Prescription drug · ANDA
Amoxicillin and Clavulanate Potassium NDC 85766-268
Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1 · Tablet, Film coated · Oral · Sportpharm LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85766-268-01 | 85766026801 | 100 POUCH in 1 BOX (85766-268-01) / 1 TABLET, FILM COATED in 1 POUCHMarketed from Aug 29, 2026 | |
| 85766-268-03 | 85766026803 | 30 TABLET, FILM COATED in 1 BLISTER PACK (85766-268-03)Marketed from Aug 29, 2026 | |
| 85766-268-10 | 85766026810 | 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (85766-268-10)Marketed from Aug 29, 2026 | |
| 85766-268-14 | 85766026814 | 14 TABLET, FILM COATED in 1 BLISTER PACK (85766-268-14)Marketed from Aug 29, 2026 | |
| 85766-268-20 | 85766026820 | 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (85766-268-20)Marketed from Aug 29, 2026 | |
| 85766-268-30 | 85766026830 | 30 TABLET, FILM COATED in 1 BLISTER PACK (85766-268-30)Marketed from Aug 29, 2026 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Amoxicillin and Clavulanate Potassium
- Generic name (nonproprietary)
- amoxicillin and clavulanate potassium
- Active ingredients
- Amoxicillin — 875 mg/1Clavulanate potassium — 125 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Sportpharm LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091568
- Marketing start
- Listing expires
- Other FDA classes
- Penicillins (Chemical structure)beta Lactamase Inhibitors (Mechanism)
- Identifiers
- Product ID 85766-268_5a2933c3-6736-9257-e063-6294a90aea86SPL ID 5a2933c3-6736-9257-e063-6294a90aea86SPL set ID 69e45bc0-de57-4603-a9eb-335988dfe0bfRxCUI 562508UNII 804826J2HU, Q42OMW3AT8
- Pharmacologic class
- Penicillin-class Antibacterial; beta Lactamase Inhibitor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N485766026801followed by a unit qualifier and the quantityPackage 85766-0268-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Amoxicillin and clavulanate potassium tablets are indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below: Lower Respiratory Tract Infections - caused by beta‑lactamase‑producing isolates of Haemophilus influenzae and Moraxella catarrhalis . Acute Bacterial Otitis Media - caused by beta‑lactamase‑producing isolates of H. influenzae and M. catarrhalis . Sinusitis - caused by beta‑lactamase‑producing isolates of H. influenzae and M. catarrhalis . Skin and Skin Structure Infections - caused by beta‑lactamase‑producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella speci…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 091568
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Amoxicillin and Clavulanate Potassium | Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | Sportpharm LLC | 85766-019 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-4413 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-3864 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-3860 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-1809 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-2225 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-4586 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-4541 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-585 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8836 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-0822 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-201 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0279 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | Sportpharm LLC | 85766-078 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 82868-067 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-5847 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | NorthStar Rx LLC | 16714-297 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-5295 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-503 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-014 |
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