FDA-approved Augmentin products in the United States include several prescription formulations containing amoxicillin and clavulanate potassium. The original brand family comprises conventional tablets, chewable tablets, standard oral suspensions, Augmentin XR extended-release tablets and Augmentin ES-600 pediatric suspension. These products have different FDA application records, labeled strengths and formulation characteristics. Generic amoxicillin/clavulanate products may also be approved through Abbreviated New Drug Applications, or ANDAs. Approval and therapeutic equivalence must be evaluated for the specific product rather than inferred from the shared ingredients or brand name.
On July 17, 2026, the FDA approved supplemental labeling changes that consolidated eight existing Augmentin New Drug Applications into one unified prescribing information document. The eight NDAs cover conventional tablets, two groups of chewable tablets, two groups of standard oral suspensions, XR and ES-600. The approval letter identifies each application and its associated strengths. This unified label is particularly useful for understanding the complete brand family, while the FDA Orange Book provides separate approval records, product numbers and applicable therapeutic-equivalence evaluations.
An FDA approval does not guarantee that a product is currently manufactured, marketed, stocked or covered by insurance. Orange Book records distinguish approved products and marketing classifications, while DailyMed provides product-specific labeling and package identifiers. Neither database functions as a live retail inventory service. This guide explains how to verify the regulatory identity and status of a particular Augmentin formulation. The Augmentin brand overview covers the medicine itself, and the generic manufacturers directory addresses individual ANDA holders and labeling companies.
The FDA's July 2026 unified prescribing information identifies five main Augmentin product families. Although all contain amoxicillin and clavulanate potassium, they are not universally interchangeable because their ingredient ratios, dosage forms and release characteristics differ.
Conventional immediate-release tablets contain 250 mg/125 mg, 500 mg/125 mg or 875 mg/125 mg of amoxicillin and clavulanic acid. Chewable tablets and standard oral suspensions are supplied in separate strength families, including 4:1 and approximately 7:1 amoxicillin-to-clavulanate ratios. Liquid strengths are expressed per 5 mL after reconstitution, not per tablet.
Augmentin XR is a distinct bilayer extended-release tablet containing 1,000 mg/62.5 mg. Augmentin ES-600 is a specialized pediatric powder for oral suspension containing 600 mg/42.9 mg per 5 mL after preparation. FDA labeling places specific substitution restrictions on these products.
The table identifies the principal branded formulations and their labeled strengths. It describes approved product categories rather than confirming which packages are currently marketed or available through a pharmacy.
Detailed product characteristics are available in the tablet guide, chewable guide, standard suspension guide, XR guide and ES-600 guide.
| Product family | FDA-labeled strengths | Dosage form | Regulatory distinction |
|---|---|---|---|
| Conventional Augmentin tablets | 250/125, 500/125 and 875/125 mg | Immediate-release tablets | Standard tablet products with separate strength records. |
| Augmentin chewable tablets | 125/31.25, 200/28.5, 250/62.5 and 400/57 mg | Chewable tablets | Separate chewable formulations. |
| Standard Augmentin suspension | 125/31.25, 200/28.5, 250/62.5 and 400/57 mg per 5 mL | Powder for oral suspension | Concentration-specific liquid products. |
| Augmentin XR | 1,000/62.5 mg | Extended-release bilayer tablets | Separate release profile and substitution restrictions. |
| Augmentin ES-600 | 600/42.9 mg per 5 mL | Powder for oral suspension | Distinct pediatric formulation and labeling. |
The FDA supplemental approval letter dated July 17, 2026, identifies eight existing Augmentin NDAs consolidated into one prescribing information document. This was a supplemental labeling approval, not the original approval date for every product in the family.
The conventional tablets are divided between NDA 050564, covering 250 mg/125 mg and 500 mg/125 mg, and NDA 050720, covering 875 mg/125 mg. The chewable products are covered by NDAs 050597 and 050726, while the standard suspension concentrations are covered by NDAs 050575 and 050725.
Two additional applications cover specialized products: NDA 050785 for Augmentin XR extended-release tablets and NDA 050755 for Augmentin ES-600 pediatric suspension. These remain separate regulatory identities even though their labeling is now presented within the unified document.
