Augmentin XR is a prescription extended-release antibiotic containing amoxicillin and clavulanate potassium. Each tablet contains 1,000 mg of amoxicillin and 62.5 mg of clavulanic acid, supplied as clavulanate potassium. Its bilayer formulation produces a different amoxicillin exposure profile from conventional immediate-release Augmentin tablets. The XR designation therefore identifies a specific drug product, not simply a higher-strength version of regular Augmentin or plain amoxicillin.
Augmentin XR has a distinct U.S. regulatory history. On December 9, 2025, the FDA announced an approval action associated with USAntibiotics through the Commissioner's National Priority Voucher pilot program. The agency subsequently described the decision as facilitating the product's relaunch and supporting domestic antibiotic manufacturing capacity. The July 2026 FDA prescribing information includes XR as a separately labeled formulation. These developments establish regulatory milestones, but neither an approval announcement nor a relaunch-related decision proves that a particular package is currently distributed or stocked by a U.S. pharmacy.
For someone reviewing an existing prescription, the practical task is to verify the exact Augmentin XR 1,000 mg/62.5 mg extended-release tablet, the actual approved product and the quantity a licensed pharmacy can dispense. FDA labeling identifies 28-tablet and 40-tablet branded packages, but package records are not live inventory data. XR also has specific indications and cannot be substituted with conventional Augmentin formulations merely by matching amoxicillin amounts. This page focuses on XR product identity, FDA status and pharmacy verification; the standard Augmentin tablets guide covers immediate-release products.
Augmentin XR is a branded extended-release combination of amoxicillin and clavulanate potassium. Amoxicillin interferes with bacterial cell-wall synthesis in susceptible organisms, while clavulanate inhibits certain beta-lactamase enzymes that can inactivate amoxicillin. The combination does not overcome every resistance mechanism and is not automatically preferable to other antibiotics.
The XR tablet uses a bilayer formulation that combines immediate-release and extended-release amoxicillin components. This design provides a concentration-time profile different from that of conventional immediate-release tablets. Its release technology is part of the approved product identity and cannot be reproduced by combining ordinary Augmentin tablets.
Each XR tablet contains 1,000 mg of amoxicillin and 62.5 mg of clavulanic acid, producing a 16:1 ingredient ratio. The clavulanic-acid amount is expressed as the acid equivalent supplied by clavulanate potassium. Both quantities identify one tablet, not an entire prescribed regimen. Conventional Augmentin tablets use different strength pairs and component ratios.
Augmentin XR is also distinct from plain amoxicillin because it contains clavulanate. A single-ingredient amoxicillin tablet or an immediate-release generic amoxicillin/clavulanate tablet should not be identified as XR solely because of a similar amoxicillin quantity.
The Augmentin brand overview introduces the broader product family, while the amoxicillin/clavulanate product guide explains the two-ingredient combination. This page concentrates on the extended-release formulation.
| Product characteristic | FDA-labeled information | Why it matters |
|---|---|---|
| Amoxicillin | 1,000 mg per XR tablet | Identifies the antibacterial component. |
| Clavulanic acid | 62.5 mg per XR tablet, supplied as clavulanate potassium | Identifies the beta-lactamase inhibitor component. |
| Ingredient ratio | 16:1 | Differs from conventional immediate-release tablet ratios. |
| Dosage form | Scored, film-coated bilayer extended-release tablet | Release characteristics are essential to product identity. |
| Labeled population | Adults and pediatric patients weighing at least 40 kg who can swallow tablets | Population-specific labeling requirements apply. |
| Prescription status | Prescription-only antibacterial medicine | Requires appropriate clinical prescribing and lawful dispensing. |
Augmentin XR has an established U.S. approval history under NDA 050785, with an original FDA approval date of September 25, 2002. That history is distinct from the later regulatory action announced in December 2025. The two milestones should not be described as though XR first entered the U.S. approval system in 2025.
On December 9, 2025, the FDA announced an Augmentin XR approval action through the Commissioner's National Priority Voucher pilot program, identifying USAntibiotics. The agency highlighted domestic antibiotic manufacturing and supply-chain resilience as important elements of the decision. Its announcement described accelerated review under the pilot pathway.
The FDA subsequently characterized the action as facilitating the relaunch of Augmentin XR. This establishes that the agency publicly connected its decision with renewed manufacturing and market-entry efforts. It does not independently document completion of nationwide distribution or confirm availability through particular wholesalers and community pharmacies.
