# AMOXICILLIN AND CLAVULANATE POTASSIUM (amoxicillin and clavulanate potassium) by REMEDYREPACK INC.: new human prescription drug listing

**Launch Signal Score:** 65/100

| Field | Value |
|---|---|
| Product | AMOXICILLIN AND CLAVULANATE POTASSIUM |
| Generic name | amoxicillin and clavulanate potassium |
| NDC | 70518-4758 |
| Labeler | REMEDYREPACK INC. |
| Product type | HUMAN PRESCRIPTION DRUG |
| Approval pathway | NDA AUTHORIZED GENERIC |
| Application number | NDA050720 |
| Dosage form | TABLET, COATED |
| Route | ORAL |
| Active ingredients | AMOXICILLIN 875 mg/1; CLAVULANATE POTASSIUM 125 mg/1 |
| Marketing start | 2026-09-21 |
| Package configurations | 1 |

## Why this score
- Prescription or biologic product.
- New generic entry: wholesalers and GPOs re-bid contracts.

Source: U.S. FDA National Drug Code (NDC) Directory via openFDA (https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=70518-4758). Last refreshed: 2026-11-04T18:12:05.743Z.
Listing data comes from the FDA NDC directory via openFDA; a listing is not an FDA approval or endorsement and may be updated or withdrawn. Informational only; not medical advice.