U.S. Amoxicillin Manufacturers and Labelers

Four Company Roles Behind One Generic Prescription

The ANDA applicant or holder is the company associated with the FDA generic approval for a specified dosage form and strength. An application may include several strengths, each with its own approved product number, and its owner can change over time. Because this is an application-level relationship, the correct question is not simply “Who makes amoxicillin?” but “Which approved application covers this exact product, and who is the applicant shown on the record being checked?” The name on a retail label cannot answer that question alone.

The physical manufacturer performs manufacturing operations at one or more facilities. The NDC labeler is responsible for the drug-listing identity used in the NDC; it may manufacture, distribute under its own label or repackage a product made elsewhere. A repackager or relabeler may create a new patient- or unit-of-use package and assign a separate NDC while retaining a link to an original source NDC. These are roles, not mutually exclusive categories: one company can perform several of them.

A distributor named in prescribing information does not automatically prove where manufacturing occurred. Likewise, a facility address found in a labeling record does not prove that every amoxicillin product sold under the same corporate brand came from that site. A responsible directory records the role for each specific example and marks unknown manufacturing details as unverified rather than inferring them from company headquarters.

Dated U.S. Amoxicillin Company and Product Records

The entries below are documented examples, not an exhaustive roster of every approved company. They deliberately mix source manufacturers and labelers to show how a product moves from an application and manufacturing record to a U.S.-listed package. The product NDC and application number are identifiers; package counts and stated dates describe the recorded presentation. A DailyMed version date is a record timestamp, not the day the medicine was produced or a promise that a pharmacy can obtain it.

Read the “role and manufacturing evidence” column before drawing conclusions. In particular, NorthStar and Preferred are not automatically the ANDA holders for their listed products, and the USAntibiotics authorized-generic entry follows an NDA pathway rather than a separate ANDA. Example records were reviewed for this editorial directory on October 9, 2026; their actual commercial status should be independently checked again at fulfillment.

Aurobindo and NorthStar: One Application, Different Names

The Aurobindo chain illustrates why looking up an NDC is better than guessing from a familiar corporate name. The 500 mg capsule listed under original NDC 65862-017 is associated with ANDA 065271, and U.S. labeling identifies Aurobindo Pharma Limited as the manufacturer. The application also encompasses a 250 mg capsule product. This is an approval relationship for oral capsules, not a blanket statement that every amoxicillin dosage form marketed by any Aurobindo-related company has the same application.

NorthStar Rx has its own 500 mg capsule listings, including NDC 16714-299-03 for a documented 100-count bottle. The corresponding label names Aurobindo Pharma Limited as manufacturer and identifies the same ANDA 065271. It would be misleading to add NorthStar to a list of separate amoxicillin factories solely because NorthStar has a distinct labeler code. The relevant commercial difference is the labeled product and package record that the dispensing pharmacy can actually identify.

Some repackagers introduce a third visible name on top of this chain. For a patient who receives a pharmacy vial rather than a sealed original bottle, it is reasonable to ask the pharmacist for the manufacturer or labeler and, where available, the source product information. The capsule product catalog covers imprints and capsule packaging in greater detail; this directory explains the company relationships behind those appearances.

Hikma: Application Records, U.S. Distribution and Overseas Manufacture

A documented Hikma 875 mg coated-tablet record uses NDC 0143-9285 and ANDA 065255. The labeling distinguishes Hikma Pharmaceuticals USA Inc. as the U.S. distributor from Hikma Pharmaceuticals in Jordan as the manufacturer. Neither the U.S. name nor the manufacturing country changes what “875 mg amoxicillin tablet” means on the approved product record. The relevant identification remains the ingredient, dosage form, strength and linked approval.

A separate Hikma capsule source, such as the 500 mg product under NDC 0143-9939, is associated with another application, ANDA 065291. This illustrates why two products from one manufacturer must not be merged into a single undifferentiated ANDA listing. Application number, strength and form should stay attached to their own row when a directory is updated.