Each NDA may contain specific approved product entries and strengths. When verifying a medicine in the FDA database, the application number should be matched with its product number, dosage form and complete two-component strength. The table preserves all eight NDA and supplemental application identifiers.
| NDA | Augmentin product | FDA-labeled strengths | July 2026 supplement |
|---|---|---|---|
| 050564 | Conventional tablets | 250/125 and 500/125 mg | S-061 |
| 050720 | Conventional tablets | 875/125 mg | S-039 |
| 050597 | Chewable tablets | 125/31.25 and 250/62.5 mg | S-053 |
| 050726 | Chewable tablets | 200/28.5 and 400/57 mg | S-028 |
| 050575 | Standard oral suspension | 125/31.25 and 250/62.5 mg per 5 mL | S-053 |
| 050725 | Standard oral suspension | 200/28.5 and 400/57 mg per 5 mL | S-037 |
| 050785 | Augmentin XR | 1,000/62.5 mg extended-release tablet | S-022 |
| 050755 | Augmentin ES-600 | 600/42.9 mg per 5 mL | S-032 |
An NDA, or New Drug Application, identifies a regulatory application used for original branded and certain other new drug products. An ANDA, or Abbreviated New Drug Application, is generally used to approve a generic medicine that meets the FDA's applicable requirements for its reference product.
An appropriately approved generic amoxicillin/clavulanate product must satisfy relevant standards for active ingredients, strength, dosage form, route of administration, bioequivalence, labeling and manufacturing quality. Both active components matter: plain amoxicillin, which lacks clavulanate, is not a generic equivalent of Augmentin.
FDA approval is product-specific. A generic conventional 875 mg/125 mg tablet cannot be assumed equivalent to Augmentin XR, and a standard suspension generic cannot automatically replace ES-600. Different strengths and formulations require their own appropriate approval and equivalence relationships.
The Orange Book identifies NDA and ANDA records, approved product entries and therapeutic-equivalence evaluations where applicable. An A-rated generic is considered therapeutically equivalent within the relevant pharmaceutical-equivalence group; codes such as AB must be interpreted for the exact product. FDA approval does not establish present commercial distribution or pharmacy inventory.
For detailed equivalence and pharmacy-substitution explanations, see Augmentin vs generic. The generic manufacturers directory covers individual ANDA applicants without duplicating their company records here.
The FDA Orange Book and DailyMed answer different regulatory questions. The Orange Book identifies FDA-approved products, application numbers, product numbers, relevant marketing categories and therapeutic-equivalence evaluations. DailyMed publishes product-specific Structured Product Labeling, including active ingredients, dosage forms, warnings, labeler information and package NDCs.
A reliable search begins with amoxicillin and clavulanate potassium, followed by the complete strength pair and dosage form. The appropriate NDA or ANDA should then be located in the Orange Book. Searching only for Augmentin can miss generic products marketed under the established ingredient names.
The Orange Book Products data include application type, application number, product number, approval date, applicant, strength, dosage form, therapeutic-equivalence code and applicable reference-product designations. The FDA provides searchable records and downloadable data updated monthly. These fields distinguish an approved product from other formulations within the same family.
DailyMed can then be used to examine labeling details and NDC package identifiers. The named labeler may be a distributor or repackager rather than the original application holder. An NDC helps identify a listed product or package but is not itself proof of FDA approval, therapeutic equivalence or current supply.
Label revision dates also matter. The July 2026 unified FDA Augmentin prescribing information consolidates eight NDAs, while older standalone DailyMed labels may use different organization or earlier indication wording. Apparent differences should be evaluated using the relevant document dates rather than combined without verification.
This method provides a repeatable way to confirm product identity while separating regulatory evidence from commercial availability. Package appearance and authenticity questions are covered in the Augmentin product authenticity guide.
| Information needed | Primary source | What it establishes |
|---|---|---|
| FDA application and approval | Orange Book | NDA or ANDA and approved product records. |
| Complete strength and dosage form | Orange Book and FDA labeling | The specific formulation associated with the approval. |
| Therapeutic-equivalence evaluation | Orange Book | FDA's product-specific equivalence classification, where applicable. |
| Current Orange Book marketing category | Orange Book | The product's active or discontinued listing classification. |
| Warnings and labeling details | FDA prescribing information and DailyMed | Product-specific labeling content. |
| Labeler and package NDC | DailyMed | Identification of a listed product or package. |
| Current pharmacy stock | Dispensing pharmacy | Availability at the location and time checked. |
FDA approval and current commercial marketing are separate facts. A medicine can retain its regulatory approval even when the manufacturer no longer markets it. Likewise, an approved product appearing in an FDA database is not necessarily stocked by individual retail pharmacies.
