Amoxicillin/clavulanate generic manufacturers can be identified through U.S. FDA approval records, but the company named on a pharmacy package is not necessarily the company that holds the drug's approval or physically manufactures it. The FDA Orange Book identifies approved drug products, application holders, dosage forms, strengths and applicable therapeutic-equivalence information. DailyMed supplies product labeling that may identify a labeler, distributor, manufacturing establishment, package configuration and National Drug Code. These records serve different purposes and must be reconciled before describing a company as an Augmentin generic manufacturer.
The U.S. generic amoxicillin/clavulanate category includes multiple pharmaceutical forms: conventional immediate-release tablets, chewable tablets, powders for standard oral suspension and historically approved extended-release products. Each dosage form has its own strength pairs and regulatory relationships. An approved generic 875 mg/125 mg immediate-release tablet is not automatically equivalent to a chewable product, a liquid concentration or Augmentin XR. Likewise, plain amoxicillin manufacturers should not be included in an amoxicillin/clavulanate directory merely because they supply products containing amoxicillin.
This directory explains how to identify genuine FDA application records and provides documented examples from U.S. product labeling, including Aurobindo Pharma, Teva Pharmaceuticals USA and other labelers appearing in DailyMed. It separates verified product-specific records from questions about current marketing, pharmacy stock or commercial distribution. Its purpose is regulatory identification rather than choosing an antibiotic, recommending a manufacturer or comparing retail offers. For broader information about the combination medicine and its formulations, see the amoxicillin/clavulanate product guide.
An FDA-approved drug product can be associated with several companies performing different functions. The application holder is the entity with legal responsibility for the approved New Drug Application or Abbreviated New Drug Application. The physical manufacturer operates a facility involved in making the drug or carrying out specified manufacturing steps. A distributor may market or supply the finished product, while a labeler is the company identified in the drug-listing record.
These roles can overlap but should not be treated as synonyms. One company may hold an ANDA and manufacture the drug, while another company distributes or repackages it under its own labeling. A patient-facing NDC may therefore identify a repackaged or relabeled product rather than the original FDA application holder.
The Orange Book identifies the responsible applicant for the approved drug product. Its applicant name field may use an abbreviated company name, and the downloadable data also include an applicant full-name field. DailyMed labeling can add a different perspective through product-specific labeler, manufacturing, packaging and establishment information.
An accurate generic-manufacturer directory should describe the role supported by each record. For example, a company found in a DailyMed field labeled Packager should not automatically be described as the original manufacturer. Similarly, the existence of an ANDA approval does not confirm that a specific manufacturing establishment is currently producing that product.
This distinction matters for product verification because an approved medicine may appear under more than one package identifier or commercial name. The Augmentin product authenticity guide covers related checks involving package labels, imprints and identification records.
| Entity or identifier | Primary information source | What the record establishes | What it does not establish |
|---|---|---|---|
| ANDA holder | FDA Orange Book application record | The applicant legally responsible for the approved generic application. | The physical location where every marketed package was manufactured. |
| Manufacturing establishment | Product labeling and relevant FDA establishment records | The manufacturing or processing role identified in the available record. | That the establishment currently manufactures every listed product. |
| Labeler or packager | DailyMed and drug-listing records | The entity associated with the published labeled product or package. | That the entity owns the corresponding ANDA. |
| Distributor | Product labeling | A company identified with distribution of the specified product. | That the distributor independently manufactures the medicine. |
| NDC | Published package and drug-listing information | A product or package-specific identification code. | FDA approval, authenticity or real-time pharmacy inventory by itself. |
The FDA Orange Book is the primary regulatory starting point for identifying approved generic amoxicillin/clavulanate products. Searches should use both active ingredients and should distinguish conventional tablets, chewable tablets, powders for suspension and extended-release formulations. Searching only for amoxicillin can return unrelated single-ingredient products.
The Orange Book product data identify the ingredient combination, dosage form and route, trade name, applicant, strength, application type, application number and product number. The application type distinguishes NDA products from ANDA products. Therapeutic-equivalence codes, where assigned, provide additional information about the FDA's equivalence evaluation for a specific approved drug product.
