presentation being discontinued |
| Minocycline | Urinary tract infections | 21 labelers | $0.343 per capsule 100 mg capsule | No current entry |
| Sulfamethoxazole and trimethoprim | Bacterial infections, Urinary tract infections | 42 labelers | $0.0448 per tablet Sulfamethoxazole-tmp ds tablet | No current entry |
| Levofloxacin | Bacterial infections, Urinary tract infections | 35 labelers | $0.259 per tablet 750 mg tablet | No current entry |
| Cefuroxime | Bacterial infections, Urinary tract infections | 17 labelers | $0.280 per tablet 250 mg tablet | No current entry |
Every medicine labeled for the same conditions as amoxicillin and clavulanate
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to amoxicillin and clavulanate
- 19 medicines for the same use
- Other penicillins
- the pharmacologic class, with prices and generics
- Amoxicillin and clavulanate side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other