Drug company (FDA labeler)
USAntibiotics, LLC
NDC labeler code: 81964
What is a labeler?
The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.
Official FDA data only
Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.
Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.
Prescription medicines
FDA applications for these products
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| September 25, 2002 | NDA050785 | Amoxicillin and clavulanate potassium (amoxicillin / amoxicillin sodium / clavulanate potassium) AUGMENTIN XR | Us Antibiotics |
| June 22, 2001 | NDA050755 | Amoxicillin and clavulanate potassium (amoxicillin / clavulanate) AUGMENTIN ES-600 | Us Antibiotics |
| April 15, 1999 | NDA050760 | Amoxicillin AMOXIL | Us Antibiotics |
| February 13, 1996 | NDA050720 | Amoxicillin and clavulanate potassium (amoxicillin / clavulanate) AUGMENTIN '875' | Us Antibiotics |
| August 6, 1984 | NDA050575 | Amoxicillin and clavulanate potassium (amoxicillin / clavulanate) AUGMENTIN '125', AUGMENTIN '250' | Us Antibiotics |
| August 2, 1979 | ANDA062216 | Amoxicillin AMOXIL | Us Antibiotics |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
No recall of these products (by NDC code) appears in the FDA enforcement reports.
Next steps
- Find a pharmacy near youAsk which company made your medicine and whether it is recalled
- Latest FDA drug recallsAll companies, newest first
- All drug companiesA to Z
- All prescription drugs A to ZSearch by generic, brand or Spanish name
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026