An ANDA number belongs to an application, which may contain multiple product entries for different approved strengths. Therefore, one company and one application can appear across more than one strength. Counting each strength as a separate manufacturer would artificially inflate the directory.
The FDA supplies a searchable electronic Orange Book and downloadable products data updated on a regular schedule. The files are suitable for constructing a reproducible directory because the applicant, application number, product number, dosage form and strength can be retained as separate structured fields.
Orange Book results also require correct interpretation of current and discontinued product lists. A product appearing in a discontinued listing should not be described as currently marketed. Conversely, a current approval entry should not be treated as a promise that a particular pharmacy has the medicine available for dispensing.
For detailed product approval context, consult the FDA-approved Augmentin products guide. This directory focuses on identifying companies and linking them to the specific applications and dosage forms supported by regulatory records.
U.S. DailyMed records identify several companies associated with amoxicillin/clavulanate generic products. The examples below illustrate different regulatory and labeling roles rather than providing an exhaustive list of all approved ANDA holders. Their inclusion does not constitute a ranking by product quality, market share, current supply or pharmacy availability.
Aurobindo Pharma Limited appears in DailyMed records for conventional amoxicillin/clavulanate tablets and for oral suspension. Its September 2026 suspension labeling identifies ANDA 201090 for 200 mg/28.5 mg and 400 mg/57 mg per 5 mL formulations. The same labeling distinguishes Aurobindo Pharma Limited as the labeler and manufacturer from Aurobindo Pharma USA, Inc. as the U.S. distributor.
Teva Pharmaceuticals USA appears in DailyMed records for amoxicillin/clavulanate tablets, oral suspension and chewable products. Product-specific records must be reviewed before assigning particular applications or manufacturing roles to Teva. For example, a Teva-labeled 400 mg/57 mg per 5 mL suspension record identifies ANDA 065089.
Dr. Reddy's Laboratories Inc. and Sandoz Inc. also appear in DailyMed labeling records for amoxicillin/clavulanate conventional tablets and oral suspensions. Their inclusion here establishes documented label or packager associations with the combination medicine, not that every listed strength is currently stocked or that all products share one application holder.
Chartwell RX, LLC illustrates why company roles must be separated. A September 2026 DailyMed label lists Chartwell RX as the packager for conventional tablets, suspensions and chewable tablets. Several products on that label have distinct underlying ANDA numbers, so the presence of one packager name does not establish ownership of every referenced approval.
These examples are intentionally limited to records that identify both the two-ingredient combination and the relevant company role. They should be rechecked against current Orange Book and DailyMed data before an exhaustive applicant directory or manufacturer-specific commercial inventory is published.
| Company | Documented role or association | Example product evidence | Scope limitation |
|---|---|---|---|
| Aurobindo Pharma Limited | DailyMed labeler; manufacturing role documented in selected product records | Conventional tablets and standard oral suspensions; suspension ANDA 201090 for the 200/28.5 and 400/57 mg per 5 mL family | The approval and manufacturing relationship must be checked for each product and strength. |
| Teva Pharmaceuticals USA, Inc. | DailyMed product labeler | Amoxicillin/clavulanate combination formulations; 400/57 mg per 5 mL suspension associated with ANDA 065089 | Labeler identity does not prove current supply or the physical manufacturer of every presentation. |
| Sandoz Inc. | DailyMed packager or labeler association | Conventional tablets and oral suspension records | Specific current application-holder and manufacturing roles require product-level confirmation. |
| Dr. Reddy's Laboratories Inc. | DailyMed packager or labeler association | Conventional tablets and oral suspension records | Not an assertion that every historically listed product is currently marketed. |
| Chartwell RX, LLC | DailyMed packager | Combined label covering conventional tablets, standard suspensions and chewable tablets | The package company should not automatically be treated as the owner of the underlying ANDAs. |
| Preferred Pharmaceuticals Inc. | DailyMed repackager | Repackaged amoxicillin/clavulanate suspension with a separately identified source NDC | Repackaging does not create an independent generic approval for the original drug product. |
Conventional immediate-release amoxicillin/clavulanate tablets are a major category within the U.S. generic market. Standard strength pairs include 250 mg/125 mg, 500 mg/125 mg and 875 mg/125 mg. Each strength contains separate quantities of the two active ingredients, so a manufacturer record should identify the complete pair rather than amoxicillin alone.
