Register entry
- Registered sites
- 1
- Active NDC listings
- 11
- Live patents
- 0
- Countries
- 1
- Base
- United States
Authorisation
Registered operations
Analytical testing1Finished drug manufacture1Packaging1
Sites
Registered establishments
1| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| USAntibiotics, LLC | 201 Industrial Drive, Bristol, Tennessee (TN) 37620, United States (USA) | Analytical testing, Finished drug manufacture, Packaging | 1047293118085486 |
Catalogue
Drug listings by form and route
1111 active NDC listings: 11 human prescription drug. By marketing category: NDA AUTHORIZED GENERIC 7, ANDA 3, NDA 1.
| Dosage form | NDCs |
|---|---|
| for suspension | 5 |
| capsule | 3 |
| tablet, coated | 2 |
| tablet, film coated, extended release | 1 |
| Route | NDCs |
|---|---|
| oral | 11 |
| Labeller name on the listing | NDCs |
|---|---|
| usantibiotics, llc | 11 |
Catalogue
Marketed products
11| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| AMOXICILLIN | Amoxicillin | capsule, oral | 81964-205ANDA |
| AMOXICILLIN | Amoxicillin | capsule, oral | 81964-225ANDA |
| AMOXICILLIN | Amoxicillin | capsule, oral | 81964-350ANDA |
| AMOXICILLIN AND CLAVULANATE POTASSIUM | amoxicillin and clavulanate potassium | for suspension, oral | 81964-203NDA AUTHORIZED GENERIC |
| AMOXICILLIN AND CLAVULANATE POTASSIUM | Amoxicillin and Clavulanate Potassium | for suspension, oral | 81964-204NDA AUTHORIZED GENERIC |
| AMOXICILLIN AND CLAVULANATE POTASSIUM | Amoxicillin and Clavulanate Potassium | for suspension, oral | 81964-212NDA AUTHORIZED GENERIC |
| AMOXICILLIN AND CLAVULANATE POTASSIUM | amoxicillin and clavulanate potassium | tablet, coated, oral | 81964-221NDA AUTHORIZED GENERIC |
| AMOXICILLIN AND CLAVULANATE POTASSIUM | amoxicillin and clavulanate potassium | tablet, coated, oral | 81964-575NDA AUTHORIZED GENERIC |
| AUGMENTIN ES-600 | amoxicillin and clavulanate potassium | for suspension, oral | 81964-003NDA |
| Amoxicillin | Amoxicillin | for suspension, oral | 81964-207NDA AUTHORIZED GENERIC |
| Amoxicillin and Clavulanate Potassium | amoxicillin and clavulanate potassium | tablet, film coated, extended release, oral | 81964-220NDA AUTHORIZED GENERIC |
Neighbours
Registered in the same town
1- Kingsway Pharmaceuticals dba NFI, LLCBristol, TN
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Enquiry
Common questions
- Is USAntibiotics, LLC FDA approved?
- USAntibiotics, LLC holds 1 FDA-registered establishment in the United States. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
- Where are USAntibiotics, LLC's drugs manufactured?
- The FDA register lists Bristol, TN. Registered operations: analytical testing, finished drug manufacture, packaging.
- What drugs does USAntibiotics, LLC make?
- 11 products are listed under USAntibiotics, LLC in the openFDA NDC Directory, most often as for suspension; capsule; tablet, coated. The full breakdown by dosage form and route is above. A listing count is not a sales figure.
Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.