Prescription drug · ANDA
Amoxicillin and Clavulanate Potassium NDC 68071-5065
Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1 · Tablet, Film coated · Oral · NuCare Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-5065-2 | 68071506502 | 2 TABLET, FILM COATED in 1 BOTTLE (68071-5065-2)Marketed from Jun 18, 2026 | |
| 68071-5065-3 | 68071506503 | 3 TABLET, FILM COATED in 1 BOTTLE (68071-5065-3)Marketed from Sep 20, 2019 | |
| 68071-5065-4 | 68071506504 | 4 TABLET, FILM COATED in 1 BOTTLE (68071-5065-4)Marketed from Sep 20, 2019 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- NuCare Pharmaceuticals,Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091569
- Marketing start
- Listing expires
- Other FDA classes
- Penicillins (Chemical structure)beta Lactamase Inhibitors (Mechanism)
- Identifiers
- Product ID 68071-5065_548e0a1b-57c5-9249-e063-6294a90a59d1SPL ID 548e0a1b-57c5-9249-e063-6294a90a59d1SPL set ID 92ff1408-512c-d68d-e053-2a95a90adfbdRxCUI 562508UNII 804826J2HU, Q42OMW3AT8UPC 0368071506525
- 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
N468071506502followed by a unit qualifier and the quantityPackage 68071-5065-02. 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)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets and other antibacterial drugs, amoxicillin and clavulanate potassium tablets should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Amoxicillin and clavulanate potassium tablets are a combination penicillin-class antibacterial and beta-lactamas…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 091569
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 500 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-533 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-0820 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-3947 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | Sportpharm LLC | 85766-079 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 250 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | Sportpharm LLC | 85766-080 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 250 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | NorthStar Rx LLC | 16714-295 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | NorthStar Rx LLC | 16714-296 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-502 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 250 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-501 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8317 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | Sportpharm LLC | 85766-022 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 250 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-781 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-792 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6997 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-2896 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-2933 |