DailyMed provides concrete examples of generic tablet labeling associated with Aurobindo Pharma Limited and other companies. A September 2026 Aurobindo label identifies conventional film-coated tablets under NDC product families beginning 65862-501, 65862-502 and 65862-503. Those package identifiers are useful for verification, but the exact strength, package and application relationship must be checked in the underlying record.
Tablet products associated with Teva, Sandoz and Dr. Reddy's also appear in DailyMed records. The presence of several labelers in a product category does not imply that their pills have identical markings or package sizes. An approved generic may differ from the original Augmentin brand in appearance and inactive ingredients within applicable FDA requirements.
A proper directory groups tablet records by ANDA holder and application number, then shows individual strength entries and their associated labelers. If a repackager has a different NDC for a tablet sourced from an approved manufacturer, the repackager should be recorded as a separate packaging entity rather than automatically counted as another drug manufacturer.
The Augmentin tablets guide covers the broad product family. Dedicated pages for 250/125 mg, 500/125 mg and 875/125 mg address individual tablet identities, while the present page concentrates on the companies and records associated with their generic equivalents.
Chewable amoxicillin/clavulanate products have distinct strength pairs and dosage-form characteristics. The conventional FDA-labeled chewable strengths are 125 mg/31.25 mg, 200 mg/28.5 mg, 250 mg/62.5 mg and 400 mg/57 mg per tablet. These strengths should not be collapsed into the conventional film-coated tablet category.
The distinction is important because chewable products can have different ingredient ratios and inactive ingredients from ordinary tablets. For example, a conventional 250 mg/125 mg Augmentin tablet contains twice as much clavulanic acid as a 250 mg/62.5 mg chewable tablet. Matching the 250 mg amoxicillin quantity therefore does not establish equivalence.
A September 2026 DailyMed label associated with Chartwell RX includes chewable products containing 200 mg/28.5 mg and 400 mg/57 mg, identified under NDC families 62135-104 and 62135-105. The label references ANDA 065205 for these chewable presentations. This is an example of how a package label can expose an underlying approved application without proving that the packager is its legal holder.
The company name appearing on a chewable package may be different from the name in an Orange Book ANDA record. A directory should preserve the original approval relationship and separately record the packager or relabeler. This is especially important when a historical chewable product has appeared under more than one commercial label.
Manufacturing and labeling information must be verified for each strength and product version. Chewable tablets may differ in flavor, coloring, sweeteners or imprints, so the exact product label is relevant to pharmacy verification.
The Augmentin chewable tablets guide provides the form-specific strength and excipient comparison. This directory intentionally focuses on the regulatory companies and application records rather than repeating chewable product-selection information.
Generic oral suspensions are supplied as powder for reconstitution and must be identified by the quantities of both active components per 5 mL of prepared liquid. Standard concentration pairs include 125 mg/31.25 mg, 200 mg/28.5 mg, 250 mg/62.5 mg and 400 mg/57 mg per 5 mL. The concentrations have different component ratios and should be recorded separately from package volume.
Aurobindo Pharma Limited provides a documented example of a generic suspension manufacturer and labeler. Its September 2026 DailyMed record identifies ANDA 201090 for the 200 mg/28.5 mg and 400 mg/57 mg per 5 mL concentrations and names Aurobindo Pharma Limited in the manufacturing establishment information. The same record identifies Aurobindo Pharma USA, Inc. as the distributor.
The Aurobindo record lists NDC 65862-533 for the 200 mg/28.5 mg per 5 mL product family and NDC 65862-534 for the 400 mg/57 mg per 5 mL product family. Separate package suffixes identify final bottle configurations, including 50 mL, 75 mL and 100 mL presentations. These identifiers demonstrate the difference between a formulation's approval identity and its packaged product records.
Teva-labeled amoxicillin/clavulanate suspensions also appear in DailyMed. For example, a 400 mg/57 mg per 5 mL product is listed with ANDA 065089 and an NDC beginning 0093-2279. Sandoz and Dr. Reddy's have additional published combination-suspension records. Each needs product-level confirmation before assigning current manufacturing or distribution status.