The Orange Book includes prescription and over-the-counter product records as well as a Discontinued Drug Product List. A discontinued listing generally concerns marketing status and does not automatically indicate withdrawal for safety or effectiveness reasons. Such a conclusion requires the applicable FDA determination.
Historical FDA approvals, package NDCs, labeling revisions and market-entry announcements may establish important regulatory facts without demonstrating current retail distribution. Marketing records and actual pharmacy inventory must therefore be verified independently.
A current FDA record can be checked using the relevant Orange Book release, while a pharmacy can determine whether the actual branded or generic product is stocked or orderable. A supplier listing or published drug label should not be presented as a guarantee of availability.
The distinction is particularly important for specialized formulations such as Augmentin XR and ES-600, where a product's approval history, brand records and pharmacy supply may not align. The following status framework prevents these categories from being confused.
| Record or status | What it supports | What it does not prove |
|---|---|---|
| Approved NDA or ANDA | Regulatory approval of the identified drug product | Current production or pharmacy supply. |
| Active Orange Book listing | Current FDA listing classification | Guaranteed stock at a particular pharmacy. |
| Discontinued Orange Book listing | A discontinued marketing classification | Automatic withdrawal for safety reasons. |
| DailyMed label or NDC | Published labeling and package identification | Current retail distribution or FDA therapeutic equivalence. |
| Documented market-entry date | Historical entry into commercial marketing | That the product remains available today. |
| Pharmacy stock confirmation | Availability at the checked pharmacy and time | Permanent or nationwide availability. |
Augmentin XR is a separate extended-release product identified under NDA 050785. Its original FDA approval history dates to 2002, and the July 2026 unified labeling includes supplemental application S-022. Each tablet contains 1,000 mg of amoxicillin and 62.5 mg of clavulanic acid in a bilayer extended-release formulation.
On December 9, 2025, the FDA announced an approval associated with USAntibiotics and Augmentin XR through its Commissioner's National Priority Voucher pilot program. That announcement concerns a later regulatory event, not the product's first-ever approval. FDA authorized-generic records also document a December 15, 2025 market-entry date for an authorized generic XR product.
The July 2026 FDA labeling identifies branded XR bottles of 28 tablets, NDC 81964-020-28, and 40 tablets, NDC 81964-020-40. These package records confirm labeled product identities but do not demonstrate current pharmacy stock or nationwide distribution.
XR must not be treated as interchangeable with conventional immediate-release Augmentin tablets. The dosage form, component ratio and release mechanism differ, and generic-equivalence claims require XR-specific FDA evidence.
For detailed approval history, product characteristics and packaging, see the Augmentin XR product guide. The XR vs regular comparison explains the formulation differences.
Augmentin ES-600 is a separately approved pediatric suspension under NDA 050755. The July 2026 unified FDA labeling includes supplemental application S-032. The prepared product contains 600 mg of amoxicillin and 42.9 mg of clavulanic acid per 5 mL, with an approximately 14:1 ratio.
The July 2026 label specifies pediatric indication and patient-group requirements for ES-600 and distinguishes it from standard suspension formulations. The FDA also states that ES-600 is not substitutable with other Augmentin products.
Published DailyMed ES-600 records identify three labeled final prepared bottle volumes: 75 mL, 125 mL and 200 mL. Their corresponding NDCs are 81964-003-51, 81964-003-69 and 81964-003-54. These identifiers support package verification, not a claim that all configurations are currently stocked.
FDA approval of a generic standard amoxicillin/clavulanate suspension does not automatically establish equivalence to ES-600. The correct formulation and regulatory relationship must be verified independently.
The ES-600 product guide addresses its individual labeling and packaging, while ES-600 vs regular Augmentin explains the non-substitution boundary.
A practical verification starts by confirming that the medicine contains both amoxicillin and clavulanate potassium. Plain amoxicillin is a separate single-ingredient antibiotic and should not appear as a generic equivalent of Augmentin.