Hikma-linked oral suspensions offer a further distinction: Preferred Pharmaceuticals has relabeled a 125 mg/5 mL product under NDC 68788-9019-1, with a source relationship to NDC 0143-9888 and ANDA 065322. The original labeling identifies Hikma as manufacturer, while Preferred is the relabeler for that package. That is a documented chain, not evidence that Preferred manufactures the powder or that the item is available for a same-day fill. The liquid-product guide separately addresses concentrations, preparation and the filled bottle.

Teva Canada and the Chewable-Tablet Repackaging Trail

The amoxicillin chewable-tablet record using source NDC 0093-2268 is a useful case because its label identifies Teva Canada Limited as the manufacturer for a 250 mg chewable form supplied to the U.S. market. The related approval trail is ANDA 064013. A-S Medication Solutions lists repackaged presentations under NDC 50090-0454, including a 30-tablet package coded 50090-0454-0. The A-S NDC is not proof of a new A-S factory or a separate generic approval.

Some labels preserve older prescribing-information revisions while newer repackaged listings appear elsewhere. That is why a directory should display the source’s revision date, the listing’s effective date when available, and the date the record was checked. A 2015 label can demonstrate a historical manufacturing relationship without proving that a named NDC remains available for ordering in October 2026.

Chewable products can differ materially in flavor, excipients, appearance and strength from conventional tablets. The corporate chain cannot substitute for verifying the exact formulation, especially when a child or another patient needs a particular dosage form. The chewable-amoxicillin catalog covers those product-specific details without using this directory to recommend an individual dose.

Why USAntibiotics Is Not Another ANDA Entry

USAntibiotics, LLC illustrates a regulatory category that can be lost when every nonbranded package is called an “ANDA generic.” Its 400 mg/5 mL amoxicillin suspension family, including NDC 81964-207-52, is labeled NDA authorized generic, NDA 050760. DailyMed lists USAntibiotics as the labeler and as an establishment performing manufacturing operations for that product family. The published label was updated July 7, 2026.

An authorized generic may be sold under a nonbrand presentation while remaining linked to a brand-origin NDA. It should not be mislabeled as a separately approved ANDA product. Conversely, an ANDA product should not be called an authorized generic just because its appearance resembles a branded tablet or it comes from a well-known factory.

This matters to a buyer who wants to understand precisely what pharmacy documentation means. An NDA/ANDA distinction is not a recommendation to prefer one product over another, and the labeler’s marketing status does not establish patient-specific suitability, comparative safety or pharmacy inventory. Check the product’s approval and formulation separately from its current commercial offer.

How to Trace a Package From NDC to Source

A full package NDC has labeler, product and package segments. The labeler segment is useful for identifying the company that submits the listing, while the other segments distinguish the listed product and packaged presentation. When a repackager assigns a new identifier, a DailyMed record may also show the source NDC in parentheses. For instance, an A-S chewable listing references the Teva-origin 0093-2268 product; a Preferred suspension listing references Hikma’s 0143-9888 product. Those relationships are more probative than assuming that identical pill imprints always indicate the same commercial package.

Start with the exact code from an actual manufacturer bottle or pharmacy documentation, including the package segment when available. Confirm the ingredient is plain amoxicillin, then match the dosage form, strength, labeler, approval category and the record version. If the NDC belongs to a repackager, follow the listed source product before making any statement about original manufacture. A partial NDC, an unverified photograph or a retailer search title is not enough to certify a particular factory.

NDC entries are submitted by labelers, and FDA explicitly does not treat an NDC assignment as evidence of approval. A listing may be marked active while an individual pharmacy has no inventory, and the reverse problem—an outdated web listing—also occurs. This is why product-identification checks and questions to the dispensing pharmacist still matter even when the directory has a valid application trail.

What to Confirm in the Orange Book

The Orange Book is the starting point for identifying an approved prescription product and its application applicant. Search by amoxicillin and then narrow by dosage form, strength and, if known, the application number. An ANDA for a 500 mg capsule should not be used to validate an unrelated 400 mg/5 mL suspension. An application number is meaningful only alongside the precise product entry it covers.

Review the applicant, NDA or ANDA type, product number and therapeutic-equivalence notation, where one is provided. An AB designation in the appropriate FDA context concerns therapeutic equivalence to a relevant reference product; it is not permission for a consumer to swap formulations or doses without professional evaluation. FDA’s approval listing and DailyMed’s labeler-submitted package record should agree on the product identity even though they may name different companies for distinct roles.