A repackaged liquid may carry a different NDC from its original source product. DailyMed can expose this relationship through a source NDC field, allowing the directory to separate the repackager from the original product listing. The same principle applies to other dosage forms.
The Augmentin oral suspension guide owns the detailed discussion of liquid concentrations, reconstitution, storage and pediatric handling. This regulatory directory focuses on the companies, ANDAs and labels associated with those products.
| Documented product record | Application or identifier | Dosage form and strength | Important distinction |
|---|---|---|---|
| Aurobindo Pharma Limited | ANDA 201090; NDC family 65862-533 | Oral suspension 200 mg/28.5 mg per 5 mL | Published label identifies Aurobindo as labeler and manufacturer. |
| Aurobindo Pharma Limited | ANDA 201090; NDC family 65862-534 | Oral suspension 400 mg/57 mg per 5 mL | Same documented application with a different product strength. |
| Teva Pharmaceuticals USA, Inc. | ANDA 065089; NDC family 0093-2279 | Oral suspension 400 mg/57 mg per 5 mL | Published labeler and application association; current inventory not established. |
| Chartwell RX, LLC | Packager with product-specific underlying ANDAs | Conventional tablets, suspensions and chewables | Package role must be separated from the original ANDA holder. |
Extended-release amoxicillin/clavulanate is a separate regulatory product category from conventional immediate-release tablets. The Augmentin XR reference product is labeled at 1,000 mg of amoxicillin and 62.5 mg of clavulanic acid per extended-release tablet. Its release characteristics and ingredient ratio prevent generic approval records for ordinary tablets from being interpreted as XR equivalents.
FDA records include historical approvals for extended-release amoxicillin/clavulanate products. Such records must be reviewed through the relevant NDA or ANDA, dosage form, strength and therapeutic-equivalence information. An extended-release generic application should not be grouped with immediate-release tablet approvals merely because the established ingredients are identical.
The regulatory history of Augmentin XR also includes the FDA's December 2025 approval action associated with USAntibiotics and a relaunch-related manufacturing initiative. That decision is separate from historical generic approvals. Neither event establishes present pharmacy inventory or that a particular XR generic is actively distributed.
A directory should list an extended-release generic only when the relevant application relationship can be verified. If the marketing status is not confirmed, the record should be identified as an approved or historical regulatory entry rather than a currently stocked generic manufacturer.
The Augmentin XR product guide owns the detailed explanation of extended-release formulation, FDA status and relaunch history. This manufacturer directory addresses the corresponding company and approval-record classification.
Augmentin ES-600 is a distinct pediatric oral suspension containing 600 mg of amoxicillin and 42.9 mg of clavulanic acid per 5 mL after reconstitution. Its approximately 14:1 ingredient ratio differs from the standard suspension families. It should not be grouped with ordinary amoxicillin/clavulanate liquid concentrations without identifying the separate product.
FDA labeling explicitly states that ES-600 is not substitutable with other Augmentin or Augmentin XR formulations. This restriction remains relevant when reviewing generic product records. A company that lists a standard 400 mg/57 mg per 5 mL oral suspension has not, by that fact alone, established an approved generic equivalent to ES-600.
Product-specific application records must support any statement about a generic ES-600 formulation. The existence of a company manufacturing standard amoxicillin/clavulanate suspension does not prove approval for ES-600 or present distribution of a corresponding product.
The Augmentin ES-600 product guide explains that formulation's distinct FDA labeling. The separate ES-600 vs regular Augmentin comparison covers the formulation differences. This directory preserves ES-600 as a distinct approval category instead of treating it as another ordinary suspension strength.
The most reliable way to identify a generic company's role is to reconcile the FDA application record with the product's published labeling. The Orange Book establishes the approved applicant and product entry. DailyMed can provide the displayed drug name, product strength, labeler, NDC, packaging and sometimes manufacturing-establishment information.
Begin with the complete two-component drug name and dosage form rather than a company search alone. An applicant may hold approvals for plain amoxicillin as well as amoxicillin/clavulanate; those products belong to different regulatory categories. The correct combination product must contain both amoxicillin and clavulanate potassium.