Next, establish the complete strength pair and dosage form. Conventional tablets, chewables, standard suspensions, XR and ES-600 must be distinguished before comparing FDA records. For suspensions, strength is expressed per 5 mL after reconstitution.
Locate the relevant NDA or ANDA in the Orange Book and confirm the associated product number. Where generic equivalence is relevant, review the product-specific therapeutic-equivalence information. Then consult FDA labeling or DailyMed for the appropriate product description and package identifiers.
Check the current Orange Book marketing classification separately from approval. A discontinued listing should not automatically be treated as a safety withdrawal, while an approved active listing should not be presented as proof of pharmacy inventory.
Finally, verify any actual prescription transaction directly with the dispensing pharmacy. The pharmacy must confirm that the intended product is available and may be lawfully dispensed under the prescription. Regulatory approval does not guarantee a particular cost, insurance benefit or substitute formulation.
This workflow is intended to keep the product catalog useful even when manufacturer relationships, marketing records and local supply conditions change.
Yes. Augmentin is an FDA-approved prescription medicine containing amoxicillin and clavulanate potassium. The branded family includes conventional tablets, chewable tablets, standard oral suspensions, XR extended-release tablets and ES-600 pediatric suspension.
The FDA's July 17, 2026 supplemental approval consolidates eight existing Augmentin NDAs into unified prescribing information: 050564, 050575, 050597, 050720, 050725, 050726, 050755 and 050785. These cover different product families and strengths.
NDA 050564 covers the 250 mg/125 mg and 500 mg/125 mg conventional tablet strengths. NDA 050720 covers the 875 mg/125 mg conventional tablet. The July 2026 supplements are S-061 and S-039, respectively.
Yes. The FDA identifies chewable strengths of 125/31.25, 200/28.5, 250/62.5 and 400/57 mg per tablet under NDAs 050597 and 050726. Their current pharmacy availability must be confirmed separately.
The July 2026 FDA labeling identifies standard concentrations of 125/31.25, 200/28.5, 250/62.5 and 400/57 mg per 5 mL. They are associated with NDAs 050575 and 050725. ES-600 is a separate pediatric suspension product.
Yes. Augmentin XR 1,000 mg/62.5 mg extended-release tablets are identified under NDA 050785. The product has an original approval history dating to 2002 and later regulatory activity, including the July 2026 unified labeling supplement.
Yes. Augmentin ES-600 is identified under NDA 050755. It is a specialized pediatric powder for oral suspension containing 600 mg of amoxicillin and 42.9 mg of clavulanic acid per 5 mL after reconstitution.
Yes. The FDA has approved generic amoxicillin/clavulanate products under specific ANDAs. Approval applies to identified strengths and dosage forms rather than every formulation containing the same two ingredients.
No. Plain amoxicillin lacks clavulanate potassium. Augmentin is a two-ingredient combination medicine, so single-ingredient amoxicillin is not its generic equivalent.
An NDA is a New Drug Application used for original branded and certain other new drug products. An ANDA is generally used for generic approval, requiring compliance with applicable pharmaceutical-equivalence, bioequivalence and quality requirements.
Use the FDA Orange Book to locate the exact approved product, strength and dosage form and review its applicable therapeutic-equivalence evaluation. A code for one formulation should not be assumed to apply to XR, ES-600 or another strength.
No. Regulatory approval does not guarantee current manufacturing, distribution or pharmacy stock. Marketing records and actual availability must be verified separately.
Not necessarily. The Orange Book discontinued classification can reflect an end to commercial marketing without a safety-related withdrawal. A specific FDA determination is required before attributing discontinuation to safety or effectiveness concerns.
No. DailyMed provides labeling information, and NDCs identify listed products or packages. FDA approval and any applicable therapeutic-equivalence relationship should be verified through the relevant regulatory application and Orange Book records.
The July 2026 XR labeling identifies 28-tablet NDC 81964-020-28 and 40-tablet NDC 81964-020-40. Published ES-600 labeling identifies 75 mL NDC 81964-003-51, 125 mL NDC 81964-003-69 and 200 mL NDC 81964-003-54. These records do not confirm current stock.
No. These are prescription-only antibiotics in the United States. FDA approval does not remove the requirement for a valid prescription or authorize independent substitution between distinct formulations.