The July 2026 consolidated prescribing information identifies XR as a separately labeled Augmentin product with specific indications, formulation characteristics and package descriptions. That label supplies product-identification information but should not be interpreted as a live commercial availability report.
The FDA-approved Augmentin products guide provides broader context about approval applications and regulatory records. The distinction between approval history and present commercial status is especially important for XR.
| Regulatory milestone | Documented event | Interpretation |
|---|---|---|
| September 25, 2002 | Original FDA approval associated with Augmentin XR NDA 050785 | Establishes the earlier regulatory history. |
| December 9, 2025 | FDA announced an Augmentin XR approval action associated with USAntibiotics | Documents a new regulatory milestone supporting domestic manufacturing. |
| FDA 2025 annual report | Described the action as facilitating an Augmentin XR relaunch | Does not by itself confirm completion of retail distribution. |
| July 2026 FDA prescribing information | Includes XR indications, formulation characteristics and package descriptions | Confirms labeled product details, not current pharmacy stock. |
FDA approval, active commercial marketing and pharmacy inventory describe different stages of a drug product's availability. Approval establishes the relevant regulatory authorization. Marketing concerns whether the product is being commercially distributed, while inventory concerns whether a specific pharmacy can actually supply it.
This distinction matters for Augmentin XR because its December 2025 approval was publicly connected with relaunch efforts. Regulatory support for renewed manufacturing does not establish that a particular XR package is available from every wholesaler or retailer. The correct interpretation requires dated evidence of the specific commercial status being discussed.
FDA approval records and the Orange Book can establish regulatory information, including product identities and application relationships. Published NDCs identify listed packages. Neither resource is a real-time pharmacy inventory system. Manufacturer or distributor communications can provide additional marketing context, while an actual dispensing pharmacy must confirm whether a prescribed product is available to fill.
Historical retailer listings may remain visible even when ordering is unavailable. Similarly, a licensed pharmacy may need to check its supplier before determining whether XR can be obtained. Without current verification, a website should distinguish the documented FDA approval and relaunch-related developments from unconfirmed present-day availability.
A responsible product listing therefore avoids statements such as 'available nationwide' or 'in stock' based solely on FDA approval. The Augmentin online pharmacy guide explains how to evaluate prescription-dispensing services and product listings.
The July 2026 FDA prescribing information identifies Augmentin XR for certain cases of community-acquired pneumonia and acute bacterial sinusitis caused by specified susceptible bacteria. These are product-specific indications rather than approval for every respiratory infection. The labeled population includes adults and pediatric patients weighing at least 40 kg who can swallow tablets.
The community-acquired pneumonia indication involves designated bacterial pathogens and applicable susceptibility conditions. XR's extended-release design does not make it a general replacement for every antibiotic used in pneumonia. The clinician must assess the suspected or confirmed organism, infection severity, treatment history and other relevant factors.
The acute bacterial sinusitis indication also depends on a bacterial cause and the conditions specified in the product label. Symptoms such as congestion or facial pressure do not independently establish a bacterial infection requiring Augmentin XR. Many respiratory illnesses are viral and do not benefit from antibacterial treatment.
The FDA states that XR is not indicated for community-acquired pneumonia or acute bacterial sinusitis caused by Streptococcus pneumoniae with penicillin minimum inhibitory concentrations of 4 mcg/mL or greater. This limitation is particularly relevant when interpreting claims about XR's higher amoxicillin content.
The labeled indications do not provide a patient-specific treatment recommendation. Augmentin XR must be prescribed after appropriate clinical assessment, and its approved uses should not be generalized to other Augmentin formulations.
| FDA-labeled context | Relevant population | Important limitation |
|---|---|---|
| Community-acquired pneumonia | Adults and pediatric patients weighing at least 40 kg who can swallow tablets | Restricted to specified bacterial pathogens and susceptibility conditions. |
| Acute bacterial sinusitis | Adults and pediatric patients weighing at least 40 kg who can swallow tablets | Not a general indication for viral or nonbacterial respiratory symptoms. |
| Specified S. pneumoniae infections with penicillin MIC of at least 4 mcg/mL | Outside the stated XR indication | FDA labeling identifies this susceptibility restriction. |
The July 2026 FDA prescribing information describes branded Augmentin XR as a white, oval, scored, film-coated bilayer extended-release tablet debossed with AUGMENTIN XR. These characteristics identify the described branded presentation and should not be applied automatically to unrelated amoxicillin/clavulanate products.