The next check is the application number and product-specific strength. An ANDA may cover multiple strengths, and a DailyMed label may include multiple dosage forms or products under one published document. The application reference should be matched to the correct product entry rather than attributed broadly to every strength shown on a label.
The labeler's NDC is then useful for identifying the particular commercial package. The NDC does not replace the Orange Book application record, and a repackager's identifier does not automatically designate the original drug manufacturer. If a source NDC is given, that field can help identify the underlying product relationship.
For a maintained regulatory directory, the minimum useful record includes a source verification date, ANDA number, product number, application holder, dosage form, complete strength, labeler, NDC and any documented manufacturing or repackaging role. Fields that cannot be verified should remain unassigned rather than completed by inference.
This method helps distinguish regulatory evidence from promotional claims. A manufacturer website, online pharmacy listing or marketplace product page can contain commercial information, but product-specific FDA records remain the appropriate foundation for approval and identity claims.
| Directory field | Primary source | Required interpretation |
|---|---|---|
| Application number | FDA Orange Book | Identifies the NDA or ANDA associated with the approved product. |
| Product number | FDA Orange Book | Distinguishes approved product entries under an application. |
| ANDA holder | FDA Orange Book applicant field | Identifies the legally responsible applicant. |
| Dosage form and strength | Orange Book and DailyMed | Must identify both active components and the relevant formulation. |
| Labeler | DailyMed drug-listing record | Identifies the entity associated with the published labeled product. |
| Manufacturer or establishment | Documented establishment or product-label information | Record only the specific manufacturing role supported by the source. |
| NDC and package | DailyMed package section | Identifies the relevant listed product or package, not current stock. |
| Verification date | Editorial record of the source review | Allows changes in approval, labeling and marketing information to be tracked. |
An approved ANDA and a marketed pharmacy product are not the same thing. The FDA may approve a generic product that is not currently distributed, and a historically marketed product may later be discontinued or transferred to another company. A regulatory directory should distinguish approval status from commercial marketing status wherever the available records support that distinction.
The Orange Book includes current and discontinued product information. DailyMed labels may display marketing start dates and, where applicable, marketing end dates. These fields help explain a product's documented labeling history, but they do not independently prove that a manufacturer has finished goods available for wholesale distribution on a given day.
A company may also remain associated with an older label after corporate changes, transfers or repackaging arrangements. Because applicant names can change, the application number and official applicant record are often more stable verification points than a name taken from an old package image.
Current pharmacy stock is even more specific. The existence of a listed product, an NDC or an active approval does not guarantee that a licensed pharmacy can obtain the medicine for a particular prescription. An approval record should therefore not be used as evidence for claims such as in stock, ready to ship or available nationwide.
For directory accuracy, product entries should identify the evidence date and distinguish verified regulatory facts from unverified commercial availability. The goal is to help readers understand who is associated with an approved generic product, not to promise access to a specific manufacturer.
A patient receiving generic amoxicillin/clavulanate may see a different company name or tablet appearance from a previous prescription. That difference is not automatically evidence of an incorrect medicine. Different approved generic products can have different imprints, inactive ingredients or labeling arrangements while meeting the applicable FDA requirements.
The key verification points are the complete two-ingredient drug name, strength pair, dosage form and actual product dispensed. The pharmacy can provide the relevant manufacturer or labeler information and NDC when appropriate. A manufacturer-directory entry can support that inquiry but should not replace the pharmacist's review.
The prescription and applicable substitution rules determine whether a generic product is appropriate. An approved immediate-release tablet cannot be substituted automatically for Augmentin XR, and a standard suspension should not be treated as interchangeable with ES-600. Generic manufacturer information is not a substitute for matching dosage forms and approved product identities.
The presence of several companies in this directory also does not create a recommendation to choose among them based on price, country of manufacture or brand recognition alone. Actual clinical suitability, lawful dispensing and product availability require separate professional assessment.
For broader commercial access questions, readers can consult the Augmentin buying guide or the Augmentin online pharmacy guide. The brand Augmentin vs generic comparison addresses the regulatory and product differences rather than providing a manufacturer ranking.