An older record may use a former applicant name or document a marketing state that has since changed. Before describing a company as the current ANDA holder, confirm that the latest Orange Book information supports the claim. If only a published label and a historical application association can be confirmed, this directory identifies the application trail without representing the labeler as the present legal application owner. The FDA-approved-products overview addresses broader approval and product-class verification.

U.S. Label Does Not Necessarily Mean U.S. Manufacture

Companies can manufacture an FDA-approved product outside the United States and distribute it through a U.S. affiliate or labeler. The Aurobindo and Hikma examples illustrate this: a U.S. distributor or labeler appears on the package, while manufacturing information in the relevant label identifies a facility in India or Jordan. A domestic address on the label should never be rewritten as the manufacturing location without direct evidence.

The inverse is equally important. A foreign-sounding name does not establish that a product was unlawfully imported, unapproved or unsuitable for dispensing in the United States. FDA approval, establishment operations, product listing and lawful pharmacy dispensing are distinct questions. A manufacturer directory should report the documented country only for the particular labeled product, not rank countries or invent quality differences.

How This Directory Helps With Real Pharmacy Questions

One patient receives blue-and-pink A45 capsules after previously receiving a different-looking generic. The NorthStar label may show an Aurobindo manufacturing link, but pill appearance and a manufacturer name cannot resolve every discrepancy. The pharmacist can compare the actual dispensed NDC, the prescription, the product imprint and the relevant label. This avoids equating a change in color with either a safety problem or a guaranteed equivalent fill.

Another buyer sees a lower-cost 875 mg tablet listing from a pharmacy but the product page names a distributor rather than a factory. The Hikma example shows how to trace from the listed manufacturer or labeler to a defined FDA application. The buyer’s practical decision still concerns a lawful prescription, correct single-ingredient product, pharmacy confirmation and total payment; this company directory is not a price-comparison service. The separate tablet catalog explains physical tablet identification.

A caregiver finds a liquid amoxicillin product under a repackager’s name. Checking the NDC and source relationship can show which original labeled product the repackager used, but it does not establish that a prescribed concentration or prepared volume can be replaced with another. If the exact liquid is unavailable, the dispensing pharmacist should clarify the order with the prescriber as needed rather than inviting caregiver-led conversion between strengths.

Why This Is Not a Ranking of the Best Amoxicillin Manufacturer

A ranked list would require transparent, comparable evidence about actual products and current performance, not only manufacturer names. Application approvals, package identifiers and manufacturing locations are useful for identity checks but cannot support claims that one company’s amoxicillin is universally safer, stronger or more effective than another FDA-approved appropriate product. Manufacturing-quality enforcement information and a particular product’s current regulatory status also require separate, dated verification.

There is no verified list of named U.S. pharmacies and offers on this page, so it would be misleading to attach prices, product availability or “top manufacturer” badges to the entities in the directory. A patient filling an existing prescription should compare the exact prescribed form and quantity through a licensed dispenser. The prescription-pharmacy buying guide covers that purchasing workflow, while company records remain a means of checking identity.

Maintaining a Trustworthy Manufacturer Directory

Company names change through acquisitions, approval transfers and private-label agreements. NDC listings can start, end or be republished with revised labeling, while an original ANDA may continue to cover the underlying product. A responsible update therefore checks all of the following together: application/product number, applicant name, source and package NDC, listed labeler, manufacturing statement if available, dated label revision and any marketing end-date indication. This directory’s example records were reviewed October 9, 2026, and their original label dates are shown in the table rather than being replaced by the review date.

For an actual purchase, the final check belongs to the dispensing pharmacy. Confirm the exact medicine, prescribed strength, dosage form, quantity and any documented ingredient concerns; ask the pharmacist to explain an unexpected labeler or manufacturer name. If a product is missing, confusingly described or inconsistent with the prescription, request clarification rather than assuming that two corporate listings represent interchangeable products. Ordinary amoxicillin and amoxicillin/clavulanate are different active-ingredient combinations, so this directory does not extend to generic Augmentin manufacturer records.