The label identifies two branded package configurations: 28 tablets, described as a seven-day XR pack, and 40 tablets, described as a ten-day XR pack. Both contain the same individual 1,000 mg/62.5 mg extended-release tablet. Their package names reflect labeled presentations rather than instructions for an individual patient to select a treatment duration.
The corresponding NDCs are 81964-020-28 for the 28-tablet package and 81964-020-40 for the 40-tablet package. These are package identifiers, not evidence of current stock or proof that the associated packages are being distributed through all commercial channels.
A generic, authorized-generic or repackaged product may have different labeling and package identifiers. Patients reviewing a pharmacy offer should verify the actual product, labeler, dosage form and dispensing quantity rather than assigning a branded NDC to every product described as extended-release amoxicillin/clavulanate.
The Augmentin product authenticity guide explains broader identification methods. This section is limited to XR-specific branded markings and package records.
| FDA-labeled package | NDC | Quantity | Verification note |
|---|---|---|---|
| Augmentin XR seven-day pack | 81964-020-28 | 28 tablets | FDA-described branded package; current availability requires confirmation. |
| Augmentin XR ten-day pack | 81964-020-40 | 40 tablets | Separate package configuration with the same individual XR tablet strength. |
The FDA specifically states that Augmentin XR is not substitutable with conventional immediate-release Augmentin formulations. The distinction involves both the different amoxicillin release profile and the quantities of the two active components. The complete strength pair matters more than a superficially matching amoxicillin total.
For example, one XR tablet contains 1,000 mg of amoxicillin and 62.5 mg of clavulanic acid. Two conventional 500 mg/125 mg Augmentin tablets contain a combined 1,000 mg of amoxicillin but 250 mg of clavulanic acid. Their clavulanate content differs, and the conventional tablets do not reproduce the XR release characteristics.
The conventional 875 mg/125 mg tablet is also distinct from XR. It contains a different amount of both components and uses immediate-release technology. A similar brand name, tablet appearance or total amoxicillin quantity does not establish therapeutic interchangeability.
FDA provisions for certain substitutions among conventional tablets, chewables and standard oral suspensions do not extend automatically to XR. Augmentin ES-600 is another separately labeled formulation with its own non-substitution restrictions. If the prescribed XR product is unavailable, an appropriate professional must evaluate any proposed alternative.
The Augmentin 500/125 mg guide and Augmentin 875/125 mg guide address those conventional tablet strengths. The Augmentin ES-600 guide covers the separate pediatric suspension.
| Product | Amoxicillin | Clavulanic acid | Key distinction |
|---|---|---|---|
| One Augmentin XR tablet | 1,000 mg | 62.5 mg | Extended-release bilayer tablet. |
| Two conventional Augmentin 500/125 mg tablets | 1,000 mg combined | 250 mg combined | Not equivalent to one XR tablet despite matching the amoxicillin total. |
| One conventional Augmentin 875/125 mg tablet | 875 mg | 125 mg | Different immediate-release strength and component ratio. |
The phrase generic Augmentin XR requires product-specific verification. An independently approved generic extended-release amoxicillin/clavulanate product must meet the applicable FDA requirements for its reference product, dosage form and strength. A conventional generic combination tablet is not an XR equivalent simply because both contain amoxicillin and clavulanate.
FDA Orange Book records can be used to examine approved extended-release products and applicable therapeutic-equivalence information. Historical extended-release generic approval records should not be presented as proof that a specific generic is currently marketed or available through a chosen pharmacy.
An authorized generic is distinct from an independently approved generic under an Abbreviated New Drug Application. An authorized generic is marketed under an approved brand NDA without using the brand name, whereas an ANDA generic has its own application. The actual product records establish which category applies.
Manufacturer, application holder, labeler and repackager identities may differ. An NDC can help identify a listed package but does not independently establish approval or availability. A pharmacy should verify the exact product and permitted substitution rather than relying on an abbreviated generic search term.
The FDA-approved Augmentin products guide covers approval relationships, while the generic manufacturers directory addresses company and labeler records. Neither source should be treated as a substitute for current pharmacy inventory confirmation.
Augmentin XR has specific administration requirements associated with its extended-release design. The July 2026 FDA labeling instructs that XR be taken at the start of a meal. This supports the intended absorption profile and may reduce gastrointestinal intolerance. A high-fat meal is not recommended because it can reduce clavulanate absorption.