Multiple companies are associated with FDA-approved amoxicillin/clavulanate products in U.S. regulatory and labeling records. Examples include Aurobindo Pharma, Teva Pharmaceuticals USA, Sandoz and Dr. Reddy's. Their precise roles vary by product and may include ANDA holder, manufacturer, distributor or labeler. Current manufacturing and marketing status must be checked for each application.
No. The name may identify a labeler, distributor or repackager rather than the company that physically manufactured the medicine. FDA application records and product-specific labeling are needed to distinguish these roles.
An ANDA holder is the entity legally responsible for an FDA-approved Abbreviated New Drug Application. The holder may be different from the physical manufacturer, commercial distributor or company named as the package labeler.
Search the FDA Orange Book for the complete ingredient combination and relevant dosage form, then identify the approved applicant and application number. DailyMed labeling can provide additional information about the product's labeler, NDC, package and documented manufacturing roles.
The FDA Orange Book identifies approved drug products, application holders and applicable therapeutic-equivalence information. DailyMed provides published labeling that can include the labeler, dosage form, strength, package NDC and manufacturing-establishment information. The resources are complementary rather than interchangeable.
No. Approval is product- and application-specific. A company may be associated with only certain strength pairs or dosage forms. Conventional tablets, chewable tablets, oral suspensions and extended-release formulations require separate verification.
FDA approval records include conventional immediate-release tablet strengths such as 250 mg/125 mg, 500 mg/125 mg and 875 mg/125 mg. The approved applicant and therapeutic-equivalence status must be verified for each product. The presence of a labeled strength does not establish current retail inventory.
Yes. DailyMed includes Aurobindo Pharma Limited labeling for conventional tablets and standard oral suspensions. A September 2026 suspension label identifies ANDA 201090 for the 200 mg/28.5 mg and 400 mg/57 mg per 5 mL products.
Yes. Teva Pharmaceuticals USA appears in DailyMed records for amoxicillin/clavulanate combination formulations. For example, its published 400 mg/57 mg per 5 mL suspension record identifies ANDA 065089. Current manufacturing and commercial availability require separate confirmation.
Yes. DailyMed includes amoxicillin/clavulanate tablet and oral-suspension records associated with Sandoz and Dr. Reddy's. The exact current applicant, manufacturing role, approved strength and marketing status must be checked for each specific product.
No. A repackager handles an existing drug product and may assign a different package NDC without becoming the original ANDA holder or physical manufacturer. The source product and approved application should be traced separately.
No. An NDC is a drug-product or package identifier and does not independently establish FDA approval, therapeutic equivalence, authenticity or current availability. The relevant approval should be verified through FDA drug-approval records.
Yes. An ANDA may contain multiple approved product entries, each with its own product number and strength. The directory should distinguish the application holder from the individual approved products rather than counting every strength as a different manufacturer.
Chewable tablets are a separate dosage form with their own strength pairs and applicable approval records. They cannot be assumed equivalent to conventional tablets simply because an amoxicillin quantity matches.
Not automatically. Standard amoxicillin/clavulanate oral suspensions have different concentration pairs and ingredient ratios from Augmentin ES-600. A manufacturer associated with ordinary suspensions is not thereby established as an approved ES-600 generic manufacturer.
FDA records include historical approvals for extended-release amoxicillin/clavulanate products. The specific ANDA holder, therapeutic-equivalence information and current commercial status must be checked independently. A conventional immediate-release generic is not automatically an XR equivalent.
Yes. An authorized generic is marketed without the brand name under an approved brand NDA, while an independently approved generic has its own ANDA. Both categories require product-specific verification rather than identification by the word generic alone.
No. FDA approval, commercial marketing, active manufacturing and local pharmacy inventory are separate questions. An approved or historically labeled product may not be available at a particular pharmacy.
A pharmacy may be able to identify the company associated with the product it proposes to dispense, but permitted substitution and actual inventory depend on the prescription, approved product and applicable pharmacy rules. Manufacturer preference does not authorize changing strength or dosage form independently.
No. This directory covers the two-ingredient amoxicillin/clavulanate combination. Plain amoxicillin products contain no clavulanate and have separate FDA approval and manufacturer records.