Prescription drug · ANDA
amoxicillin and clavulanate potassium NDC 62135-091
Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1 · Tablet · Oral · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-091-20 | 62135009120 | 20 TABLET in 1 BOTTLE (62135-091-20)Marketed from Jul 21, 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 — 500 mg/1Clavulanate potassium — 125 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Chartwell RX, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065101
- Marketing start
- Listing expires
- Other FDA classes
- Penicillins (Chemical structure)beta Lactamase Inhibitors (Mechanism)
- Identifiers
- Product ID 62135-091_5b374f66-3baf-1ce0-e063-6394a90a8edaSPL ID 5b374f66-3baf-1ce0-e063-6394a90a8eda
- 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
N462135009120followed by a unit qualifier and the quantityPackage 62135-0091-20. 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
The FDA listing for this product does not reference a label (SPL) set.
Other NDCs under ANDA 065101
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 | Proficient Rx LP | 63187-327 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals USA, Inc. | 0093-2274 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-418 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-032 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 55289-845 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-608 |