The label directs that XR tablets generally be taken whole. For patients who have difficulty swallowing them, the scored tablet may be split along the score line, provided both halves are taken immediately. This provision does not authorize crushing the tablet, saving one half for later or reducing the prescribed amount independently.
XR is labeled for adults and pediatric patients weighing at least 40 kg who can swallow tablets. The existence of a score line does not make XR suitable for patients outside that labeled population or remove the need for appropriate clinical assessment.
The FDA specifies storage of XR tablets at or below 25°C (77°F). Refrigeration and the ten-day discard rule apply to reconstituted Augmentin oral suspensions, not automatically to XR tablets. The dispensing label and actual product packaging should be followed.
Patients who cannot swallow XR or have questions about meal timing should discuss the issue with their clinician or pharmacist. They should not independently exchange XR for an immediate-release product or alter tablet administration.
Augmentin XR is a prescription-only medicine. A licensed U.S. pharmacy must process a valid prescription and confirm that the intended product is an extended-release amoxicillin/clavulanate tablet rather than conventional Augmentin or plain amoxicillin.
The complete product identity includes 1,000 mg of amoxicillin, 62.5 mg of clavulanic acid and the XR dosage form. The pharmacy should also verify the actual product name, manufacturer or labeler, dispensing quantity and NDC where applicable. If a generic alternative is proposed, its approval relationship and applicable substitution requirements must be established.
Current supply requires a separate check. The FDA's December 2025 announcement and July 2026 prescribing information document regulatory facts but do not confirm that a selected pharmacy can supply the 28-tablet or 40-tablet branded package. The pharmacy may need to review current inventory or supplier ordering information.
If XR cannot be obtained, the patient should seek professional guidance rather than replacing the prescription with conventional Augmentin tablets, oral suspension or leftover antibiotics. The FDA's non-substitution warning is relevant even when the nominal amoxicillin amounts appear similar.
For broader prescription-based purchasing questions, see the U.S. Augmentin buying guide and Augmentin online pharmacy guide. Neither a catalog listing nor a regulatory approval establishes guaranteed stock, delivery or prescription approval.
| Verification point | What to confirm | Reason |
|---|---|---|
| Valid prescription | Existing prescription for the intended antibacterial product | XR is not available over the counter. |
| Product name | Augmentin XR or an appropriately verified extended-release product | Separates XR from regular Augmentin. |
| Complete strength | 1,000 mg amoxicillin / 62.5 mg clavulanic acid | Both quantities identify the formulation. |
| Release type | Extended-release tablet | Immediate-release products are not interchangeable. |
| Product and package identifiers | Actual manufacturer or labeler, quantity and NDC | Supports accurate identification of the dispensed medicine. |
| Current availability | Pharmacy inventory or ordering confirmation | FDA approval alone does not establish stock. |
| Substitution restrictions | Applicable FDA labeling and professional review | Prevents inappropriate formulation changes. |
Augmentin XR contains amoxicillin, a penicillin-class antibacterial, and is subject to the FDA contraindications involving serious hypersensitivity reactions to Augmentin or other beta-lactam antibacterial drugs. A history of Augmentin-associated cholestatic jaundice or hepatic dysfunction is another labeled contraindication.
Reported adverse reactions include diarrhea, nausea, vomiting and skin reactions. Serious risks described in the prescribing information include anaphylaxis, severe cutaneous adverse reactions, liver injury and Clostridioides difficile-associated diarrhea. Sudden breathing difficulty or swelling of the face or throat requires emergency medical attention.
The FDA labeling identifies interactions or precautions involving medications such as probenecid, oral anticoagulants and allopurinol. It also establishes an important XR-specific renal restriction: patients with severe renal impairment or those receiving intermittent hemodialysis should not receive Augmentin XR Extended-Release Tablets. This differs from the dosage-adjustment framework for certain conventional Augmentin formulations. The XR formulation and strength do not eliminate the need for professional review of individual contraindications, interactions and precautions.
Readers seeking more information about beta-lactam hypersensitivity can consult the penicillin allergy guide. This page provides general product and safety information, not personalized medical advice.
An Augmentin XR price cannot be inferred from FDA approval records or the December 2025 relaunch-related announcement. Actual out-of-pocket cost may depend on the product, dispensing quantity, pharmacy, insurance benefits and available discounts. Historical offers should not be represented as current retail prices without dated verification.
The FDA-labeled 28-tablet and 40-tablet packages have different quantities, but their seven-day and ten-day descriptions do not establish a universal prescription duration or current retail offer. A meaningful price comparison should identify the actual package or dispensing quantity and the medicine being supplied.
Generic availability also requires verification. A historical extended-release generic approval is not evidence that a particular generic is currently marketed or less expensive at a selected pharmacy. Approval, commercial distribution, therapeutic equivalence and pharmacy inventory are separate questions.
The Augmentin price guide covers broader branded cost information, while the Augmentin insurance coverage guide addresses benefit and formulary questions. This page does not promise prices, insurance reimbursement, prescription approval or immediate delivery.
Augmentin XR is a prescription extended-release tablet containing amoxicillin and clavulanate potassium. Each tablet provides 1,000 mg of amoxicillin and 62.5 mg of clavulanic acid. Its bilayer extended-release formulation differs from conventional Augmentin tablets.
Yes. Augmentin XR has an FDA approval history dating to 2002. On December 9, 2025, the FDA announced a further approval action associated with USAntibiotics through its Commissioner's National Priority Voucher pilot program. The July 2026 prescribing information includes XR.
The FDA described its December 2025 approval action as facilitating an Augmentin XR relaunch. This documents a regulatory milestone supporting renewed manufacturing and distribution efforts. It does not independently establish that nationwide retail distribution was completed.
Current availability must be confirmed with a licensed pharmacy. FDA approval, published NDCs and the 2025 relaunch-related announcement do not establish real-time inventory or guarantee that a particular branded XR package can be supplied.
Each tablet contains 1,000 mg of amoxicillin and 62.5 mg of clavulanic acid, supplied as clavulanate potassium. The complete strength pair identifies the two-component extended-release product.
Augmentin XR uses a bilayer extended-release formulation and has different component proportions from conventional immediate-release Augmentin tablets. It also has specific FDA-labeled indications and substitution restrictions. The products should not be exchanged independently.
No. Two conventional 500/125 mg tablets provide 1,000 mg of amoxicillin but 250 mg of clavulanic acid. One XR tablet provides 1,000 mg of amoxicillin and 62.5 mg of clavulanic acid, with different release characteristics. FDA labeling identifies XR as not substitutable with immediate-release formulations.
The July 2026 FDA prescribing information identifies XR for specified cases of community-acquired pneumonia and acute bacterial sinusitis caused by susceptible bacteria. The indications have organism and susceptibility restrictions and do not apply to every respiratory illness.
FDA labeling identifies adults and pediatric patients weighing at least 40 kg who can swallow tablets. The medicine must still be prescribed following appropriate clinical assessment.
The July 2026 FDA label describes a white, oval, scored, film-coated bilayer extended-release tablet debossed with AUGMENTIN XR. Tablet identification should be confirmed against the actual dispensing label and product information.
FDA labeling permits splitting XR tablets along the score line when swallowing the tablet whole is difficult, provided both halves are taken immediately. This does not authorize crushing the tablet, saving a half for later or independently reducing a prescribed amount.
The FDA labeling instructs that XR be taken at the start of a meal and advises against taking it with a high-fat meal because clavulanate absorption may be reduced. Patients should follow their prescribed administration instructions.
The July 2026 FDA label identifies a 28-tablet package with NDC 81964-020-28 and a 40-tablet package with NDC 81964-020-40. These records do not establish whether either package is currently stocked by a selected pharmacy.
FDA records include historical approval information for generic extended-release amoxicillin/clavulanate products. Whether a specific generic is currently marketed, appropriately therapeutically equivalent and available at a pharmacy must be verified through product-specific records.
No. XR is an extended-release tablet containing 1,000 mg/62.5 mg per tablet, while ES-600 is a specialized pediatric oral suspension containing 600 mg/42.9 mg per 5 mL. Their formulations, labeled populations and substitution restrictions differ.
No. Augmentin XR is a prescription-only antibacterial medicine in the United States. Lawful dispensing requires a valid prescription and compliance with applicable pharmacy requirements. An online listing does not establish prescription-free access.
Confirm the complete 1,000 mg/62.5 mg strength pair, extended-release dosage form, actual product name, manufacturer or labeler, dispensing quantity and relevant NDC. Ask the pharmacy to verify current supply and ensure the medicine matches the prescription.
Augmentin XR contains amoxicillin, a penicillin-class antibacterial. Its FDA labeling contraindicates use in patients with a history of serious hypersensitivity reactions to Augmentin or other beta-lactam antibacterial drugs. A reported allergy requires professional evaluation before prescribing.